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Surgical treatment of morbid obesity An update

AGENCE D’ÉVALUATION DES TECHNOLOGIES ET DES MODES D’INTERVENTION EN SANTÉ

Surgical Treatment of Morbid Obesity

An Update

August 2006(Original French version published in October 2005)

Report prepared for AETMIS by by Raouf Hassen-Khodja and Jean-Marie R. Lance

This report was translated from an offi cial French publication of the Agence d’évaluation des technologies et des modes d’intervention en santé (AETMIS). Both the original report, titled Le traitement chirurgical de l’obésité morbide : mise à jour and the English report are available in PDF format on the Agency’s Web site.

Scientifi c reviewDr. Véronique Déry, Chief Executive Offi cer and Scientifi c Director

TranslationJocelyne Lauzière, M.A., Certifi ed Translator

Editorial supervisionSuzie Toutant

Page layoutJocelyne Guillot

ProofreadingFrédérique Stephan

Bibliography researchDenis Santerre

Co-ordinationLise-Ann Davignon

Communications and disseminationDiane Guilbault

For further information about this publication or any other AETMIS activity, please contact:

Agence d’évaluation des technologies et des modes d’intervention en santé2021, Union Avenue, Suite 1040Montréal (Québec) H3A 2S9

Telephone: (514) 873-2563Fax: (514) 873-1369E-mail: [email protected]

How to cite this document:

Agence d’évaluation des technologies et des modes d’intervention en santé (AETMIS). Surgical Treatment of Morbid Obesity: An Update. Report prepared by Raouf Hassen-Khodja and Jean-Marie R. Lance (AETMIS 05-04). Montréal: AETMIS, 2006, xvii-113 p.

Legal depositBibliothèque et Archives nationales du Québec, 2006National Library of Canada, 2006ISBN 2-550-45724-2 (Print) (French edition ISBN 2-550-45464-2)ISBN 2-550-45725-0 (PDF) (French edition ISBN 2-550-45465-0)

© Gouvernement du Québec, 2005.This report may be reproduced in whole or in part provided that the source is cited.

MISSION

The mission of the Agence d’évaluation des technologies et des modes d’intervention en santé (AETMIS) is to contribute to improving the Québec health-care system and to participate in the implementation of the Québec government’s scientifi c policy. To accomplish this, the Agency advises and supports the Minister of Health and Social Services as well as the decision-makers in the health-care system, in matters concerning the assessment of health services and technologies. The Agency makes recommen-dations based on scientifi c reports assessing the introduction, diffusion and use of health technologies, including assistive devices for disabled persons, as well as the modes of providing and organizing ser-vices. The assessments take into account many factors, such as effi cacy, safety and effi ciency, as well as ethical, social, organizational and economic implications.

EXECUTIVE

Dr. Luc DeschênesCancer Surgeon, President and Chief Executive Offi cer of AETMIS, Montréal, and Chairman, Conseil médical du Québec, Québec

Dr. Véronique DéryPublic Health Physician, Chief Executive Offi cer and Scientifi c Director

BOARD OF DIRECTORS

Dr. Jeffrey BarkunAssociate Professor, Department of Surgery, Faculty of Medicine, McGill University, and Surgeon, Royal Victoria Hospital (MUHC), Montréal

Dr. Marie-Dominique BeaulieuFamily Physician, Holder of the Dr. Sadok Besrour Chair in Family Medicine, CHUM, and Researcher, Unité de recherche évaluative, Hôpital Notre-Dame (CHUM), Montréal

Dr. Suzanne ClaveauSpecialist in microbiology and infectious diseases, Hôtel-Dieu de Québec (CHUQ), Québec

Roger JacobBiomedical Engineer, Coordinator, Capital Assets and Medical Equipment, Agence de la santé et des services sociaux de Montréal, Montréal

Louise MontreuilAssistant Executive Director, Direction générale de la coordination ministérielle des relations avec le réseau, ministère de la Santé et des Services sociaux, Québec

Dr. Jean-Marie MoutquinObstetrician/Gynecologist, Research Director, and Executive Director, Département d’obstétrique-gynécologie, CHUS, Sherbrooke

Dr. Réginald NadeauCardiologist, Hôpital du Sacré-Cœur, Montréal, Board Member of the Conseil du médicament du Québec

Guy RocherSociologist, Professor, Département de sociologie, and Researcher, Centre de recherche en droit public, Université de Montréal, Montréal

Lee SoderströmEconomist, Professor, Department of Economics, McGill University, Montréal

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Dr. Reiner BankenPhysician, Deputy Chief Executive Offi cer, Development and Partnerships

Dr. Alicia FramarinPhysician, Deputy Scientifi c Director

Jean-Marie R. LanceEconomist, Senior Scientifi c Advisor

Lucy BoothroydEpidemiologist, Scientifi c Advisor

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FOREWORD

SURGICAL TREATMENT OF MORBID OBESITY: AN UPDATE

Obesity is now considered a major public-health problem and has even been declared a “global epidemic” by the World Health Organization (WHO). This chronic disease, which results from numerous biological, environmental and behavioural factors, leads to several health problems, including hypertension, dyslipidemia, diabetes and some cardiovascular disorders. Québec has not been spared from this epidemic, with a rate of obesity that reached 21.8% in 2004.

In practice, obesity is defi ned as a body-mass index (BMI) greater than 30 kg/m2. A more critical threshold is attained when the BMI reaches 40, or even only 35 if it is associated with co-morbidities. This is referred to as morbid obesity. In such cases, behavioural and medical therapy fail to achieve long-term weight reduction and, according to the WHO, surgery is the only effective treatment. However, owing to the expanding range of surgical techniques and the recent introduction of laparoscopic approaches, legitimate questions have been raised about the effi cacy and risks of these major procedures.

As early as 1998, the Agence d’évaluation des technologies et des modes d’intervention en santé (AETMIS) had produced a report on the surgical treatment of morbid obesity, or bariatric surgery. At that time some techniques had been classifi ed as accepted technologies, but another, performed in a Québec hospital, was still considered experimental. The rapid evolution of bariatric surgery and of the scientifi c evidence on this topic has prompted the need for an update. Moreover, faced with the growing prevalence of morbid obesity and concerned about the effi cacy of the different techniques and the need to provide effective management for those affected by this health problem, the Ministère de la Santé et des Services Sociaux (MSSS) asked AETMIS to assess this surgical treatment.

This report examines the effi cacy and risks of complications pertaining to the four major types of procedures, including those performed in Québec. It also compares abdominal-incision approaches with laparoscopic approaches, and deals with the economic aspects of this treatment. The primary sources for this analysis were scientifi c articles and health-technology assessment reports published since 1998.

Results confi rm the long-term effi cacy of surgical treatment in terms of maintaining weight loss and reducing co-morbidities. The different techniques available in Québec are considered effi cacious and safe. Some have proven effi cacy, while others continue to require close follow-up so that patient indications and eligibility may be better identifi ed. In conclusion, AETMIS recommends that an action plan be developed to clearly defi ne the needs for bariatric surgery and establish the means to meet those needs; that key conditions be determined to ensure that hospital centres offer high-quality bariatric treatment; and that a registry on morbid obesity and its management be established.

In submitting this report, AETMIS hopes to contribute to improving the health and quality of life of people with morbid obesity.

Dr. Luc DeschênesPresident and Chief Executive Offi cer

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ACKNOWLEDGEMENTS

This report was prepared at the request of AETMIS by Raouf Hassen-Khodja, MD, MSc (health administration), physician (hemobiology) and consultant researcher, and by Jean-Marie R. Lance, MSc (economics), senior scientifi c advisor.

AETMIS would like to thank the following external reviewers for their valuable comments on this report:

Mitiku Belachew, MDProfessor, University Surgery Department, Centre hospitalier régional de Huy, Huy , Belgium

Nicholas V. Christou, MDSurgeon and professor of surgery, McGill University Health Centre, Montréal, Québec

Slim Haddad, MDAssociate professor, Department of Social and Preventive Medicine, Faculty of Medicine, and economist, Université de Montréal, Montréal, Québec

Picard Marceau, MDProfessor, Department of Surgery, Université Laval, and surgeon, Hôpital Laval, Quebec City, Québec

Jean Mouïel, MDProfessor, Nice Faculty of Medicine, and specialist in digestive surgery, Centre de chirurgie et laparoscopie, Nice, France

Nicola Scopinaro, MDProfessor, Department of Surgery, Faculty of Medicine, Università di Genova, Ospedale San Martino, Genoa, Italy

Rudolf Steffen, MDFMH specialist in visceral surgery, Bern, Switzerland

DISCLOSURE OF CONFLICTS OF INTEREST

None declared.

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SUMMARY

MORBID OBESITYSince 1998, in the wake of a report by the World Health Organization (WHO), obesity has been considered a major public-health problem and has even been declared a “global epidemic.” The WHO even calls it a chronic disease requiring long-term strategies for effective prevention and management. Obesity is the result of complex interactions of metabolic, endocrine, genetic, socio-economic, environmental, cultural, psychological and behavioural factors. It causes many diseases, including hypertension, hyperlipidemia, diabetes, some cardiovascular disorders, sleep apnea, osteoarthritis and some cancers, and even death.

Defi nition

Obesity is characterized by excess body fat and is generally defi ned by the body-mass index (BMI), which takes into account weight and height. This index is expressed in kilograms per square metre (kg/m2). The term obesity applies when the BMI is greater than or equal to 30 kg/m2. A BMI between 25 and 29.9 kg/m2 is called overweight. Morbid obesity refers to a BMI that is greater than or equal to 40, or 35 kg/m2 if associated with co-morbidities.

Prevalence

The prevalence of obesity (BMI ≥ 30) in the household population aged 18 and older (excluding pregnant women) is growing steadily. Whereas obese people accounted for only 13.8% of Canada’s population in 1978–1979, this proportion rose to 23.1% in 2004; these fi gures are based on directly measured height and weight. The gap between men and women is small: 22.9% vs 23.2%. The situation is comparable in Québec, which has an overall rate of 21.8% (20.9% for men and 22.7% for women). Morbid obesity (BMI ≥ 40) has also risen dramatically in Canada, from 0.9% in

1978–1979 up to 2.7% in 2004, with women being more affected by this problem (3.8% vs 1.6% for men). This fi gure is not available for Québec.

Consequences

Obesity gives rise to a considerable epidemiological and economic burden. According to studies in the United States, where the rate of obesity during the 1999–2002 period reached 31.1% among people aged 20 to 74, this problem caused at least 112,000 deaths per year, although other estimates combining overweight and obesity yielded more than 300,000 deaths. Controversy persists over the magnitude of this burden. From an economic viewpoint, Canada’s 1997 direct medical costs attributable to adult obesity were estimated to be $1.8 billion, or 2.4% of total direct medical costs. One study estimated that obesity in Québec led to expenditures totalling $700 million, or 5.8% of the province’s health-care budget (1999–2000 fi scal year), and to productivity losses in excess of $800 million.

ROLE OF SURGICAL TREATMENT IN THE THERAPEUTIC APPROACH TO OBESITYThe therapeutic approach to obesity is multi-faceted and complex. It requires a specially adapted treatment structure and the availability of a multidisciplinary team.

Management of obesity

Obesity management is based on a minimum of three key measures:

1) intensive patient education on improving food patterns;

2) counselling on the need for regular physical activity; and

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3) behavioural approaches designed to help people better regulate the lifestyle habits needing to be modifi ed.

Weight-loss objectives must be clearly defi ned with the patient. Physicians may suggest drug therapy for patients unable to meet their target objectives through diet and physical activity.

Management of morbid obesity

The multi-dimensional approach described above is not effective for treating morbid obesity. According to the WHO, the only effective treatment is bariatric surgery (from the Greek word baros, which means weight).

Bariatric surgery currently encompasses a range of techniques that can be classifi ed into two main types of procedures:

gastric-restriction techniques, which decrease food intake by reducing gastric capacity: gastroplasty: a pouch or partition is

created by horizontal or vertical stapling or banding (vertical banded gastroplasty), gastric banding: a fi xed or adjustable band

is inserted to form a small-volume gastric reservoir;

hybrid techniques, which combine gastric restriction with the principle of intestinal malabsorption by creating either a bypass or a diversion system: gastric bypass techniques, including Roux-

en-Y, the most common variant performed worldwide, biliopancreatic diversion with distal

gastrectomy or duodenal switch.

Although all these surgical techniques were developed for the abdominal-incision, or open-surgery, approach (laparotomy), surgeons continued to explore new ways of performing this procedure, chiefl y in terms of the surgical approach. As a result, laparoscopic techniques appeared in the mid-1990s and soon became widely used in several countries. In fact, according to an international survey, 62.85% of

the procedures performed worldwide in 2003 were done laparoscopically, especially gastric bypass and adjustable gastric banding.

Although the effi cacy and safety of each of these techniques, whether open or laparoscopic, are established to varying degrees, they still raise legitimate questions.

ASSESSMENT OBJECTIVESIn 1998, the Conseil d’évaluation des technologies de la santé (the predecessor of AETMIS) published a report on the surgical treatment of morbid obesity. The need to clarify the status of biliopancreatic diversion with duodenal switch (the procedure used in Québec), the rapid expansion of laparoscopic techniques and the growing prevalence of morbid obesity are the reasons for this update. This report also responds to a request from the MSSS asking AETMIS to examine the evolving effi cacy of bariatric-surgery techniques and the best conditions for managing people with severe obesity. Lastly, this assessment explores the economic aspects of this treatment.

METHODOLOGYThis report is based on a review of the scientifi c literature and health-technology assessments published between 1998 (publication date of the previous report) and April 2005. Standard databases—Medline, Cochrane Library and HTA Database—were searched on the following keywords: obesity, morbid obesity, surgical treatment, bariatric surgery, gastroplasty, gastric bypass, gastric banding.

The search retrieved a large number of studies published since 1998. However, given the scarcity of comparative trials, whether randomized or not, and the predominance of case series, studies were selected by means of a simplifi ed grid containing the following elements: study design, publication date, number of patients treated, length of follow-up, and relevance of clinical outcome measures.

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The main evaluation criteria for this analysis were:

Clinical effi cacy: excess weight loss (EWL), defi ned in relation to ideal weight, or, alternatively, weight loss and a decrease in body-mass index; Safety: complications characterized by their

onset (short, medium or long term), type and severity; Co-morbidity: reduction or not of associated

conditions; Consumption of health goods or services

or other resources: days of hospitalization, mean length of stay, operating time; Effi ciency: resource costs or savings; cost-

effectiveness and cost-utility ratios.

RESULTSSurgical treatment in general

Despite the large number of primary studies on the surgical treatment of morbid obesity, most cover either treatments with established effi cacy or new approaches, especially laparoscopic procedures. Few provide long-term outcomes, however. A single major study (Swedish Obese Subjects Intervention Study, or SOS) compares surgical treatment with the medical approach. It uses a prospective design with 18 subject-matching variables. The other comparative studies, some of which were randomized, examined either the effects of the surgical approach (open or laparoscopy) or variants of the same technique. The studies are therefore mostly retrospective case series, while a few are prospective.

Surgical treatment is currently recognized as being a more effective therapeutic option than non-surgical treatment for patients who are morbidly obese. Although most of the evidence refers to short-term outcomes, several studies are beginning to demonstrate long-term sustained weight loss. Moreover, the SOS (the best controlled study available) found that bariatric surgery achieved a sustained weight loss of 16.1% in people with BMIs of at least 40,

or at least 35 if associated with co-morbidities, including diabetes, hyperlipidemia and hypertension. Surgery itself has some potentially serious complications. Although these adverse effects are generally managed appropriately, they require continual assessment.

Bariatric surgery remains an expensive procedure because it requires a multidisciplinary team, a specialized technical platform and long-term follow-up. In return, the resulting weight loss decreases the prevalence of co-morbidities and their consequences (prescription drug spending), serving to reduce productivity losses caused by sick leave and disability, and improves quality of life. Nevertheless, the favourable cost-effectiveness (or cost-utility) ratio and the effi ciency suggested by the current state of the evidence need to be confi rmed by longer-term well-designed economic studies.

Surgical techniques

Although bariatric surgery relies on a wide range of techniques, current evidence does not yet favour any one over the others, owing to the variety of contexts in which they are applied, the diversity of patient characteristics and the lack of well-designed controlled studies. Moreover, a single procedure may involve several techniques.

The choice of surgical technique depends on a number of factors:

Patient profi le: age, personality, BMI, food patterns, personal understanding and commitment, co-morbidities, contra-indications; Reversibility or non-reversibility of the

technique; Risks linked to each technique (e.g., wound

dehiscence, hernias, device slippage, staple-line failure); Potential effects of nutritional defi cits; Availability of human and material

resources; Support provided by the expertise of a

multidisciplinary team; and

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Surgical team’s experience in bariatric surgery and, where applicable, in laparoscopy, which requires a lengthy learning curve.

In terms of overall effi cacy, current evidence generally indicates that hybrid techniques combining gastric restriction and intestinal malabsorption are superior to those designed only to restrict gastric capacity. The following provides details regarding the main techniques under review, of which three are used in Québec.

Roux-en-Y gastric bypass (RYGB): This technique has proven effi cacy in terms of stable weight loss, low complication rates and reduction of co-morbidities. Considered the gold standard of weight-loss surgery, the RYGB is the most commonly used gastric-bypass technique.

Vertical banded gastroplasty (VBG): Although this technique has established effi cacy, it has achieved lower than expected weight loss and has lost favour with North American surgeons (including those in Québec). Combined with the RYGB, VBG yields good long-term results.

Adjustable gastric banding (AGB): This technique is generally recognized as being effective in terms of both weight loss and low complication rates. It has the advantage of being reversible and is increasingly replacing VBG.

Biliopancreatic diversion with duodenal switch (BPD-DS): Despite the fact that this technique is used only in a few centres because of its stringent requirements for post-operative patient management and follow-up, its long years in use (over 20 years), the cumulative number of procedures performed to date and its positive weight-reduction results mean that this procedure is no longer considered experimental. In addition, some studies suggest that BPD-DS would be appropriate for super-obese patients with BMIs over 50.

Laparoscopic approach

Laparoscopic procedures offer many advantages: they reduce hospital stays and decrease, if not eliminate, complications

associated with open surgery; however, they do have other types of complications. Surgeons must train in the best conditions to master this approach.

The two most advanced laparoscopic techniques are Roux-en-Y gastric bypass (LRYGB) and adjustable gastric banding (LAGB), and they are no longer considered experimental. They must nonetheless be introduced in an environment that permits the ongoing study of their effects. After one year of follow-up, the LRYGB achieves the same outcomes as the open version, and their early complications differ only slightly. However, it is still necessary to obtain longer-term comparative.

The LAGB techniques appear to be safe and effective (in terms of excess weight loss) and have the extra advantage of being reversible. Furthermore, major complications are rare, and complication and re-operation rates are acceptable. Yet these effects have been measured only in the short term and need to be confi rmed by longer studies.

The other laparoscopic techniques are still classifi ed as experimental, owing to the uncertainty surrounding their effects.

Lastly, in addition to offering no comparisons, the evidence on the surgical treatment of adolescents and children with morbid obesity is insuffi cient to draw valid conclusions. Although this assessment has not examined the consequences of substantial weight loss (e.g., the need for reconstructive plastic surgery), this aspect must not be overlooked in the therapeutic treatment plan because it has a potentially signifi cant psychological impact.

COST EFFECTIVENESS OF BARIATRIC SURGERYAccording to the current state of evidence, even if the published economic studies and models have their limitations, the surgical treatment of morbid obesity would appear to be a cost-effective procedure. Although this

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type of surgery is relatively expensive, mostly because of the costs incurred by the procedure itself and by the management of early or late complications than can result, and because of the requirement for annual follow-ups and the possible need for plastic surgery, the positive effects linked to weight reduction would appear to compensate for these costs. Indeed, bariatric surgery lowers the prevalence of co-morbidities (e.g., cardiovascular diseases and diabetes) and their impact on resource utilization (hospitalizations, drug expenditures). It also reduces productivity losses caused by sick leave and disability, and improves quality of life.

These initial results must nevertheless be confi rmed by more well-designed economic evaluations based on factual data on long-term effectiveness and resource utilization and on valid comparisons of the different surgical techniques and approaches (laparoscopy or open surgery).

CHALLENGES FOR QUÉBEC’S MEDICAL PRACTICEDifferent bariatric-surgery techniques are currently being used in Québec by highly experienced surgeons in the fi eld. Yet there is a lack of data on the quality and effectiveness of these procedures and on the population of treated patients. The supply of services also appears insuffi cient, given the steady growth of waiting lists and wait times. In such a context:

it is crucial to know and share all the different information about the treated population and the outcomes achieved in bariatric-surgery centres; it is necessary to effectively measure the

evolution and extent of bariatric-surgery needs resulting from the growing prevalence of morbid obesity; it is advisable to promote the development

of practice guidelines on the management of patients with morbid obesity in order to ensure that service offerings are of high quality.

Québec’s Association of General Surgeons (QAGS) has developed a policy on the surgical treatment of morbid obesity. The QAGS emphasizes the following points: need for an interdisciplinary team; designation of referral centres; information and training for surgical residents; and increased bariatric-surgery training opportunities. Furthermore, it would be advisable, in the management of any bariatric-surgery plan, to anticipate the potential need for reconstructive plastic surgery.

RECOMMENDATIONS1) It is recommended that the Ministère de

la Santé et des Services Sociaux and other decision makers concerned with the problem of morbid obesity identify current and future needs in bariatric surgery, establish an action plan to increase the capacity to provide this treatment, and ensure that patients in the different settings and regions have fair access to these services.

2) It is recommended that, at the organizational level, all hospital bariatric-surgery programs comply with the conditions listed below, which will be subject to a quality-assurance process. Such programs must:

Establish a strict patient-selection process (e.g., patients who have BMIs of 40 kg/m2 or more, or 35 with co-morbidities, who have acceptable operative risks, who are motivated and well informed of the inherent risks of the procedure and of the need for lifelong follow-up) and a system for prioritizing patients on scheduled waiting lists.

Have available facilities and equipment adapted to the specifi c profi le of the patients concerned (e.g., recovery rooms, intensive-care units, beds and furniture, diagnostic investigation tables, operating tables, and adapted surgical instruments).

Have an experienced multidisciplinary team capable of supplying the full range of care and services tied to this type of

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treatment: surgical team, psychologist, nutritionist, medical specialists (e.g., diabetologists, cardiologists, pneumologists).

Provide closely monitored lifelong follow-up, and cover the physical and psychological dimensions of this treatment, which consequently includes consultations linked to the need for plastic surgery.

3) It is recommended that a Québec registry on morbid obesity and its management be established. This registry will offer key support in implementing a regional follow-up program for operated patients by linking the different health-care structures (hospitals, health centres) and by including specifi c patient education on nutritional approaches appropriate for this type of patient. This data source will make it possible to determine the prevalence and categorization of the different patients, to evaluate the surgical procedures that are currently being performed and to rule on the new bariatric-surgery approaches.

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AGB Adjustable gastric banding

AHAL Ad hoc alimentary limb

AHFMR Alberta Heritage Foundation for Medical Research

AHRQ Agency for Healthcare Research and Quality

AHS Ad hoc stomach

ALOS Average hospital length of stay

ANAES Agence Nationale d’Accréditation et d’Évaluation en Santé

AOT Average operating time

ASBS American Society of Bariatric Surgery

ASERNIP-S Australian Safety and Effi cacy Register of New International Procedures – Surgical

BMI Body mass index (kg/m2). It is calculated by dividing weight (in kilograms) by height squared (in metres).

BPD Biliopancreatic diversion (open procedure)

BPD-DS Biliopancreatic diversion with duodenal switch

DG Distal gastrectomy

DS Duodenal switch

EWL Excess weight loss

FDA Food and Drug Administration

GB Gastric banding

GBP Gastric bypass (open procedure)

GPI Genuine Progress Index

INAHTA International Network of Agencies for Health Technology Assessment

LAGB Laparoscopic adjustable gastric banding

LBPD Laparoscopic biliopancreatic diversion

LBPD-DS Laparoscopic biliopancreatic diversion with duodenal switch

LGBP Laparoscopic gastric bypass

LRYGB Laparoscopic Roux-en-Y gastric bypass

LSAGB Laparoscopic Swedish adjustable gastric banding

LVBG Laparoscopic vertical banded gastroplasty

MAS Medical Advisory Secretariat

LIST OF ABBREVIATIONS

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MSAC Medical Services Advisory Committee

MUHC McGill University Health Centre

NAGB Non-adjustable gastric banding

NHMRC National Health and Medical Research Council

NICE National Institute for Clinical Excellence

OHTAC Ontario Health Technology Advisory Committee

QAGS Québec Association of General Surgeons

QALY Quality-adjusted life year

RYGB Roux-en-Y gastric bypass

SAGB Swedish adjustable gastric banding

SF-36 36-Item Short Form Health Survey

SOS Swedish Obese Subjects Intervention Study

TEC Technology Evaluation Center

VBG Vertical banded gastroplasty or silastic ring vertical gastroplasty

VBG-RYGB Vertical banded gastroplasty combined with Roux-en-Y gastric bypass

WHO World Health Organization

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GLOSSARY

AnastomosisConnection between two vessels and, by extension, between two conduits of the same type or between two nerves. It may be natural or surgically created.

ConversionIn this report, conversion refers to a surgical intervention that begins as a laparoscopic procedure and is completed as an open procedure.

DentitionSet of natural teeth.

Dumping syndromeSyndrome involving the rapid early gastric emptying of the operated stomach (partial gastrectomy and/or gastrojejunal anastomosis). It occurs when food or liquid passes too quickly into the intestine, causing digestive problems, discomforts, etc.

Excess weightExcess weight in relation to ideal weight calculated according to height and sex.

Excess weight loss (EWL) Excess weight loss achieved through diet or through medical or surgical treatment. EWL is measured by weight units (pounds or kilograms) or by a percentage (initial weight – current weight) / (initial weight – ideal weight).

Ideal weightThis weight is based on the tables produced by the Metropolitan Life Insurance Company (1979). It is evaluated according to average values that take into account height and sex.

Laparoscopy Visual examination directly in the abdominal cavity previously distended by means of an endoscope introduced through the abdominal wall for diagnostic or therapeutic purposes.

LaparotomySurgical incision through the abdominal wall and peritoneum. (Also called open surgery.)

PlicationSurgical technique which consists in folding an anatomical structure or organ to modify its position, shape or function, or to modify the position, shape or function of an adjacent organ.

Quality-adjusted life year (QALY)Calculation method allowing situations to be compared in relation to two criteria taken into account simultaneously, that is, effi cacy (number of life years gained) and the quality of life of those years.

SecretinHormone produced in the duodenum that activates the secretion of pancreatic juices (especially alkaline salts) and, to a lesser extent, bile, intestinal juices and saliva.

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TABLE OF CONTENTS

MISSION .......................................................................................................................................................... i

FOREWORD .................................................................................................................................................. iii

ACKNOWLEDGEMENTS ............................................................................................................................ iv

SUMMARY ..................................................................................................................................................... v

LIST OF ABBREVIATIONS ......................................................................................................................... xi

GLOSSARY .................................................................................................................................................. xiii

1 INTRODUCTION ...................................................................................................................................... 1

1.1 Defi nition of obesity .......................................................................................................................... 1

1.2 Burden of obesity ............................................................................................................................... 1

1.2.1 Prevalence .............................................................................................................................. 11.2.2 Mortality and economic impact .............................................................................................. 2

1.3 Role of surgical treatment in the therapeutic approach to obesity ..................................................... 2

1.4 Objective ............................................................................................................................................ 3

2 METHODOLOGY ..................................................................................................................................... 4

3 SURGICAL TECHNIQUES ...................................................................................................................... 6

3.1 Objectives of the surgical treatment of morbid obesity ..................................................................... 6

3.2 Description of the techniques ............................................................................................................ 6

3.2.1 Gastric-restriction techniques ................................................................................................. 63.2.2 Gastric bypass ......................................................................................................................... 83.2.3 Laparoscopic techniques ...................................................................................................... 103.2.4 Bariatric surgery with hand-assisted laparoscopy .................................................................11

4 STUDY OUTCOMES .............................................................................................................................. 12

4.1 Surgical vs non-surgical treatment of morbid obesity ..................................................................... 12

4.2 Effi cacy of the different surgical procedures ................................................................................... 13

4.2.1 By type of procedure ............................................................................................................ 134.2.2 Comparison of the techniques .............................................................................................. 24

4.3 Complications .................................................................................................................................. 30

4.3.1 Complications from gastric bypass ...................................................................................... 314.3.2 Complications from gastroplasty .......................................................................................... 314.3.3 Complications from biliopancreatic diversion ..................................................................... 314.3.4 Complications from laparoscopic procedures ...................................................................... 31

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4.4 Impact of bariatric surgery on obesity co-morbidities ..................................................................... 32

5 ECONOMIC OUTCOMES...................................................................................................................... 35

5.1 Results of the analysis of primary-data articles ............................................................................... 35

5.2 Modelling results ............................................................................................................................. 38

5.2.1 Model developed by Clegg ................................................................................................... 385.2.2 Model developed by Craig and Tseng .................................................................................. 39

5.3 Cost of bariatric-surgery procedures ................................................................................................ 39

5.4 Recapitulation of the economic evaluation ...................................................................................... 40

6 REVIEW OF THE VARIOUS HEALTH-TECHNOLOGY ASSESSMENT REPORTS ........................ 41

6.1 Bariatric surgery .............................................................................................................................. 41

6.2 Laparoscopic surgical procedures .................................................................................................... 43

7 DISCUSSION .......................................................................................................................................... 45

8 CONCLUSION ........................................................................................................................................ 49

8.1 General role of bariatric surgery ...................................................................................................... 49

8.2 The different surgical techniques ..................................................................................................... 49

8.3 Challenges for Québec’s medical practice ....................................................................................... 50

9 RECOMMENDATIONS .......................................................................................................................... 52

ABBREVIATIONS USED IN THE APPENDICES ..................................................................................... 53

APPENDIX A STATUS OF HEALTH TECHNOLOGIES : AETMIS CLASSIFICATION .................... 55

APPENDIX B OUTCOMES OF STUDIES ON VERTICAL BANDED GASTROPLASTY ................. 56

APPENDIX C OUTCOMES OF STUDIES ON GASTRIC BYPASS ..................................................... 58

APPENDIX D OUTCOMES OF STUDIES ON BILIOPANCREATIC DIVERSION ............................ 66

APPENDIX E OUTCOMES OF STUDIES ON GASTRIC BANDING ................................................. 70

APPENDIX F OUTCOMES OF STUDIES COMPARING DIFFERENT TYPES OF BARIATRIC SURGERY ................................................................................................... 85

APPENDIX G META-ANALYSIS OF THE IMPACT OF BARIATRIC SURGERY ON OBESITY CO-MORBIDITIES .................................................................................. 90

APPENDIX H DETAILED OUTCOMES OF ECONOMIC STUDIES ................................................... 92

APPENDIX I METROPOLITAN LIFE INSURANCE COMPANY TABLES ....................................... 98

APPENDIX J BAROS SCORING KEY .................................................................................................. 99

REFERENCES ............................................................................................................................................ 100

xvi

TABLES AND FIGURES

Figure 1 Vertical banded gastroplasty ...................................................................................................... 7Figure 2 Silicone gastric banding with injection reservoir and calibration tube ..................................... 7Figure 3 Basic gastric bypass .................................................................................................................. 8Figure 4 Roux-en-Y gastric bypass ........................................................................................................ 8Figure 5 Biliopancreatic diversion with distal gastrectomy (Scopinaro) ................................................ 9Figure 6 Biliopancreatic diversion with duodenal switch ..................................................................... 10Table 1 Difference between distal gastrectomy (DG) (Scopinaro) and

duodenal switch (DS) .............................................................................................................. 10Table 2 Outcomes of studies on open (VBG) or laparoscopic (LVBG)

vertical banded gastroplasty ................................................................................................... 14Table 3 Outcomes of studies on open or laparoscopic gastric bypass ................................................. 16Table 4 Outcomes of studies on biliopancreatic diversion ................................................................... 19Table 5 Outcomes of studies on adjustable gastric banding (AGB) .................................................... 21Table 6 Studies comparing biliopancreatic diversion with other open-surgery techniques ................. 25Table 7 Comparative study of open vertical banded gastroplasty ........................................................ 27Table 8 Outcomes of studies comparing VBG with other bariatric-surgery techniques ...................... 27Table 9 Outcomes of the study by Biertho et al. [2003] ...................................................................... 28Table 10 Outcomes of the comparative review of AGB and NAGB ..................................................... 29Table 11 Outcomes of the meta-analysis by Buchwald et al. [2004]

comparing the main types of bariatric surgery ........................................................................ 30Table 12 Outcomes of the meta-analysis by Maggard et al. [2005]

comparing the main types of bariatric surgery ........................................................................ 31Table 13 Type of procedures performed by the members of the International Bariatric

Surgery Registry ...................................................................................................................... 46Table B-1 Laparoscopic vertical banded gastroplasty ............................................................................. 56Table B-2 Comparisons between open and laparoscopic vertical banded gastroplasty ........................... 57Table C-1 Open gastric bypass ................................................................................................................ 58Table C-2 Laparoscopic gastric bypass ................................................................................................... 59Table C-3 Comparisons between open and laparoscopic gastric bypass ................................................ 62Table D-1 Open biliopancreatic diversion ................................................................................................ 66Table D-2 Laparoscopic biliopancreatic diversion ................................................................................... 68Table D-3 Comparisons between open and laparoscopic biliopancreatic diversion ................................ 69Table E-1 Swedish adjustable gastric banding......................................................................................... 70Table E-2 Comparisons between two laparoscopic gastric-banding techniques ..................................... 72Table E-3 Comparisons between the Lap-Band and the Heliogast bands ............................................... 74Table E-4 Laparoscopic adjustable gastric banding ................................................................................. 75Table E-5 Comparisons between open and laparoscopic adjustable gastric banding .............................. 82Table F-1 Comparisons between biliopancreatic diversion and other types of

open procedures....................................................................................................................... 85

xvii

Table F-2 Comparisons between vertical banded gastroplasty and other bariatric-surgery techniques .................................................................................................... 86

Table F-3 Comparisons between Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding ....................................................................................................... 88

Table G-1 Impact of bariatric surgery on obesity co-morbidities ............................................................ 90Table H-1 Description of studies on bariatric surgery with an economic analysis .................................. 92Table I-1 Metropolitan Life Insurance Company table (women with medium frames) ......................... 98Table I-2 Metropolitan Life Insurance Company table (men with medium frames) .............................. 98

1

1 INTRODUCTION

Since 1998, in the wake of a report prepared by the World Health Organization (WHO) from the work of the International Obesity Task Force, obesity has been considered a major public-health problem and has even been declared a “global epidemic.” The WHO even calls it a chronic disease requiring long-term strategies for effective prevention and management: obesity is the result of complex interactions of metabolic, endocrine, genetic, socio-economic, environmental, cultural, psychological and behavioural factors. Obesity causes many diseases, including hypertension, hyperlipidemia, diabetes, some cardiovascular disorders, sleep apnea, osteoarthritis, some cancers, and even death [WHO, 2003].

1.1 DEFINITION OF OBESITYObesity is characterized by excess body fat and is generally defi ned by the body mass index (BMI), which takes into account weight and height. This index is calculated by dividing weight in kilograms by height in metres squared: it is therefore expressed in kilograms per square metre (kg/m2). The term obesity applies when the BMI is greater than or equal to 30 kg/m2. If the BMI is between 25 and 29.9 kg/m2, it is called overweight. According to the International Obesity Task Force, obesity can be divided into three categories: Obese Class I (BMI from 30.0 to 34.9 kg/m2), Obese Class II (from 35.0 to 39.9) and Obese Class III (greater than or equal to 40 kg/m2). Morbid obesity refers to Obese Class III, or to Obese Class II if it is associated with other co-morbidity factors.

1.2 BURDEN OF OBESITY

1.2.1 Prevalence

In the United States, the incidence of obesity (BMI ≥ 30) in the population aged 20 to 74 has

been growing steadily: the rate of obesity rose from 15.1% (age-standardized rate) in the years 1976–1980 to a mean of 23.3% between 1988 and 1994, and to 31.1% in the 1999–2002 period [NCHS, 2004].

In Canada, the percentage of obese people (BMI ≥ 30) in the household population aged 18 and older (excluding pregnant women) in 2004 was estimated to be 23.1%, while it was 13.8% in 1978–1979. These rates are respectively estimated to be 5.1% and 2.3% for people with BMIs between 35 and 39.9 kg/m2, and 2.7% and 0.9% when the BMI is greater than or equal to 40. Although the difference in the obesity rate between men (22.9%) and women (23.2%) is small, it is larger for people with BMIs greater than or equal to 40 kg/m2: 1.6% for men and 3.8% for women. The base data used to calculate these rates were obtained by directly measured height and weight, although an adjustment was necessary to minimize non-response bias (42.5%), (owing to those who did not respond to that part of the survey) [Tjepkema, 2005].

In Québec, according to the data from the 1998 Québec social and health survey, 29.0% (34.1% of men and 23.5% of women) of the population aged 20 to 64 was overweight (BMI ≥ 27 kg/m2). This rate rose to 12.7% (13.5% for men and 11.7% for women) for a BMI ≥ 30 kg/m2, and to 3.0% for a BMI ≥ 35 kg/m2 [Institut de la statistique du Québec, 2001]. Note that these data were collected through a self-administered questionnaire, a method which tends to yield lower obesity rates. In 2004, according to Canadian source data, the obesity rate (BMI ≥ 30 kg/m2) in the Québec household population aged 18 and older was 21.8%, the rate in women (22.7%) being higher than that in men (20.9%) [Tjepkema, 2005]. That publication does not provide more detailed statistics for each class of obesity in Québec.

2

1.2.2 Mortality and economic impact

In the United States, obesity causes a large number of deaths each year, owing both to its complications and to its co-morbidities, although its estimation sparked a major controversy. While a fi rst report by researchers from the Centers for Disease Control and Prevention (CDC) estimated that the number of deaths attributable to overweight and obesity was 365,000 per year [Mokdad et al., 2004], a second report by other CDC researchers yielded a fi gure of 111,909 for obesity alone (BMI ≥ 30) [Flegal et al., 2005]. Even if several factors explain a large part of this difference, it is motivating researchers to develop even more rigorous approaches to estimating mortality attributable to obesity.

Obesity carries an economic burden representing from 5.5% to 7.0% of total health-care spending [Thompson and Wolf, 2001]; it accounted for 27% of the rise in actual spending per person between 1987 and 2001 [Thorpe et al., 2004]. According to a study that examined the relationship between the BMI of people aged 18 to 65 and Medicare spending for these same people at age 65 and older, obese people (30 ≤ BMI < 35) and severely obese people (BMI ≥ 35) generated costs totalling US$9,612 and US$12,342 per person per year respectively, compared with US$6,224 for non-overweight people (18.5 ≤ BMI < 25) [Daviglus et al., 2004].

In Canada, for 1997 alone, direct medical costs attributable to obesity (BMI greater than or equal to 27) in adults were estimated to be $1.8 billion, or 2.4% of total direct medical costs [Birmingham et al., 1999]. A study by the research group Atlantic GPI (Genuine Progress Index), which adopted and refi ned Birmingham’s method, estimated Québec’s direct health-care costs to be $700 million, or 5.8% of the province’s health-care budget (1999–2000 fi scal year). Costs attributable to productivity losses were evaluated as being in excess of $800 million, and the sum of these two estimates could represent nearly 1% of Québec’s gross domestic product [Colman and Dodds,

2000]. Colman also provided the same estimates for seven other provinces.1

1.3 ROLE OF SURGICAL TREATMENT IN THE THERAPEUTIC APPROACH TO OBESITY The therapeutic approach to obesity is multi-faceted and complex. It requires an adapted treatment structure and the availability of a multidisciplinary team.

Management of obesity

Obesity management is based on a minimum of three key measures:

1) intensive patient education aimed at improving food patterns;

2) counselling on the need for regular physical activity; and

3) behavioural approaches designed to help people better regulate the lifestyle habits needing to be modifi ed [Kushner, 2003; NHLBI/NIH, 1998].

Weight-loss objectives must be clearly defi ned with the patient [Snow et al., 2005]. Physicians may suggest drug therapy for obese patients unable to meet their target objectives through diet and physical activity. The use of a pharmacological agent requires a doctor–patient discussion before such treatment is initiated. The side effects of the prescribed medication, the lack of long-term safety data and the modest weight loss associated with it are all points that must be covered [Snow et al., 2005]. According to a recent meta-analysis (April 2005) of the pharmacological treatment of obesity, the mean weight loss achieved, after adjustment for the placebo effect, is less than 5 kg after one year [Li et al., 2005].

Management of morbid obesity

In the latest WHO technical report on the prevention and management of obesity, surgery

1. Colman’s articles are available online: http://www.gpiatlantic.org/publications/health.shtml#obesity.

3

is considered to be the only effective treatment for morbid obesity. This type of surgery is called bariatric surgery (from the Greek word baros, which means weight). Besides its positive effects on weight loss and its acceptable rates of weight-loss maintenance, bariatric surgery is the treatment offering the best cost-effectiveness ratio in the medium term [WHO, 2003; Näslund et al., 2001]. Bariatric surgery encompasses a wide range of techniques, and the effectiveness of each is relatively well established. The choice of one technique over the other is subject to a number of criteria, such as the patient’s clinical and psychological characteristics, the availability of the appropriate infrastructure, the surgeon’s preference and the medical team’s expertise.

The growing “epidemic” of obesity and morbid obesity has prompted the medical body to take greater interest in bariatric surgery and to explore new treatment methods, not only in terms of the techniques themselves but also in terms of the surgical approach, especially laparoscopy. This development has led to a sharp rise in the number of surgical procedures being performed in this fi eld. In the United States, for example, the American Society of Bariatric Surgery (ASBS) reports that this fi gure reached 140,640 in 2004, or more than double the number recorded in 2002

(63,100 procedures) [Colwell, 2005]. This rise can be explained in part by the greater availability of services (e.g., membership in the American Society of Bariatric Surgery doubled between 2000 and 2002 [ASBS, 2001]), but also by a greater reliance on laparoscopy. Moreover, even if the criteria defi ning obesity and the established and generally recognized surgical-candidate profi le have not changed, waiting lists (which may vary according to the surgeon’s expertise) have been growing.

1.4 OBJECTIVEThis is the particular context in which AETMIS proposed to update its information on the effi cacy of the surgical techniques used in the treatment of morbid obesity, which it had already examined in a previous report when it was known as the Conseil d’évaluation des technologies de la santé [CETS, 1998]. In the present update, special attention will be given to laparoscopic techniques, which had barely begun to enter into practice at that time and had therefore not been examined. This report also responds to an assessment request from the Ministère de la Santé et des Services sociaux asking AETMIS to examine the evolution of bariatric surgery and the best patient-care conditions for people with morbid obesity.

4

2 METHODOLOGY

This study is interested in both the reports produced by the different assessment agencies that have dealt with the topic of bariatric surgery and the more recent studies published since the release of the fi rst AETMIS report. A literature search was performed using the major databases: Medline, Cochrane Library, HealthStar (a database that ceased to exist in October 2003) and HTA Database (a health-technology assessment database created jointly by the Centre for Reviews and Dissemination based at the University of York in England, and the INAHTA (International Network for Agencies in Health Technology Assessment). Keywords used were obesity, morbid obesity, surgical treatment, bariatric surgery, gastroplasty, gastric bypass, gastric banding.

The search identifi ed a large number of studies published since 1998. However, given the scarcity of controlled trials, whether randomized or not, and the predo minance of case series, studies were selected by means of a simplifi ed grid containing the following elements:

study design; publication date; number of patients treated; length of follow-up; relevance of clinical and economic outcome

measures.

The main outcome measures for bariatric surgery selected for this analysis were the following (not all were applicable to each of the studies):

Clinical effi cacy: excess weight loss (EWL), defi ned in relation to ideal weight,2 or a decrease in body mass index (BMI);

2. In studies, ideal weight is often based on the tables produced by the Metropolitan Life Insurance Company. It is evaluated according to mean values that take into account height and sex (see Appendix I).

Safety: complications characterized by their time of onset (short, medium or long term) and by their type and severity; Co-morbidity: reduction or not of diseases

associated with obesity; Consumption of health goods or services

or other resources: hospitalization days, mean length of hospital stay, operating time (average length of the surgical procedure) (these criteria can be evaluated as clinical health-status indicators or resource-utilization indicators from an economic perspective), days of absenteeism from work, etc.; Cost effectiveness: resource costs or savings;

cost-effectiveness and cost-utility ratios.

To defi ne the study designs, we used a basic classifi cation system adapted from the one proposed by the Agence Nationale d’Accréditation et d’Évaluation en Santé3 [ANAES, 2001]. This system identifi es a large number of non-comparative studies, regardless of quality:

Randomized comparative study (RC); Non-randomized comparative study (C),

which may be either controlled (CC) or non-controlled (NCC), depending on how much effort was made to ensure that the study groups were as comparable as possible. In addition, the temporal aspect, either prospective (P) or retrospective (R), is indicated by the addition of its corresponding letter: PCC or RCC PNCC or RNCC

Prospective non-comparative study (P); Retrospective non-comparative study (R).

3. On January 1, 2005, this agency was granted additional mandates and renamed the Haute Autorité de Santé.

5

Here are a few salient facts about the articles selected for this analysis.

Most of the published studies deal with surgical techniques that have established effi cacy, or with new approaches, especially laparoscopic procedures. This analysis selected 83 studies published

between January 1998 and April 2005; however, after 2000, most studies deal with adjustable gastric banding. Most of the studies rely on a methodological

design that from the outset is not conducive to achieving the most valid results (non-randomized studies, mostly non-comparative).

Less commonly, some of the studies compare various open or laparoscopic techniques (different types of adjustable bands) or yet again two approaches to the same surgical procedure. The eight randomized studies compare

the laparoscopic and open approaches for the same surgical technique, or different techniques for implanting gastric bands. Two meta-analyses published in 2004 and

2005, respectively, compare the effi cacy of the main procedures. One of them also deals with their impact on the progression of obesity co-morbidities. A single study compares surgical treatment

with non-surgical treatment, and has given rise to several publications dealing with different aspects of the study.

6

3 SURGICAL TECHNIQUES

gastric banding: a fi xed or adjustable band is implanted to form a small-volume gastric reservoir;

hybrid or mixed techniques. These combine gastric restriction with the principle of intestinal malabsorption by creating a bypass system or a diversion system. This group includes: gastric bypass, biliopancreatic diversion.

3.2.1 Gastric-restriction techniques

3.2.1.1 GASTROPLASTY According to the level of the procedure, there are two types of gastroplasty:

Horizontal gastroplasty: Many variants have been proposed, from Mason’s model, which consists in partitioning the stomach horizontally (lesser curvature) by leaving a narrow outlet (stoma) for food passage, to Gomez’s model, which consists in placing a staple line transversely across the proximal part of the stomach and creating a reinforced opening at the level of the greater curvature. Although the sutures were reinforced, the staples often failed and the conduits re-expanded. This type of procedure is no longer performed.

Vertical banded gastroplasty: As described by Mason, vertical banded gastroplasty has the advantage of being easy to perform. This technique consists in creating a small gastric pouch (15–20 ml) that empties into the residual portion of the stomach through a small channel built along the lesser curvature of the stomach and calibrated by means of a polypropylene collar (Figure 1). Patients must not only have good dentition, they must also restrict themselves to eating food in small quantities. Those patients affl icted with frequent vomiting suffer from vitamin and mineral defi ciencies,

3.1 OBJECTIVES OF THE SURGICAL TREATMENT OF MORBID OBESITY Bariatric surgery is based on the principle of restricting food intake (by decreasing the gastric reservoir) or of reducing nutrient absorption (by decreasing the contact time between the food bolus and the digestive juices and bile by shortening the section of the intestine that promotes such contact). The effi cacy of surgical treatment is often measured as a percentage of excess weight loss (EWL) in relation to ideal weight: a technique is considered effective if the EWL is greater than or equal to 50% (based on the criteria defi ned by Reinhold [1982]) [CETS, 1998; Hall et al., 1990]. The outcome is excellent if the EWL is greater than 75%, good if between 50% and 75%, and fair if between 25% and 50%.

Most medical associations recommend that bariatric surgery be reserved for obese patients who meet a certain number of criteria, such as:

body mass index (BMI) greater than or equal to 40, or 35 if associated with other co-morbidity factors; presence of severe co-morbidities; failure of a diet followed for several years; acceptance of long-term (even lifelong)

follow-up and the inherent risks involved in this type of procedure.

3.2 DESCRIPTION OF THE TECHNIQUESThe two most commonly performed bariatric-surgery procedures are:

techniques based on gastric restriction. These decrease food intake by reducing gastric capacity. This group includes: gastroplasty: a pouch or partition is

created by stapling or banding,

7

including iron. Lost weight is frequently regained. Gastric leaks are considered surgical emergencies (risk of septicemia and death).

3.2.1.2 GASTRIC BANDING

Silicone gastric banding has been performed for nearly 20 years. The objective of this procedure is to achieve, by means of a restrictive mechanism, a reduction in dietary intake by creating a small gastric pouch. The gastric fi bres of this pouch stretch more quickly, which stimulates the vagus nerve fi bres and triggers satiety refl exes. In 1987, a silicon part was added to this system, which helps adjust and calibrate the collar that controls the speed of food passage from the upper gastric pouch to the lower portion of the stomach (hour-glass shape). The band can be adjusted by injecting liquid into a subcutaneous reservoir (Figure 2).

This procedure is relatively easy to perform and also reversible, which explains why it is used so frequently. There are a few types of adjustable gastric bands, which basically have differing elasticity and closure systems. The main trademarks are Lap-Band, SAGB and Heliogast. Only the Lap-Band is commercially available in Canada.

Improvements in surgical techniques (type, fi xation method and band placement) and the laparoscopic approach have both contributed to signifi cantly reducing complications. Of these, dilatation of the newly formed gastric pouch, whether or not associated with band slippage, remains the most frequent (5–20% of cases). Adjustable gastric banding is the bariatric-surgery technique that is most often performed laparoscopically.

FIGURE 1 FIGURE 2

Vertical banded gastroplasty Silicone gastric band with injection reservoir and calibration tube

8

3.2.2 Gastric bypass

The key objective of gastric bypass is to reduce the digestion of absorbed nutrients. This procedure induces marked weight loss but is associated with complications that are more or less severe, depending on the technique used. Techniques combining gastric restriction and malabsorption are used more frequently with morbidly obese patients with BMIs greater than 50.

3.2.2.1 GASTRIC-BYPASS PROCEDURES

Since the 1960s, several modifi cations have been made to Mason’s gastric bypass (Figure 3), which consisted in creating a small proximal gastric pouch by surgically dividing the stomach and its duodenal opening (gastric bypass with retrocolic loop). Other gastric-bypass models consist in creating a reservoir by stapling. This type of procedure leads to leaks and the dumping syndrome (an adverse event that

occurs with all hybrid techniques that include gastric bypass).

3.2.2.2 ROUX-EN-Y GASTRIC BYPASS

Now considered the gold standard in bariatric surgery, this technique consists in creating a small proximal gastric pouch anastomosed to a segment of the jejunum. This system is shaped like a Y; hence the name Roux-en-Y gastric bypass (RYGB). This technique has several variants, one of which involves creating a small pouch with a line of staples (Figure 4). Different RYGB procedures are performed, including short-limb (50–100 cm) Roux-en-Y gastric bypass and long-limb Roux-en-Y gastric bypass, considered by some authors to be biliopancreatic diversions. The main complications associated with RYGB are metabolic, and they require patients to take supplemental vitamins (especially vitamin B12) and minerals (calcium and iron).

FIGURE 3 FIGURE 4

Basic gastric bypass Roux-en-Y gastric bypass

9

3.2.2.3 BILIOPANCREATIC DIVERSION

3.2.2.3.1 Scopinaro’s biliopancreatic diversion

Scopinaro et al. [2000] showed that it was possible to decrease nutrient absorption by shortening the intestine and to reduce fat (lipids) absorption by diverting bile juices and decreasing the contact between food and enzymes. Scopinaro’s biliopancreatic diversion shares many similarities with RYGB, but differs in that it involves a complete resection of the lower, or distal, portion of the stomach (Figure 5). The Scopinaro procedure is in fact a biliopancreatic diversion combined with a distal gastrectomy (BPD-DG).

3.2.2.3.2 Biliopancreatic diversion with duodenal switch

Unlike Scopinaro’s biliopancreatic diversion with distal gastrectomy, this technique applies a duodenal switch with an end-to-end duodeno-ileal anastomosis (Figure 6). In theory,

biliopancreatic diversion with duodenal switch (BPD-DS) has the advantage of permitting near-normal functioning of the stomach and avoiding a gastro-enteric anastomosis [Hess and Hess, 1998]. This type of procedure conserves normal vagal innervation (control of the satiety centre) and preserves the antropyloric junction, which plays a role in triggering the secretion of secretin (Table 1). A duodenal switch involves resecting the gastric fundus, helping to reduce the secretion of hydrochloric acid. Maintaining both the integrity of this junction and a small portion of the duodenum (a few centimetres of the fi rst duodenal loop) seems to prevent gastroduodenal ulcers, perforations and the dumping syndrome [DeMeester et al., 1987]. In 1992 Marceau et al., from the Hôpital Laval in Quebec City, modifi ed this technique by eliminating plication in creating the anastomosis and by replacing it with an end-to-end anastomosis [Baltasar et al., 1995; Marceau and Biron, 1993]. Post-operative complications are most often metabolic, and supplemental vitamins and calcium are required.

FIGURE 5

Biliopancreatic diversion with distal gastrectomy (Scopinaro)

10

FIGURE 6

Biliopancreatic diversion with duodenal switch

TABLE 1

Difference between distal gastrectomy (DG) (Scopinaro) and duodenal switch (DS)

DG (SCOPINARO) DS*

Insertion Stomach/ileum Duodenum/ileum

Common limb 50 cm 100 cm

Vagal innervation Not preserved Preserved

* In 1992 Marceau abandoned plication for an end-to-end anastomosis.

3.2.3 Laparoscopic techniques

In theory, laparoscopic surgery techniques have the advantages of shorter recovery times and lower peri-operative and post-operative complications. Other than the surgical approach itself, laparoscopic techniques are generally identical to open-surgery techniques. While the most commonly used laparoscopic techniques since 1990 are based on gastric restriction, procedures targeting malabsorption are recent and still infrequent.

Vertical banded gastroplasty (VBG) and adjustable gastric banding (AGB) are the

most frequently performed laparoscopic procedures. The LVBG4 technique requires considerable expertise in both bariatric surgery and laparoscopy, and it is increasingly being replaced by LAGB, a technique that has been greatly improved in recent years.

Gastric bypass (LGB) is also one of the bariatric surgeries most frequently performed laparoscopically. It is therefore expected that LRYGB performed by experienced surgeons will become a therapeutic option to consider.

4. LVBG: laparoscopic VBG. The same type of abbreviation is used for the other laparoscopic techniques: LAGB, LDG, LRYGB and LBPD.

11

Laparoscopic biliopancreatic diversion (LBPD) is used only in exceptional cases because of its complexity and recent entry into the arsenal of bariatric surgery.

3.2.4 Bariatric surgery with hand-assisted laparoscopy

This technique combines two surgical approaches. First, a small incision (6–8 cm) is made to the abdomen. This incision, which

is large enough to fi t a hand, allows the surgeon to palpate the organs and makes it easier to mobilize them (e.g., the colon). The essential part of the procedure is then done laparoscopically (resection, ligature, etc.). This novel approach remains limited to some centres or is used as a training tool before surgeons proceed to exclusively laparoscopic procedures [DeMaria et al., 2002b; Bleier et al., 2000; Naitoh et al., 1999; Memon and Fitzgibbons, 1998; Watson and Game, 1997].

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4 STUDY OUTCOMES

4.1 SURGICAL VS NON-SURGICAL TREATMENT OF MORBID OBESITY

As part of the major prospective SOS study, Ågren et al. [2002b] compared patients who had undergone open surgery (vertical banded gastroplasty, gastric banding, gastric bypass) with patients who had followed medical (non-surgical) therapy. The SOS study was initially designed to compare, over a 20-year period, 2010 surgically treated obese patients and 2037 matched patients who were offered conventional treatment in primary-care centres. Control subjects were matched according to 18 basic anthropometric variables or to variables linked to risk factors for morbidity and mortality. The researchers fi nally studied the fi rst 962 consecutive obese patients (BMI > 34 kg/m2 for men and > 38 kg/m2 for women) aged 37 to 60. These patients were recruited between 1987 and 1991, and were followed for at least six years. The study examined therapeutic effectiveness in relation to weight loss and hospital costs associated with each of the treatment options: bariatric surgery vs services commonly offered to obese patients in primary-care centres (conventional treatment). No specifi c information was given on the treatments actually received by the “conventional treatment” group. Comparisons of hospital costs will be covered in Chapter 5 on economic outcomes.

Results show that, at one year, the surgical patients had lost more weight (mean weight loss of 25.1 ± 10.1% for 450 patients) than those in the conventionally treated group (mean weight loss of 0.7 ± 6.5% for 425 patients). This major benefi t of bariatric surgery was maintained after six years (mean weight loss of 16.7 ± 11.8% for 401 patients, compared with a mean weight gain of 0.9 ± 10.1% for 344 non-surgical patients).

Virtually all the studies on bariatric surgery are of adult subjects after the failure of conventional treatment (diet and medical therapy) and after review of the patient’s psychological profi le. Until recently, bariatric surgery for adolescents (ages 11 to 17) with morbid obesity was used only in exceptional circumstances [Abu-Abeid et al., 2003]. A recent meta-analysis of the surgical treatment of morbid obesity identifi ed 12 case series with a combined total of 172 adolescents. However, insuffi cient data and a lack of comparators do not permit valid conclusions to be drawn [Maggard et al., 2005].

Among all the articles identifi ed and selected for the present assessment, a single study compared the effi cacy of surgical vs non-surgical treatment for patients with morbid obesity: the Swedish Obese Subjects (SOS) Intervention Study [Sjöström et al., 2004; Ågren et al., 2002b]. The outcomes of this comparative study, which is of good quality although non-randomized, confi rm that surgery has a role to play in the management of morbid obesity. This study includes a clinical component and an economic component. The economic component will be covered in Chapter 5.

The studies dealing with the impact of bariatric surgery on obesity co-morbidities will be analyzed in section 4.4.

This section begins by examining study outcomes by type of procedure and then deals with comparisons of the effi cacy of different techniques. Given that the techniques used are the same, whether open or laparoscopic, the effi cacy outcomes will not be presented separately by approach. However, special attention will be given to post-operative length of hospital stay and to some complications that do depend on the type of surgical approach taken.

13

A more recent article by Sjöström et al. [2004] on the same study indicates that weight loss measured at 10 years was roughly the same at 6 years (16.1% vs 16.7%). The control group had had a mean weight gain of 1.6% at 10 years, and the difference between the two groups is statistically signifi cant (p < 0.001). The data were based on 641 surgical patients and 627 controls. It should be mentioned that the lost to follow-up rates were high, 24.7% and 26.4% respectively. Finally, the post-operative mortality rate among the 2010 surgical patients remained very low (0.25%).

In terms of weight reduction alone, the SOS study shows that bariatric surgery is more effective than non-surgical treatment, and the difference is statistically signifi cant. Even if the preliminary outcomes (measured at one or two years) are higher, the benefi ts achieved in terms of weight loss are nevertheless sustained. In addition, as will be seen in section 4.4 on the impact of bariatric surgery on co-morbidities and in Chapter 5 on the economic component, the benefi ts of bariatric surgery go beyond weight loss.

In their summary report of a retrospective comparative study recently conducted in Québec, Christou et al. [2004] present their comparative outcomes resulting from a 20-year (1983–2002) follow-up of 6781 patients with morbid obesity (1035 surgical patients and 5746 patients matched by age and sex but not surgically treated). The mean initial BMI was 50 kg/m2 (range, 36–98). The two cohorts were followed up for a maximum of fi ve years, and the data were extracted from provincial health-insurance databases on hospitalizations, medical services and medications. Of the surgical patients, 194 underwent vertical banded gastroplasty (VBG), 68 then underwent Roux-en-Y gastric bypass (RYGB), and 841 underwent isolated RYGB (21 of which were performed laparoscopically). Seven different surgeons affi liated with the same university health centre took part in the procedures during the 16.4 study years.

There were no signifi cant differences between the two groups in terms of age, sex and length of follow-up. Overall, after a mean follow-up of 5.3 years, excess weight loss (EWL) after bariatric surgery was 67.1% (standard deviation: 23.7%; p < 0.001). This reduction tended to persist until 16 years after surgery. Nevertheless, the follow-up rate, which had stayed relatively stable for 11 years, dropped dramatically thereafter. According to Reinhold’s criteria (EWL ≥ 50%), the authors consider the procedure successful for 83% of the morbidly obese patients and for 73% of the super-obese patients (BMI > 50).

4.2 EFFICACY OF THE DIFFERENT SURGICAL PROCEDURES

4.2.1 By type of procedure

4.2.1.1 VERTICAL BANDED GASTROPLASTY

The outcomes (excess weight loss) of the studies of vertical banded gastroplasty (VBG) vary according to the settings and the follow-up periods under consideration; these studies are only case series (except for the randomized trial by Dávila-Cervantes comparing open vs laparoscopic VBG (Table 2).

A prospective study of 60 patients indicates that the BMI, initially 44.4 kg/m2, dropped to 37 kg/m2 at 36 months, and that the outcomes were practically identical, whether the gastroplasty was performed as an open procedure or laparoscopically [Näslund et al., 1999] (Table B-1, Appendix B). In two studies, weight loss was maintained in patients who were followed up for fi ve years [Hell and Miller, 2000; Capella and Capella, 1996]. With the laparoscopic approach, the mean hospital stay is generally from three to four days, and this approach does not usually lead to the complications that arise from open surgery (Tables B-1 and B-2, Appendix B).

14

TABLE 2

Outcomes of studies on open (VBG) or laparoscopic (LVBG) vertical banded gastroplasty*

AUTHORS AND YEAR (STUDY DESIGN)

TYPE OF PROCEDURE

BMI(kg/m2)

EWL

Capella and Capella, 1996 (RNCC)

VBG (n = 328) 52 ± 9 30–42 months: 48 ± 23%54–66 months: 47 ± 23%

Alle et al., 1998 (R)

LVBG (n = 261) 43.3 18 months: 75%

Salval et al., 1999 (R)

LVBG (n = 87) 43.8 18 months: 75%

Toppino et al., 1999 (R)

LVBG (n = 170) 43.9 36 months: 61%

Bajardi et al., 2000 (RNCC)

VBG (n = 93) 48.7 (37–65.6) 24 months: 48%

Hell and Miller, 2000 (PNCC)

VBG (n = 101) 46.9 ± 9.0 2 years: 61% (n = 98)5 years: 69% (n = 15)

Hell et al., 2000 (PCC)

VBG (n = 30) 46.9 ± 9.9 40.1 ± 8.3 months: 0–24% (n = 1) 50–74% (n = 15) 25–49% (n = 12) 75–100% (n = 2)

Dávila-Cervantes et al., 2002 (CR) VBG (n = 14)

LVBG (n = 16)43 (37–50)45 (38–50)

12 months (NS): 55% (30–88) 47% (22–97)

* See appendix for detailed data in Tables B-1, B-2, F-1 and F-2.

PCC: prospective, controlled comparative study; PNCC: prospective, non-controlled comparative study; RNCC: retrospective, non-controlled comparative study; RC: randomized comparative study; R: retrospective non-comparative study; n: number of patients; NS: non-signifi cant difference.

patients enrolled in this study greatly reduces the clinical bearing of these outcomes (Table B-2, Appendix B).

4.2.1.2 ROUX-EN-Y GASTRIC BYPASS AND VARIANTS

Analysis of the outcomes in the different studies on this topic confi rms the effi cacy of Roux-en-Y gastric bypass (RYGB), evaluated according to the criteria of stable weight loss and a low complication rate (Table 3). In clinical practice, RYGB is now considered the gold standard of open bariatric-surgery techniques. The EWL achieved generally exceeds 50% and even nears 80% two years after surgery, and according to studies with longer follow-up periods, this weight loss seems to be maintained [Hell et al.,

The article on the most recent randomized study comparing open vertical banded gastroplasty (VBG) with the laparoscopic approach (LVBG) provides outcomes for a limited number of patients (14 for the open-surgery group and 16 for the laparoscopy group) for a relatively short follow-up period. At one year, there was no signifi cant difference in terms of EWL: 55% for the VBG group and 47% for the LVBG group (Table 2). The mean hospital stay was similar for both groups (four days). Patients in the LVBG group required fewer analgesics on the fi rst post-operative day, stopped taking them sooner (two days vs three days for the VBG group) and returned to their normal activities sooner than those in the VBG group [Dávila-Cervantes et al., 2002]. Nevertheless, the limited number of

15

2000; Wittgrove and Clark, 2000; Rabkin, 1998; Capella and Capella, 1996]. The mean hospital stay associated with this procedure is from four to six days, according to the two studies providing that fi gure [Westling et al., 2002; Fobi et al., 1998]. The differences in weight-loss outcomes largely depend on the patients’ characteristics and on the surgical team’s learning curve. In 57% of the super-obese patients studied by MacLean et al. [2000], the EWL was greater than 50% (with improved quality of life in most cases), while another team, which had combined VBG with RYGB, reported the same outcome in 97.6% of the patients in that particular group [Capella and Capella, 2002].

A randomized study on gastric bypass compared the laparoscopic approach with open surgery. A total of 104 patients were randomly assigned to open surgery (51 subjects) or to laparoscopy (53). There were no signifi cant differences in terms of male-female ratio, age, initial weight and BMI (see Table C-3 in Appendix C). The authors found no signifi cant difference between the two groups after a mean follow-up of 23 months, but the results pertaining to changes in BMI are presented only graphically. The patients assigned to laparoscopy had shorter operating times (186.4 vs 201.7 minutes: p < 0.05) and hospital stays (5.2 vs 7.9 days: p < 0.05). Early complications (less than 30 days post-operatively) rose to 22.6% in the laparoscopy group and 29.4% in the open-surgery group. Although the difference is not signifi cant, it is worth mentioning that the two groups experienced different types of

complications and that one death occurred in the open-surgery group during a re-operation. The conventionally treated patients had more late complications (24%, mainly post-operative abdominal-wall hernias) than those who had been operated laparoscopically (11%: p < 0.05). Two deaths were nevertheless recorded in the laparoscopy group, one intra-operatively and the other presumably due to pulmonary embolism [Luján et al., 2004].

Despite the major advantages that the laparoscopic approach may offer, the authors conclude that it has a more complex learning curve and that the risk of post-operative complications is greater in the early stages of the curve.

For laparoscopic gastric-bypass procedures, the outcomes expressed as EWL are rather similar, varying from 68.8% to 82% at 12 months, depending on the study (Table 3). This similarity was also observed in a study with a longer follow-up period [Wittgrove and Clark, 2000]. Hospital stays are generally shorter than with conventional GBPs and RYGBs (1.6–4 days) (Tables C-2, C-3 and F-3, Appendices C and F). One study, which did not use EWL as an outcome measure, reported a mean initial weight loss of 35% and a decrease in BMI from 51.5 to 32 kg/m2, at 18 months of follow-up. This study included 195 patients: 159 underwent laparoscopic procedures and 36, open surgery [Brody, 2004] (Table C-2, Appendix C). Results of the same order had previously been observed in a series of 52 patients, the mean BMI having dropped from 55 to 34 kg/m2 [Gagner et al., 1999] (Table C-2, Appendix C).

16

TABLE 3

Outcomes of studies on open or laparoscopic gastric bypass*

AUTHORS AND YEAR (STUDY DESIGN)

TYPE OF PROCEDURE

BMI(kg/m2)

EWL

Capella and Capella,1996 (RNCC)

VBG-RYGB (n = 560) 52 ± 9 30–42 months: 70 ± 19%54–66 months: 62 ± 17%

Fobi et al., 1998 (R)

RYGB (n = 944) 46 24 months (mean): 80%

Rabkin, 1998 (RNCC)

RYGB (n = 138) 49 24 months: 74%48 months: 63%

Wittgrove and Clark, 2000 (R)

LRYGB (n = 500) Unspecifi ed 54 months: 73%


RYGB (n = 30) 45.2 ± 8.2 60 ± 8.1 months: 0–24% (n = 0) 25–49% (n = 2) 50–74% (n = 6) 75–100% (n = 22)

Higa et al., 2000 (R)

LGBP (n = 400) 46 12 months: 69%

MacLean et al., 2000 (R)

RYGB (n = 243) 49 66 ± 18 months: ≥ 50%(93% of obese or morbidly obese patients and 57% of super-obese patients)

Schauer et al., 2000 (P)

LRYGB (n = 275) 48 30 months: 77%

Nguyen et al., 2001 (RC) RYGB (n = 76)

LRYGB (n = 79)48.4 ± 5.447.6 ± 4.7

6 months (p = 0.01): 1 year (p = 0.07):45 ± 12% 62 ± 14%54 ± 14% 68 ± 15%

Capella and Capella,2002 (R)

VBG-RYGB (n = 652) 50 (38–86)(42% of super-obese patients)

5 years:77 ± 17% (all patients)74 ± 15% (super-obese patients)

DeMaria et al., 2002b (R)

LGBP (n = 281)Hand-assisted LGB (n = 25)

48.1 ± 6.5

(40.3–71) 12 months: 70 ± 15%

Frezza et al., 2002 (R)

LRYGB (n = 238) 48 (39–67.9) 12 months: 68.8%

Biertho et al., 2003 (RNCC)

LRYGB (n = 456) 49.4 ± 8.3 6 months: 51.6% (88% of patients)12 months: 67.0% (57%)18 months: 74.6% (37%)

Courcoulas et al., 2003a (PCC) GBP (n = 80)

LGBP (n = 80)4644

6 months (p < 0.05): 1 year (NS):45% 64.9%52.6% 69.2%

Stoopen-Margain et al., 2004 (P)

LRYGB (n = 100) 50 ± 9(33% of patients with BMIs > 50)

6 months: 47 ± 2% (n = 82)12 months: 62 ± 4% (n = 70) 18 months: 66 ± 5% (n = 63) 24 months: 67 ± 8% (n = 35)

* See appendix for detailed data in Tables C-1, C-2, C-3, F-1, F-2 and F-3.P: prospective non-comparative study; PCC: Prospective, controlled, non-randomized comparative study; R: restrospective non-comparative study; RC: randomized comparative study; RNCC: retrospective, non-controlled, non-randomized comparative study; n: number of patients; NS: non-signifi cant difference.

17

Two randomized studies compared open vs laparoscopic gastric-bypass procedures. The fi rst presented outcomes related to excess weight loss for 76 patients who had undergone open RYGB and for 79 patients who had undergone LRYGB over a mean follow-up of 9.6 months (1–23 months) [Nguyen et al., 2001]. In terms of excess weight loss measured at one year, laparoscopy tended to be more effective, although the difference is not signifi cant (68 ± 15% vs 62 ± 14% for the open-surgery group; p = 0.07) (Table 3). Even though operating times were longer in the LRYGB group, patients lost less blood and required less intensive care than those in the open RYBG group (signifi cant differences). The mean length of hospital stay and the return to normal activities were shorter with laparoscopy: 3 hospitalization days and 8.4 recovery days (vs 4 hospitalization days and 17.7 recovery days with open surgery). From a quality of life perspective, even if the SF-365 scores at one month were better for the LRYGB patients, at three months they were similar to those in the group assigned to open surgery (Table C-3, Appendix C).

These outcomes are supported by the other study, which was conducted by Westling and Gustavsson [2001] (since these authors do not provide their outcomes in relation to EWL, the details of this study are presented in Table C-3 in Appendix C). The outcome differences between the two groups are not statistically signifi cant: at one year, the BMI fell from 41 to 27 ± 4 kg/m2 in the group of 30 LRYGB patients, and from 43.9 to 30.6 ± 4 kg/m2 in the open-surgery group (21 patients). The mean length of hospital stay and recovery times were shorter in the laparoscopy group (n = 30) (signifi cant differences: p < 0.025). Weight loss remained

5. The SF-36 (36-Item Short-Form Health Survey) is a self-administered questionnaire that serves to measure quality of life (QoL) as related to health. It contains 36 questions that evaluate 8 health domains: physical functioning, social functioning, bodily pain, general health perceptions, vitality, limitations as a consequence of mental or physical health, mental health, and perceived changes in general health.

relatively identical at one year in both groups. However, in the laparoscopy group, the conversion rate to an open procedure was high (23%, while it was 2.5% in the study by Nguyen et al.). The authors suggest that this rate could be appreciably reduced by stricter patient selection.

Another study, which was non-randomized, compared the open and laparoscopic approaches to gastric bypass in two groups of 80 patients matched by age, sex, pre-operative BMI and number of co-morbidities, with a 12-month follow-up. Even if the laparoscopic approach led to greater weight loss after the fi rst six months, with an EWL of 52.6% in the LRYGB group and 45% in the RYGB group (p < 0.05), this difference had decreased within one year and was no longer statistically signifi cant (69.2% vs 64.9% respectively) (Table 3). The differences in the major and minor complication rates are not signifi cant. The preliminary quality-of-life analysis based on an SF-36 survey indicates similar positive results close to healthy-population normative data: all the surgical subjects appreciated the benefi ts of improved quality of life after their operations, and there was no signifi cant difference between the two groups. The authors conclude that the two surgical approaches to gastric bypass seem equally effective in reducing weight and complications [Courcoulas et al., 2003a] (Table C-3, Appendix C).

Other more recent case series [Brody, 2004; Dresel et al., 2004; Stoopen-Margain et al., 2004] corroborate the effi cacy and benefi ts of LRYGB in terms of decreasing hospital stays and post-operative complications (Table 3 and Table C-2, Appendix C). Brody reports a decrease in the mean BMI from 51.5 to 32.0 kg/m2 in 195 patients after 18 months of follow-up. Stoopen-Margain et al., who analyzed the outcomes for 100 consecutive patients treated with LRYGB, reported an excess weight loss identical to that obtained with open surgery, 66 ± 5% at 18 months (n = 63) and 67 ± 8% at 24 months (n = 35), along with a signifi cant improvement in the patients’ health status

18

(diabetes and hypertension). They nevertheless emphasize that long-term follow-up remains necessary. Dresel et al., after having compared operating times, mean length of stay and complications in 60 obese patients (BMI < 50) and 60 super-obese patients (BMI > 50), observed no signifi cant differences. They conclude that the laparoscopic approach can safely be used with super-obese patients. They do not provide weight-loss outcomes, however.

As for hand-assisted RYGB procedures, the outcomes of the prospective, randomized trial conducted by Sundbom and Gustavsson [2004] are comparable to those documented in patients who underwent open RYGB: the mean BMI fell from 44 to 29 kg/m2 and from 45 to 30 kg/m2 respectively, with similar post-operative data. The authors conclude that there is no advantage to hand-assisted procedures. They confi rm the previous outcomes published in 2002 by DeMaria et al. [2002a].

4.2.1.3 BILIOPANCREATIC DIVERSION (BPD)

Even if biliopancreatic diversions with duodenal switch (BPD-DS) have been performed for more than 20 years, there is still only a limited number of studies providing detailed results. The CETS report [1998] had previously examined BPD-DS, which had been raising questions in Québec at that time. In selected patients who had undergone a BPD-DS, the EWL seemed to remain above 70% four or more years after surgery [Marceau et al., 1998; Rabkin, 1998], and even up to eight years in some cases [Hess and Hess, 1998] (Table 4 and Tables D-1 and F-1, Appendices D and F). Marceau et al. [1998] also compared BPD-DS with BPD-DG and attempted to minimize the differences in the follow-up periods by analyzing the subgroup of patients on whom they had operated during the year before the adoption of BPD-DS and those who had had this surgery during the year

after its adoption. The difference in the EWL is signifi cant, in favour of BPD-DS (70 ± 21% for a mean follow-up of 74 ± 4 months, vs 63 ± 21% for a follow-up of 85 ± 3 months) (Table F-1, Appendix F).

In a study published in 2000, Scopinaro et al. presented the outcomes of 23 years of experience with 2316 patients treated with BPD-DG (with different surgical variants). Data show a permanent decrease of about 75% in the initial excess weight of patients followed up for long periods (EWL = 75 ± 15% at 6 years in 1054 patients, and 76 ± 15% at 10 years in 381 patients) (Table 4), with an operative mortality rate of less than 0.5%. The late-complication rates remained less than 5% (Table D-1, Appendix D). The authors found improvements in the patients’ clinical and biological characteristics. They conclude that BPD-DG, when correctly performed by a surgeon with a sound knowledge of its mechanisms of action, is an effective and safe procedure.

More recently, Biron et al. [2004] presented the outcomes that they obtained through 20 years of performing BPDs (this retrospective study is not included in Table 4 because the outcomes are not expressed as EWL; details are presented in Table D-1 in Appendix D). From February 1984 to December 2002, 1271 consecutive patients underwent BPD, and 997 of them were enrolled in the study. After a follow-up of 7.9 ± 4.2 years, the BMI had dropped from 48.4 ± 9.4 to 31.3 ± 6.5 kg/m2, but in 36% of patients, the procedure was considered a failure: at the end of follow-up, 10% of patients had BMIs greater than or equal to 40 kg/m2, and the BMIs of the remaining 26% were between 35 and 40. The authors explain these results by the fact that the most obese patients lose relatively less weight and tend to regain lost weight more quickly.

19

TABLE 4

Outcomes of studies on biliopancreatic diversion*

AUTHORS AND YEAR

(STUDY DESIGN)

TYPE OF PROCEDURE

BMI(kg/m2)

EWL

Hess and Hess, 1998 (R)

BPD-DS (n = 440) 50 From 9 to 108 months: 80% of patients had a minimum EWL of 80%.

Marceau et al., 1998 (RNCC)

BPD-DG (n = 252)BPD-DS (n = 465)

46 ± 9 (n = 233)47 ± 9 (n = 457)

100 ± 20 months: 61 ± 22%

51 ± 25 months: 73 ± 21% Rabkin, 1998 (RNCC) BPD-DG (n = 32)

BPD-DS (n = 105)4549

24 months: 48 months (NS):69% 73% 78% 73%


BPD-DS (n = 142) 50 (35–81) 2 years: 60%

Ren et al., 2000 (P)

LBPD-DS (n = 40) 60 (42–85) 6 months: 46 ± 2%9 months: 58 ± 3%

Scopinaro et al., 2000 (R)

BPD-DG (different variants) (n = 2316)

47 (29–87) 6 years: 75 ± 15% (n = 1054)10 years: 76 ± 15% (n = 381)

Kim et al.,2003 (RNCC) BPD-DS (n = 28)

LBPD-DS (n = 26)68.8 ± 10.166 ± 7.5

6 months (NS): 9 months (NS): 1 year (NS):44.3 ± 5.7% 48.7 ± 4.1% 56.8 ± 26.3% 56.9 ± 20.4% 68.1 ± 26.5% 76.7 ± 19.7%

Marinari et al.,2004 (R)

BPD-AHS (n = 858) 47 ± 7 2 years: 67 ± 18% (n = 800) 4 years: 67 ± 18% (n = 738) 6 years: 68 ± 18% (n = 659) 8 years: 69 ± 18% (n = 532) 10 years: 68 ± 18% (n = 334) 12 years: 66 ± 18% (n = 131) 14 years: 69 ± 15% (n = 60)

* See appendix for detailed data in Tables D-1, D-2, D-3 and F-1.

P: prospective non-comparative study; R: retrospective non-comparative study; RNCC: retrospective, non-controlled, non-randomized comparative study; n: number of patients; NS: non-signifi cant difference.

weight loss remained between 66% and 69% for 14 years on average, but the difference in the mean excess weight loss between the two groups was not signifi cant (BPD-AHS: 70.5 ± 23%; BPD-AHS-AHAL: 64.7 ± 17%). The re-operation rate was nevertheless higher (8.6%) in the BPD-AHS group (1.1% for the BPD-AHS-AHAL group; p < 0.001). The reduction of surgical revisions and improvement of quality of life (QoL score), and even resolution of certain co-morbidities documented among the patients in the BPD-AHS-AHAL group increased the success rate (sum of excellent, very good

For their part, Marinari et al. [2004] analyzed the results of 858 biliopancreatic diversions performed between June 1984 and December 1998 with creation of an ad hoc stomach (AHS) (the volume is adapted to patient characteristics) and a 50-cm common limb. Patients operated on between June 1984 and August 1992 received a 200-cm alimentary limb (BPD-AHS), while those operated on from September 1992 onwards received an ad hoc alimentary limb (AHAL) that varied in length depending on individual characteristics (BPD-AHS-AHAL). As shown in Table 4, excess

20

and good BAROS6 results) to 92% (83% for the BPD-AHS group). The complication and mortality rates with BPD did not seem higher than those recorded for the other procedures (Table D-1, Appendix D). It is nevertheless worth pointing out that these outcomes were obtained by teams who were highly experienced, if not specialized, in this type of procedure.

Studies on laparoscopic biliopancreatic diversion are rare (fi ve studies: Kim et al., 2003; Baltasar et al., 2002; Scopinaro et al., 2002; Paiva et al., 2001; Ren et al., 2000), their results are most often incomplete, their enrollments are limited and their follow-up is too short or unspecifi ed (see Table 4 and Tables D-2 and D-3 in Appendix D for outcomes not expressed as EWL). In a case series presenting more complete data on 40 BPD-DS patients at 9 months, the mean excess weight loss was 58%, and the complication rate was 17.5% [Ren et al., 2000]. Hospital stays ranged from four to eight days and were shorter than those following open surgery.

A single study retrospectively compared open biliopancreatic diversion (BPD-DS) and laparoscopic biliopancreatic diversion (LBPD-DS) in super-obese patients (BMI > 60 kg/m2). Outcomes at one year of follow-up tend to show that laparoscopy is more effi cacious and has a greater incidence of post-operative complications, but these differences are not signifi cant (Table D-3, Appendix D). While recognizing the limitations of their study design, the authors conclude that, even if LBPD is associated with a steep learning curve, this technique seems to be effective and safe for super-obese patients. Nevertheless, both approaches lead to appreciable mortality and

6. BAROS (Bariatric Analysis and Reporting Outcome System): This system is based on assigning scores to quality of life (QoL), EWL, complications and improvements in co-morbidities (the scoring key is presented in Appendix J).

morbidity rates, and further studies are needed to determine the best treatment for this particular population [Kim et al., 2003].

4.2.1.4 GASTRIC BANDING

Adjustable gastric banding (AGB) is a technique most often performed laparoscopically. In a recent prospective study, Steffen et al. [2003] published fi ve-year follow-up outcomes for 824 patients who had undergone laparoscopic Swedish adjustable gastric banding (SAGB). This study is characterized by a rather long follow-up period (fi ve years for 97% of patients), complete data on complications (time of onset and type) and a clear defi nition of the effi cacy outcome measure used (insuffi cient weight loss is defi ned as an EWL of less than 50% with no weight loss for three months or a 10% regain of lost weight, with the EWL being calculated from the Metropolitan Life Insurance tables [Appendix I]). Outcomes show that 82.9% of the patients lost more than 50% of their excess weight and that their quality of life (based on the BAROS score) varied according to the presence or absence of co-morbidities. At three years, the BAROS score was good, very good or excellent in 29 of the 40 patients who did not have any co-morbidities (72.5%) and in 157 of the 177 patients who did (88.7%). The authors report a mortality rate of 0.4% (three deaths) and a conversion rate of 5.2%. The long-term complication rate was 23.2% (191 patients), and 135 complications were related to the gastric band (Table E-1, Appendix E).

In conclusion, these study outcomes show that LAGB is effective in reducing excess weight, as long as fi ve years post-operatively (Table 5), with complication rates that the authors qualify as acceptable.

21

TABLE 5

Outcomes of studies on adjustable gastric banding (AGB)*

AUTHORS AND YEAR

(STUDY DESIGN)

TYPE OF PROCEDURE

BMI(kg/m2)

EWL

Belachew et al., 1998 (R)

LAGB (n = 550) 43 5 years: 50%

Dargent, 1999 (R)

LAGB (n = 500) 43 (36–60) 6 months: 45% (n = 443)1 year: 56% (n = 270)2 years: 65% (n = 96)3 years: 64% (n = 19)

Fielding et al., 1999 (R)

LAGB (n = 335) 46.7 (34–86) 12 months: 52% (n = 125)18 months: 62% (n = 58)

O’Brien et al., 1999 (P)

LAGB (Lap-Band)

(n = 277 out of 302 patients selected prospectively)

44.5 ± 6 1 year: 51.0 ± 17% (n = 120)2 years: 58.3 ± 20% (n = 43) 3 years: 61.6 ± 2% (n = 25)4 years: 68.2 ± 21% (n = 12)

Zimmermann et al.,1999 (R)

LAGB (n = 864)

LSAGB (n = 33)

42 (35–72) 6 months: 32% (n = 676)12 months: 40% (n = 233)18 months: 46.5% (n = 89)24 months: 39% (n = 47)


LSAGB (n = 30) 46.9 ± 7.8 Follow-up of 39.7 ± 7.6 months:0–24% (n = 1)25–49% (n = 13)50–74% (n = 15) 75–100% (n = 1)

Hell and Miller,2000 (PNCC)

LSAGB (n = 99) 46.9 ± 7.8 2 years: 59% (n = 97)5 years: 71% (n = 16)

DeMaria et al.,2001 (R)

LAGB (Lap-Band)(n = 37)

44.5 ± 4 12 months: 34.5 ± 20% (n = 28)24 months: 36 ± 23% (n = 24)36 months: 38 ± 27% (n = 15)48 months: 44% (n = 4)

Nehoda et al., 2001 (R)

LSAGB (n = 320) 44.29 12 months: 68%

Belachew et al., 2002 (R)

LAGB (n = 763) 42 (35–65) 6 months: 30%1 year: 40%2 years: 50%4 years: 50–60%

* See appendix for detailed data in Tables E-1, E-3, E-4, E-5, F-2 and F-3.

CR: comparative randomized study; P: prospective non-comparative study; PCC: prospective, controlled, non-randomized comparative study; PNCC: prospective, non-controlled, non-randomized comparative study; R: retrospective non-comparative study; RNCC: retrospective, non-controlled, non-randomized study; n: number of patients.

22

TABLE 5

Outcomes of studies on adjustable gastric banding (AGB) (cont’d)

AUTHORS AND YEAR

(STUDY DESIGN)

TYPE OF PROCEDURE

BMI(kg/m2)

EWL

Dixon and O’Brien, 2002 (R)

LSAGB (n = 50 patients with type 2 diabetes)

48.2 ± 8 1 year: 38 ± 14%

Doherty et al., 2002 (PNCC)

Group 1: Kusmak AGB(n = 40) (March 1992 to May 1995)

Group 2: Lap-BandLAGB (n = 17)AGB (n = 5)(1995 to January 7, 1997)

50

47

Group 1 Group 21 year 44% (n = 40) 27% (n = 19)2 years 47% (n = 40) 28% (n = 18)3 years 33% (n = 31) 25% (n = 18)4 years 40% (n = 24) 17% (n = 17)5 years 30% (n = 20) 21% (n = 15)6 years 32% (n = 18) 15% (n = 13)7 years 33% (n = 15)8 years 32% (n = 13)

Rubenstein, 2002 (R)

LAGB (n = 63) 48.8 ± 8 (36.8–67)

6 months: 27.2 ± 14.2% (n = 62)1 year: 38.3 ± 15.6% (n = 59)2 years: 46.6 ± 19.5% (n = 19)3 years: 53.6 ± 23.8% (n = 13)

Blanco-Engert et al.,2003 (CR)

LAGB (Lap-Band) (n = 30)LAGB (Heliogast) (n = 30)

43.4

41.2

3 months: 6 months: 12 months: (p < 0.0001) (p < 0.0001) (p < 0.0001)12.2 ± 1.3% 26.4 ± 2.88% 41.7 ± 2.71%

9.4 ± 1.39% 17.1 ± 1.65% 28.3 ± 2.40%

Biertho et al.,2003 (RNCC)

LAGB (n = 805) 42.2 ± 4.9(29–64)

6 months: 21.9%12 months: 33.3%18 months: 40.4% (97% of the patients)

Steffen et al., 2003 (P)

LSAGB (n = 824) 42.4 ± 1(31–69)

1 year: 29.5 ± 0.5% (n = 821)2 years: 41.1 ± 0.7% (n = 744)3 years : 48.7 ± 0.9% (n = 593)4 years: 54.5 ± 1.2% (n = 380)5 years: 57.1 ± 1.9% (n = 184)

Angrisani et al., 2004a (R)

LAGB (Lap-Band) (n = 381 out of 573) A: 30–39.9 (n = 166)

B: 40–49.9 (n = 302)C: 50–59.9 (n = 96)D: ≥ 60 (n = 9)

5 years:A: 54.6 ± 32.3% (n = 96)B: 54.1 ± 17.2% (n = 214)C: 51.6 ± 35% (n = 64)D: 59.1 ± 17.1% (n = 7)

Angrisani et al.,2004b (R)

LAGB (Lap-Band) (n = 210 patients with BMIs ≤ 35)

33.9 ± 1.1(25.1–35)

6 months: 28.1 ± 20.7% (n = 210/210)1 year: 52.5 ± 13.2% (n = 182/197)2 years: 61.3 ± 14.7% (n = 119/148)3 years: 64.7 ± 12.2% (n = 75/99) 4 years: 68.8 ± 15.3% (n = 49/73)5 years: 71.9 ± 10.7% (n = 21/29)

23

A multicentre retrospective study by Angrisani et al. [2004a] presented the outcomes obtained for 381 (66.5%) of the 573 subjects studied fi ve years after placement of a Lap-Band adjustable gastric band. Of these patients, 155 were lost to follow-up, 24 had to have the band removed because of complications, 8 had had another type of bariatric surgery, and 5 (0.9%) died from causes unrelated to the procedure. Detailed outcomes by patient group classifi ed by initial BMI (Table 5) show that the EWL exceeded 50% in all the groups. The mortality rate was signifi cantly higher in the group with BMIs from 50 to 59.9 kg/m2: 3.1% vs 0.87% for all the groups combined. Gastric pouch dilatation occurred in 4.1% of the patients, but in 7.2% of those with BMIs from 30 to 39.9 inclusively. Intragastric band migration (erosion) was diagnosed in 2.1% of cases (Table E-4, Appendix E).

Angrisani et al. [2004b] also specifi cally studied 210 patients with BMIs less than or equal to 35 kg/m2. For the study patients overall, the BMI dropped from 28.7 ± 3.8 kg/m2, with an EWL estimated to be 61.3 ± 14.7% at two years (for more than half of the surgical patients). These outcomes seemed stable at fi ve years (BMI = 28.2 ± 0.09 kg/m2 and EWL = 71.9 ± 10.7% in 21 of the 29 patients who were followed up) (Table 5). A single death was reported at 20 months; it was due to sepsis caused by perforation of the dilated gastric pouch (Table E-4, Appendix E).

The other LAGB studies involved patients with mean BMIs varying between 41 and 48.8 kg/m2, but their post-operative follow-up periods were very heterogeneous, from 12 to 96 months. Outcomes also varied widely in terms of clinical indicators such as mean operating time (35–193 minutes) and post-operative hospital stay (1–7 days). These variations can largely be explained by the surgical team’s learning curve: as patient numbers increase, operating times decrease [Rubenstein, 2002] and fewer complications arise (most often band-related: slippage, erosion, leakage, etc.). The effi cacy of LAGB expressed as post-operative EWL (actual

value or percent decrease) varied with the length of the follow-up period. At one year, the EWL was between 30% and 68%, and longer-term (fi ve-year) values were generally between 50% and 60% (Table 5 and Tables E-1, E-3, E-4 and E-5, Appendix E). Post-operative outcomes after LAGB procedures were similar to those obtained after open procedures, and they had a positive impact on patients’ quality of life [Hell et al., 2000].

Two randomized comparative studies of different methods of implanting adjustable gastric bands (conventional or retrogastric vs esophagogastric) arrive at different conclusions [Weiss et al., 2002; Weiner et al., 2001]. Even if the outcomes are similar from the standpoint of effi cacy (weight loss), the practitioners have diverging opinions on esophagogastric placement (Tables 5 and E-2, Appendix E). According to Weiner et al. [2001], this method is easier to perform and safer, and the complication rate is lower than with retrogastric placement (signifi cant difference). The study by Weiss et al. [2002], for its part, reports higher complication and re-operation rates with esophagogastric placement. The limited number of subjects (101 for Weiner and 54 for Weiss) and the relatively short follow-up (18 and 24 months) do not permit defi nitive conclusions.

In a randomized study, Blanco-Engert et al. [2003] compared the outcomes achieved after having implanted two types of adjustable bands (Lap-Band® and Heliogast®)7 in two groups of 30 patients (Table 5). At 12 months, they found that the Heliogast patients had much lower EWLs (28.3 ± 2.40 vs 41.7 ± 2.71%; p < 0.0001) and a higher number of complications than the Lap-Band patients (signifi cant difference). According to the authors, the Heliogast should no longer be used or should at least be reserved to specifi c patients such as those over the age of 60 (Table E-3, Appendix E).

The randomized comparative study by de Wit et al. [1999] involved 50 patients divided

7. The Lap-Band is manufactured by the U.S. fi rm Inamed, and the Heliogast, by the French fi rm Hélioscopie.

24

equally into two groups (open AGB vs LAGB) with no signifi cant differences as to their characteristics (male-female ratio, weight, BMI and co-morbidities). (This study does not appear in Table 5 because the outcomes are not expressed as EWL: see Table E-5 in Appendix E.) At one year, there was no signifi cant difference in the number of post-operative or early complications, while weight loss was similar in the two groups. However, laparoscopy was associated with a shorter hospital stay and a lower number of re-admissions than with the open procedure (signifi cant differences).

The outcomes of a retrospective, comparative study by Fried [2000] (presented only in Table E-5 in Appendix E) show a signifi cant difference in post-operative length of stay in favour of patients who underwent laparoscopic procedures (2.8 days vs 10.5 days for the open procedure) and a substantial decrease in the number of early complications related to open surgery (1%), with appreciably equivalent effi cacy (mean weight loss of 37.6 kg in the laparoscopic group vs 38.4 kg in the open-surgery group).

The non-randomized comparative study by Doherty et al. [2002] was carried out with two groups of patients who underwent adjustable gastric banding (the Kusmak type of SAGB for the open procedure, and the Lap-Band for laparoscopic placement [17 cases] and for open placement [5 cases]). The outcomes indicate a large number of re-operations and band removals caused by the onset of complications or band intolerance. These outcomes seem exceptional because, according to a review article, most of the recent studies report conversion rates of less than 5% and a much smaller number of complications [Fried et al., 2002] (Table E-5, Appendix E). With respect to long-term effi cacy, in the study by Doherty et al. [2002], excess weight loss rose to 47% at two years but gradually dropped to 32% at six years of follow-up. Excess weight loss was even lower in the Lap-Band group (28% at two years and 15% at six years) (Table 5). These outcomes do not agree with those of the other studies under

review, and their validity is weakened by the small sample size.

4.2.2 Comparison of the techniques

4.2.2.1 BILIOPANCREATIC DIVERSION VS OTHER TYPES OF BARIATRIC-SURGERY PROCEDURES

Only two retrospective studies have compared biliopancreatic diversion with other surgical techniques [Bajardi et al., 2000; Rabkin, 1998] (Table 6).

4.2.2.1.1 Biliopancreatic diversion (BPD ) and biliopancreatic diversion with duodenal switch (BPD-DS ) vs Roux-en-Y gastric bypass (RYGB)

When Rabkin [1998] retrospectively compared three bariatric-surgery techniques (RYGB, Scopinaro’s BPD and BPD-DS), he noted that the medium-term effi cacy of BPD-DS (at two and four years of follow-up) was similar to that of the other two techniques. However, in the fi rst 37 patients in the group of 105 subjects who underwent BPD-DS, four cases of severe operative complications occurred (two cases of peritonitis, one pancreatitis, and one thrombophlebitis associated with pulmonary embolism). Given that the results on the complications and the mortality rates are neither complete nor available for the two other surgical techniques, it is diffi cult to pass judgment on the overall superiority of any one of them (Table F-1, Appendix F).

4.2.2.1.2 Biliopancreatic diversion (BPD) vs vertical banded gastroplasty (VBG)

A comparative study of two groups of obese adult patients treated with VBG (n = 93) and with BPD (n = 142) indicates that, after two years of post-operative follow-up, the mean percentage of EWL was higher in the BPD group: 60% vs 48% in the VBG group. It is not indicated, however, if this difference is statistically signifi cant. Moreover, the operating time, the mean hospital stay and the mortality rate were higher in the BPD group. Virtually

25

all the early complications occurred among the BPD patients (7.3%), which could explain the longer operating time for this procedure. The incidence of late complications was the same in both groups, but there was a greater prevalence of malnutrition syndromes in the BPD group and of gastric stenoses in the VBG group. In addition to its weight-reduction effi cacy, the authors emphasize that it reduced and even resolved some of the co-morbidities present before the procedure. All the patients reported improvements in their physical activity and the resolution of sleep apnea [Bajardi et al., 2000].

The authors conclude that the choice of either technique depends on the patient’s clinical and psychological characteristics. They are of the opinion that BPD should be reserved to super-obese patients (BMI > 50 kg/m2) who present with severe dyslipidemia and agree to long-term follow-up. However, the weakness of their study design (retrospective) limits the validity and scope of their study outcomes (Table F-1 Appendix F).

4.2.2.2 VERTICAL BANDED GASTROPLASTY (VBG) VS VERTICAL BANDED GASTROPLASTY COMBINED WITH ROUX-EN-Y GASTRIC BYPASS (VBG-RYGB)

In their retrospective study, Capella and Capella [1996] compared vertical banded gastroplasty combined with Roux-en-Y gastric bypass (VBG-RYGB) with VBG alone. The VBG-

RYGB procedure is analogous to the basic gastric-bypass procedure performed at the Royal Victoria Hospital, McGill University Health Centre (MUHC). This retrospective study analyzed 888 surgically treated obese subjects (328 with VBG and 560 with VBG-RYGB, all by the same surgeon) followed up from 30 to 66 months. There was no signifi cant difference between the two groups in terms of age, male-female ratio, initial BMI and relative number of super-obese patients.

The outcomes show a signifi cantly higher EWL rate in those who underwent VBG-RYGB (62 ± 17% at fi ve years’ mean follow-up) compared with those in the VBG group (47 ± 23%) (Table 7). While the early complication rates were 0.3% and 1% in the VBG and VBG-RYGB groups respectively, late complications rose to 9% and 12% respectively. The authors point out that, among the fi rst 272 people who underwent VBG-RYGB, the late-complication rate was 22% but dropped to 1% in the following 351 patients. In most cases, these complications were due to staple-line disruption (Table F-2, Appendix F). In a more recent study of a series of 652 consecutive patients, of whom 72 were followed up for fi ve years, the same authors confi rm the effi cacy of VBG-RYGB for super-obese patients (mean EWL of 77% at fi ve years) and recommend it without reservations [Capella and Capella, 2002] (Table C-1, Appendix C).

TABLE 6

Studies comparing biliopancreatic diversion with other open-surgery techniques*

AUTHORS AND YEAR

(STUDY DESIGN)

TYPE OF PROCEDURE

BMI(kg/m2)

EWL

Rabkin, 1998 (RNCC) BPD (n = 32)

RYGB (n = 138)BPD-DS (n = 105)

454949

24 months 48 months 69% 73% 74% 63% 78% 73%


VBG (n = 93) (1990–1995)BPD (n = 142) (1993–1998)

48.7 (37–65.6)50 (35–81)

48% after 2 years60% after 2 years

* See detailed data in Table F-1, Appendix F.

RNCC: retrospective, non-controlled, non-randomized comparative study; n: number of patients.

26

4.2.2.3 VERTICAL BANDED GASTROPLASTY (VBG) VS ROUX-EN-Y GASTRIC BYPASS (RYGB) VS LAPAROSCOPIC SWEDISH ADJUSTABLE GASTRIC BANDING (LSAGB)

In a prospective study, Hell et al. [2000] compared VBG, RYGB and LSAGB in terms of effi cacy and quality of life. Each of the three groups included 30 patients matched by sex, BMI and age. While excess weight loss (EWL) was similar in the VBG and LSAGB groups (17 and 16 patients respectively had lost more than 50% of their initial excess weight), this fi gure rose to 28 patients in the RYGB group, in which 22 patients had lost excess weight greater than or equal to 75% (compared with two patients in the VBG group and one in the LSAGB group) (Table 8). However, unlike the weight-loss outcomes, the BAROS scores did not indicate such great superiority in terms of improved quality of life (QoL) for the patients in the RYGB group (BAROS score: 7.15 for RYGB, 6.13 for VBG and 5.99 for LSAGB). The outcomes obtained by Hell and Miller [2000] with a larger group of patients (101 for VBG and 99 for LSAGB) showed similar performances in terms of EWL, both at two years and at fi ve years. This study had also stratifi ed patients by age, sex and initial BMI (Table 8).

4.2.2.4 LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGB) VS LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING (LAGB)

The most recent comparative study presents the outcomes obtained for more than 1200 patients treated with LRYGB at the Mount Sinai Medical Center in New York (n = 406) or with LAGB at the Obex Institute in Switzerland (n = 805). For patients with BMIs > 50 kg/m2, the length of the Roux-en-Y limb was 150 cm [Biertho et al., 2003]. Data were collected retrospectively for the LRYGB group and prospectively for the

LAGB group. At the time of inception, the two comparison groups had signifi cantly different weights and BMIs (p = 0.0001), which were greater in the patients treated with LRYGB in New York, as shown in Table 9.

Eighteen months after the procedure, the LRYGB patients had lost a signifi cantly higher percentage of excess weight than the LAGB patients (74.6% vs 40.4%; p < 0.0001). However, LRYGB led to more complications than LAGB, especially major early complications (4.2% vs 1.7%; p = 0.02), intra-operative complications (2% vs 1.3%) and deaths (0.44% vs 0%): in the last two cases, the difference was not signifi cant (Table F-3, Appendix F.) According to the authors, it is not yet possible to pass judgment on the best indication for each technique, but it probably depends on a certain number of factors such as initial BMI, dietary patterns and co-morbidities. Nevertheless, LAGB could be indicated for patients with BMIs between 30 and 40 kg/m2, while LRYGB would be better suited to more obese patients (40–50 kg/m2). The authors add that, for subjects with BMIs greater than 50 kg/m2, another type of procedure—such as biliopancreatic diversion—would be preferable.

Despite its large size, this comparative study suffers from some major methodological biases. First of all, the groups were heterogeneous, given that the weight of the patients in the LRYGB group was greater than that of the patients in the LAGB group, and the percentages of patients followed up at 18 months differed (37% vs 97%). In addition, the study compared surgeons practising in very different settings (Switzerland and the United States), even though several authors have emphasized the relationship between bariatric-surgery outcomes and the surgical learning curve [DeMaria, 2003; Gagner and Rogula, 2003].

27

TABLE 7

Comparative study of open vertical banded gastroplasty*

AUTHORS AND YEAR

(STUDY DESIGN)

TYPE OF PROCEDURE

BMI(kg/m2)

OUTCOMES

Capella and Capella,1996(RNCC)

VBG (329 operations on 328 patients)

VBG-RYGB (623 operations on 560 patients: in 351 cases, gastric segments were completely separated)

52 ± 9

52 ± 9

30 to 42 months 54 to 66 monthsEWL (%) 48 ± 23 47 ± 23BMI (kg/m2) 39 ± 9 40 ± 9

EWL (%) 70 ± 19 62 ± 17BMI (kg/m2) 32 ± 6 34 ± 6


RNCC: retrospective, non-controlled, non-randomized comparative study.

TABLE 8

Outcomes of studies comparing VBG with other bariatric-surgery techniques*

AUTHORSAND YEAR

(STUDY DESIGN)

TYPE OF PROCEDURE

BMI OR INITIAL

WEIGHTEWL

Hell et al., 2000 (PCC) VBG (n = 30)

LSAGB (n = 30)RYGB (n = 30)

46.9 ± 9.9 kg/m2

46.9 ± 7.8 kg/m2

45.2 ± 8.2 kg/m2

0–24% 25–49% 50–74% 75–100% Follow-up (mos)n = 1 12 15 2 40.1 ± 8.3 n = 1 13 15 1 39.7 ± 7.6 n = 0 2 6 22 60.0 ± 8.2

Hell and Miller, 2000 (PNCC) VBG (n = 101)

46.9 ± 9.0 kg/m2

133.7 ± 33.3 kg2 years: 61% (40 kg) (n = 98)5 years: 69% (48 kg) (n = 15)

LSAGB (n = 99)46.9 ± 7.8 kg/m2

133 ± 22.7 kg2 years: 59% (46 kg) (n = 97)5 years: 71% (56 kg) (n = 16)


PCC: prospective, controlled, non-randomized comparative study; PNCC: prospective, non-controlled, non-randomized comparative study; n: number of patients.

28

TABLE 9

Outcomes of the study (RNCC) by Biertho et al. [2003]*

NUMBER OF

PATIENTS

INITIAL WEIGHT AND BMI

HOSPITAL STAY (MEDIAN

IN DAYS)

FOLLOW-UP† EWL (%) IN RELATION TO PRE-OPERATIVE BMI

Patients (%) Length 30–40 40–50 50–60 All‡

456

(LRYGB)

Weight (kg): 135.4 ± 26.3 (76–221)

BMI (kg/m2): 49.4 ± 8.3 (27–77)

3 ± 0.3(2–94)

88 6 months57 12 months37† 18 months

55 56 47 51.6 75 72 57 67.0 – 81 69 74.6

805

(LAGB)

Weight (kg):117 ± 17.1(75–224)

BMI (kg/m2):42.2 ± 4.9(29–64)

5 ± 2.4(2–22)

97 6 months97 12 months97† 18 months

24 21 18 21.9 37 32 26 33.3 41 40 33 40.4

* Detailed outcomes for this study can be found in Table F-3, Appendix F.† The authors attribute the difference in survival rates at 18 months (37% and 97%) to the gastric-bypass procedure itself (which requires more assessments, whereas the patients come from diverse regions that are sometimes quite far), making long-term follow-up diffi cult.‡ All the differences between the two groups, regardless of the length of follow-up, are signifi cant: p < 0.0001.

RNCC: retrospective, non-controlled, non-randomized comparative study.

4.2.2.5 ADJUSTABLE GASTRIC BANDING (AGB) VS NON-ADJUSTABLE GASTRIC BANDING (NAGB)

After reviewing studies published between September 2000 and September 2001, Fried et al. [2002] compared the effi cacy of adjustable gastric banding (AGB) with that of non-adjustable gastric banding (NAGB). The effi cacy outcome measures selected for this comparison were early and late complications, number of re-operations and weight loss after a minimum post-operative follow-up of three years.

Four centres performing NAGB procedures were chosen (Spain, Israel, Czech Republic and United States). The technique and materials used during the four study years were considered to be similar. In total, 1812 patients treated with NAGB were compared with 1968 patients treated with AGB (Table 10). The outcomes of this study show that at 48 months, the percentages of EWL and the early complication rates were virtually the same in both groups. However, the authors found signifi cant

differences in the rates of late complications (6.7% vs 1.9%) and re-operations (7.2% vs 3.4%) in favour of NAGB. They add that the materials used in NAGB offer greater fl exibility and are better adapted to gastric peristalsis, which could lessen irritation and give the band a greater physiological effect.

4.2.2.6 COMPARISON OF THE FOUR MAIN TYPES OF BARIATRIC SURGERY: TWO META-ANALYSES

In a meta-analysis of 136 studies, Buchwald et al. [2004] evaluated the effi cacy of different types of bariatric surgery (gastroplasty, gastric bypass, adjustable and non-adjustable gastric banding, and biliopancreatic diversion) in relation to weight outcome measures (absolute weight loss in kilograms, decrease in BMI, percentage of initial weight loss or percentage of excess weight loss). They also examined the impact of these procedures on the progression of obesity co-morbidities (mainly type 2 diabetes, hypertension, hyperlipidemia and sleep apnea).

29

TABLE 10

Outcomes of the comparative review of AGB and NAGB*

AUTHORS OF PRIMARY

STUDIES

AGB1968 PATIENTS

MEAN BMI: 44.0 kg/m2

NAGB1812 PATIENTS

MEAN BMI: 42.4 kg/m2

Forsell(2000)

Hell and Miller, (2000)

Belva et al.

(2001)

Favretti et al.

(2001)

Mean values†

Ballesta et al.

(1998)

Dudai(1999)

Friedet al.(1999 and

2000)

Molina(2000 and

2001)

Mean values†

Number of patients 376 99 + 69 763 830 306 (336)

1919(931)487

(6906)512

EWL (%)at 48 months 68 65 – 55 53 68 70 54 – 54.2

Early complications (%)

2.1 2.0 0.8 0.2 1.6 2.5 1.5 1.1 0.6 1.4

Late complications (%)

4.0 2.2 9.0 3.3 6.7 1.8 1.8 2.2 1.7 1.9

Re-operations (%) 7.0 9.0 11.1 3.9 7.2 1.95 1.78 6.3 3.1 3.4

Source: Fried et al., 2002.

* The results are presented here as they appear in the article. For further details on the case series studied, please consult the references cited by Fried et al. † The values in bold are the variables in which a signifi cant difference is observed between the two groups.

This meta-analysis involved a total of 22,094 patients identifi ed in studies published until July 2003: 5 controlled randomized trials, 28 non-randomized controled studies, 101 case series and 2 health-care economic studies. Of these studies, 58 were conducted in Europe, 56 in North America and the remainder in various countries around the world (Australia, New Zealand, South America, etc.). Some of the studies included in this meta-analysis will be evaluated separately in this report.

The outcomes confi rm the general effi cacy of bariatric surgery, with EWL rates on the order of 61.23% (95% CI: 64.40–58.06) for all the study patients combined (10,172), although this rate varies by type of procedure: 47.45% EWL for gastric banding, 61.56% for gastric bypass, 68.17% for gastroplasty and 70.12%

for biliopancreatic diversion (Table 11). Note, however, that each treatment group included several variants and that the number of treated patients differed (e.g., 4204 patients underwent gastric bypass and 506, gastroplasty). In addition, the outcomes are not presented according to the number of months or years of follow-up, except it is mentioned that weight-loss outcomes did not differ signifi cantly at assessments at two years or less compared with those at more than two years. The post-operative mortality rate (within 30 days of the procedure) was 0.1% for restrictive procedures (gastroplasty and gastric banding), 0.5% for gastric bypass, and 1.1% for biliopancreatic diversion. Outcomes related to a reduction in the signs and symptoms of the main co-morbidities will be dealt with in section 4.4.

30

TABLE 11

Outcomes of the meta-analysis by Buchwald et al. [2004] comparing the main types of bariatric surgery*

GASTROPLASTY(MAINLY VBG)

RYGB(INCLUDING VARIANTS)

GASTRIC BANDING (ADJUSTABLE AND NON-ADJUSTABLE)

BPD(INCLUDING VARIANTS)

ALL PROCEDURES COMBINED†

Weight loss† (kg)

936 patients(28 groups)

–39.82(–44.74 to –34.90)‡


–43.48(–48.14 to

–38.82)


–28.64(–32.77 to

–4.51)


–46.39(–51.58 to

–41.20)


- 39.71(- 42.23 to

- 37.19)

Decrease in BMI†

(kg/m2)


–14.20(–16.14 to

–12.27)


–16.70(–18.43 to

–14.98)


–10.43(–11.52 to

–9.33)


–17.99(–19.40 to

–16.59)


–14.20(–15.13 to

–13.27)

EWL(%)


–68.17(–74.81 to

–61.53)


–61.56(–66.45 to

–56.68)


–47.45(–54.23 to

–40.68)


–70.12(–73.91 to

–66.34)

10,172 patients(67 groups)

–61.23(–64.40 to

–58.06)

NB.: Unlike in the other tables, negative results are included to respect the author’s presentation, especially for the confi dence intervals.

* Includes Roux-en-Y gastric bypass, gastric banding, gastroplasty, biliopancreatic diversion and mixed techniques, along with other less common procedures (biliary-intestinal bypass, ileogastrostomy, jejuno-ileal bypass, and unspecifi ed bariatric surgery.† Whenever possible, outcome time points representing at least 50% of the patient population undergoing surgery were used.‡ 95% confi dence interval. The p-value is signifi cant for heterogeneity (cross-study variation), except for the initial weight loss induced by gastric bypass or by biliopancreatic diversion with or without duodenal switch.

Another very recent meta-analysis (April 2005) also compares the same four techniques in terms of weight loss at 12 months and at 36 months or more, mortality and complications [Maggard et al., 2005]. Of the 167 studies identifi ed, 89 were eligible to be selected for weight-loss analysis. The outcomes (Table 12) generally tally with those of the meta-analysis by Buchwald et al., except for VBG, which achieved lower outcomes. Overall, the outcomes at 36 months differ little from those at 12 months, despite slight downward trends for RYGB and upward trends for AGB and BPD. It can also be seen that the surgical approach (laparoscopy or open surgery) has little impact on the outcomes achieved with RYGB, although a single study presents three-year outcomes for the laparoscopic procedure. Finally, overall mortality remains less than 1%, whether the deaths occur 30 or fewer days post-operatively.

4.3 COMPLICATIONS

Examining surgical complications is a diffi cult task. In the selected studies, the incidence and nature of the complications vary by type of procedure and surgical approach; early and late complications are not systematically differentiated; and the studies generally use different analytical frameworks.

There are different types of bariatric-surgery complications: they are mainly infectious, lesional (wound dehiscence, hernias, etc.) and metabolic (anemia, hypocalcemia, etc.). Other complications are linked directly to the gastric band. Gallstone formation, not a rare event, is attributable to excessively radical weight loss, and may occur with non-surgical approaches. The pathogenesis has not yet been clarifi ed [Stocker, 2003].

31

TABLE 12

Outcomes of the meta-analysis by Maggard et al. [2005] comparing the main types of bariatric surgery*

PROCEDURE

FOLLOW-UP AT 12 MONTHS FOLLOW-UP AT 36 MONTHS AND MORE

WEIGHT LOSSIN KG

(95% CI)

STUDIES (PATIENTS)

WEIGHT LOSSIN KG

(95% CI)

STUDIES (PATIENTS)

RYGB (all) 43.46 (41.24–43.46) 32 (n = 2937) 41.46 (37.36–45.56) 21 (n = 1281)

RYGB (open) 43.89 (41.09–46.69) 25 (n = 2074) 41.58 (37.38–45.78) 20 (n = 1266)

LRYGB 42.17 (38.95–45.38) 10 (n = 863) 38.32 (28.04–48.60) 1 (n = 15)

VBG (all) 32.16 (29.92–34.41) 21 (n = 2080) 32.03 (27.67–36.38) 18 (n = 1877)

AGB (all) 30.19 (27.95–32.42) 27 (n = 5562) 34.77 (29.47–40.07) 17 (n = 3076)

BPD (all) 51.93 (45.10–58.75) 3 (n = 735) 53.10 (47.36–58.84) 1 (n = 50)

CI: confi dence interval; n: number of patients.

(Tables B-1, B-2, F-1 and F-2, Appendices B and F).

4.3.3 Complications from biliopancreatic diversion

According to the limited data available, complication rates from biliopancreatic diversion vary and may reach 24% for incisional hernias; the mortality rate is between 1% and 4%. It should be mentioned that these outcomes were obtained in patients with particular characteristics (high BMIs or co-morbidities). In addition to common bariatric-surgery complications (hernias, infections, pulmonary embolisms), studies indicate a high percentage of malnutrition syndromes for specifi c nutrients (vitamins, iron, and hyperproteinemia) (19% in the study by Bajardi et al. [2000]) (Tables D-1, D-2, D-3 and F-1, Appendices D and F).

4.3.4 Complications from laparoscopic procedures

With respect to complications from laparoscopic procedures, adjustable gastric banding achieves the best results. Complication rates vary by time of onset (early or late), type (hernias, erosion, infections, pouch dilatation) and degree of severity (from simple gastro-esophageal refl ux

4.3.1 Complications from gastric bypass

The rates of early and late gastric-bypass complications, especially from Roux-en-Y, vary between 0.3% and 2.7% and between 2.2% and 13% respectively. These relatively low values refl ect improvements in the performance of this procedure, given that a study published in 1995 reported early complication rates that were 10 times higher (25.5%) [Pories et al., 1995]. Late complications are most often due to staple-line disruption or hernia development. The risk of pulmonary embolism is nevertheless lower with gastric bypass. The systematic administration of nutritional supplements (iron, vitamin B12, folic acid and calcium) after these operations contributes to the absence of metabolic complications. The mortality rate is less than or equal to 1% (Tables C-1, C-2, C-3, F-1 and F-3, Appendices C et F).

4.3.2 Complications from gastroplasty

In their comparative study, Capella and Capella [1996] documented a 9% complication rate in 328 patients treated with VBG. Complications were most often related to leakage caused by band migration or staple-line disruption. In the other studies, these rates varied between 3% and 21%. The mortality rate remained less than 0.5%

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to complications that are severe, and even fatal, or that require re-operation). In most cases, complications are minor and re-operations are required to remove, replace or adjust the gastric band. The decline in complication rates is mainly due to the surgical learning curve and to enhanced gastric bands [Steffen et al., 2003; Doherty et al., 2002; Fried et al., 2002] (Tables E-1 to E-5, Appendix E).

In a review of 3464 cases identifi ed in 10 different studies (published between January 1, 1994, and December 31, 2002), Podnos et al. [2003] evaluated the number and type of complications resulting from laparoscopic RYGB. These data were compared with 2771 cases of conventional RYGB (open procedure) from 8 studies published over the same period. According to 9 of the 10 studies, the conversion rate from laparoscopic to open surgery is estimated to be 2.2%, the main reason being hepatomegaly (48.7% of cases). The laparoscopic approach leads to decreased wound-related complications (infections and hernias), iatrogenic splenectomies and mortality. In return, it is associated with an increase in complications that rarely occur with open surgery, including early or late intestinal obstruction, gastro-intestinal tract bleeding, and stomal stenosis. The authors attribute part of this increase to the learning curve for this new technique. As a result, they recommend that professional associations provide better training for surgeons interested in performing this type of procedure. These conclusions confi rm the outcomes previously reported by Luján et al. [2004] and those by Westling et al. [2002] (Table C-3, Appendix C), who also support stricter patient selection as a means of reducing the number of conversions.

4.4 IMPACT OF BARIATRIC SURGERY ON OBESITY CO-MORBIDITIES

Besides the weight-reduction effi cacy of bariatric surgery, several authors affi rm that it

reduces and even resolves some pre-operative co-morbidities. Essentially on the strength of the SOS study, the Blue Cross and Blue Shield Association published a report on the impact that post-operative weight loss could have on the progression of diseases associated with morbid obesity [BCBS, 2003a]. According to the outcomes achieved by Sjöström et al. [1999], the incidence of diabetes, two years after surgery, was 30 times lower among the 767 surgical patients than it was among the 712 non-surgical patients (two-year incidence: 0.2% vs 6.3%; p < 0.001). This reduction was on the order of 10 for hypertriglyceridemia (0.8 vs 7.7%; p < 0.001) and 2.5 for hypertension (5.4 vs 13.6%; p < 0.001). In the fi rst two groups of patients (517 surgical and 539 non-surgical patients) followed up for 10 years, the difference was maintained for diabetes, the incidence of which was four times lower in the surgically treated group (odds ratio [OR] = 0.25; 95% confi dence interval [CI]: 0.17–0.38; p < 0.001). However, if only the fi rst groups of patients are analyzed, the difference decreases for hypertriglyceridemia (OR = 0.61; CI: 0.39–0.95; p < 0.03) and is no longer signifi cant for hypertension (OR = 0.75; CI: 0.52–1.08; p < 0.06) [Sjöström et al., 2004]. All these outcomes were associated with decreased body mass in the obese patients.

The Swedish study also shows reductions of 56% and 48% in the number of patients meeting the diagnostic criteria for depression or anxiety after the surgical procedure [Karlsson et al., 1998]. The authors of the Blue Cross and Blue Shield Association report also analyzed the outcomes of 11 additional studies, including one randomized trial. Their data confi rm the results of the Swedish study [BCBS, 2003a].

Although some authors have tried to establish the precise relationship between the amount of weight loss and the improvement in some outcome measures (diabetes, arthritis, glycemia, glycosylated hemoglobin, SF-36, etc.) and to derive clinical signifi cance from it, the Blue Cross and Blue Shield Association [2003a] concludes that it is not possible to generalize

33

from the conclusions they reached. According to them, neither is it possible to set an objective weight-loss cut-off point to determine the success of a surgical procedure.

According to the results of other studies and depending on the surgical technique (VBG, RYGB, GB, LAGB), the quality of life enjoyed by 90% to 98% of the patients improved, and co-morbidity symptoms were reduced in 50% to 80% of cases [Schauer et al., 2003a; Stocker, 2003; DeMaria et al., 2002b; Frezza et al., 2002]. However, most of the studies do not examine the progression of health problems associated with obesity. A few rare studies, such as those by Bajardi et al. [2000] and by Kim et al. [2003], indicate the effects of bariatric surgery on co-morbidities. After having studied its impact on 142 BPD-DS patients and 93 VBG patients, Bajardi et al. recorded a reduction in the clinical symptoms associated with lower-limb chronic venous insuffi ciency in 95% of the cases, discontinuation of anti-hypertensive treatment in 90% of the cases, and a return to normal blood lipid levels (cholesterol and triglycerides) in 100% of the cases. All the diabetic patients required to take insulin stopped all injections after one year, and only 21% of diabetics continued taking oral hypoglycemic medications. Finally, most of the patients reported increased physical activity because weight loss reduced their osteoarthropathy or improved their cardiopulmonary performance [Bajardi et al., 2000].

The outcomes of the study by Kim et al. [2003], who compared open BPD-DS (28 patients) and laparoscopic BPD-DS (26 patients), show improvement in some of the patients’ clinical conditions with respect to co-morbidities, mainly diabetes, sleep apnea, hypertension, asthma, and arthritis. These improvements translated into lower doses of medication and were signifi cantly greater in the group that had undergone laparoscopic BPD-DS (eight patients in the laparoscopy group and two in the open-surgery group). Hypertension and asthma were reduced by 20% in the laparoscopy group, while in the open-surgery group, hypertension was

reduced by 8.3% and asthma by 17%. As for the other co-morbidities, only the data from the LBPD group were published. Similar outcomes were achieved in 51 obese patients with type 2 diabetes who had undergone LAGB: remission of diabetes occurred in 32 of these patients [Dixon and O’Brien, 2002].

These outcomes are confi rmed by four studies published in 2004 (three in the United State and one in Québec), which analyzed the effects of bariatric surgery on the progression of co-morbidities. In the U.S. studies, the assessments included estimated cost savings derived from bariatric surgery as a result of a reduction in the signs and symptoms, or resolution, of co-morbidities associated with clinical obesity.

Potteiger et al. [2004] retrospectively reviewed the use of hypertension and diabetes medications pre-operatively and at 9 months post-operatively in 51 consecutive patients with morbid obesity (BMIs greater than 40 kg/m2 with an associated co-morbidity, or BMIs greater than 45 alone) who underwent RYGB (30 with the open approach and 21 laparoscopically). Total control or a favourable progression of the disease was achieved by 92% (n = 47) of the patients with diabetes, and by 78% (n = 40) of the patients with hypertension. This progression was associated with a signifi cant decrease in medication usage. It fell from 1.12 ± 1.15 to 0.12 ± 0.48 (p < 0.001) for diabetes medications, and from 1.32 ± 1.25 to 0.44 ± 0.64 for anti-hypertensive agents (p < 0.001) (Appendix H).

In their retrospective study, Monk et al. [2004] focused on the progression of the fi ve major obesity co-morbidities (type 2 diabetes, hypertension, sleep apnea, gastro-esophageal refl ux disease, and asthma). Of the 100 patients selected, 87 were taking medications to treat these problems before surgery (RYGB); this number was reduced to 64 patients, owing to relocation or to incomplete pharmacology records; fi nally, follow-up varied from 6 to 60 months (mean of 16 months). The authors acknowledge that the number of patients lost to follow-up and the inadequate follow-up

34

period weaken the validity of their study. The mean BMI of the 64 patients was 57 kg/m2 (range, 36.6–85.4). The outcomes show that 21 of the 23 diabetic patients had discontinued all their medications and that the remaining 2 had reduced their therapeutic doses; the same was true for the hypertensive patients (11 discontinued treatment and the remaining 15 reduced their doses). Patients suffering from sleep apnea (treated with continuous positive-airway pressure), gastro-esophageal refl ux disease and asthma had similar outcomes (Appendix H).

Snow et al. [2004] reported similar results for 78 patients with morbid obesity (BMIs from 36 to 70 kg/m2) who underwent LRYGB between March 2001 and March 2003 (78 patients were followed for one year, and 26 for two years) (Appendix H). In this retrospective study, the authors selected from a database of 1060 patients all those over the age of 54 who had been followed for a minimum of six months: 82 cases were extracted, but 4 were excluded (three deaths before 180 days and one lost to follow-up). Pre-operatively, 324 prescriptions were recorded for 70 patients, and one year later, the number of prescriptions had dropped to 112 for 53 patients. All co-morbidities decreased: hypertension or hypertension with cardiovascular disease, type 2 diabetes, pulmonary insuffi ciency, osteoarthritis, anxiety or depression, hyperlipidemia, gastro-esophageal refl ux disease, and urinary incontinence.

The outcomes of the retrospective comparative study conducted in Québec by Christou et al. [2004] also show improvements in the surgical patients’ health status, chiefl y with respect to cardiovascular disease (4.7% vs 26.7% for non-surgical patients: relative risk [RR] = 0.18), cancer (2.0% vs 8.5%: RR = 0.24), infectious diseases (8.7% vs 37.3%: RR = 0.23), endocrine disorders (9.5% vs 27.3%: RR = 0.35) and psychiatric or mental disorders (4.4% vs 8.2%: RR = 0.61). All these reductions in relative risk are signifi cant (p < 0.001). In return, the rates

of digestive problems were higher in the group of surgical patients (36.4% vs 24.7%: RR = 1.48; p < 0.01). Finally, the mortality rate for the surgical patients was roughly 10 times lower than that for the non-surgical patients (0.68% vs 6.17%, RR = 0.11; 95% CI: 0.04–0.27).

The meta-analysis by Buchwald et al. [2004], cited earlier in section 4.2.2.6 dealing with the weight-reduction effi cacy of bariatric surgery, also shows several positive effects on obesity co-morbidities (Appendix G). According to the data on 63 treatment groups (1846 patients), diabetes was completely resolved in 1417 patients (76.8%; 95% CI: 70.7–82.9%). In 30 other treatment groups (485 patients), it was resolved or improved in 414 patients (86.0%; 95% CI: 78.4–93.7%). The most effective techniques were gastric bypass and gastroplasty. Hyperlipidemia improved in 846 of 1019 patients in 23 treatment groups (79.3%; 95% CI: 68.2–90.5%). Hypertriglyceridemia decreased in 912 of 983 patients in 11 treatment groups (82.4%; 95% CI: 71.1–93.7%). Finally, hypercholesterolemia also improved in 1777 of 2051 patients in 14 treatment groups (71.3%; 95% CI: 55.5–87%). For these three hyperlipidemia outcome measures, the best results were documented with gastric-bypass procedures and biliopancreatic diversions.

Hypertension was controlled in 61.7% of the 4806 patients in 67 treatment groups (95% CI: 55.6–67.8%). In 43 other groups totalling 2141 patients, these problems were resolved or improved in 78.5% of the subjects (95% CI: 70.8–86.1%). Gastric bypass and gastroplasty were more effective in that regard. Lastly, sleep apnea was resolved in 85.7% of the 1195 patients in 38 studies (95% CI: 79.2–92.2%). According to the results of 24 other studies combining 726 patients, sleep apnea was resolved or improved in 83.6% of the patients (95% CI: 71.8–95.4%). It is diffi cult to determine which surgical technique is the most effective, given that effi cacy varies according to the outcome of interest.

35

5 ECONOMIC OUTCOMES

Although these studies were not randomized, they established a comparison between subjects eligible for surgery and willing to undergo it, and subjects matched by sex and 18 variables related to morbidity and mortality. The study by Sjöström et al. [1995], for its part, is more of a modelling exercise than a rigorous analysis. Below are the main fi ndings drawn from analysis of these studies.

A single study attempts to estimate the cost-utility ratio, which proves favourable to the surgical approach: it would result in savings from US$3,928 to US$4,004 per QALY (quality-adjusted life year)8 [van Gemert et al., 1999]. However, this study conducted in the Netherlands is not based on a true comparison between surgical and medical options because it uses a cost-of-illness approach to provide an economic counterpart for comparison. Furthermore, it includes only 21 patients who underwent vertical banded gastroplasty and who were followed for two years. The weight reduction, estimated to be 38.6%, was associated with a gain of 12 QALYs in a lifetime scenario. Productivity gains were estimated in part from the data provided by the subjects.

Several studies have compared resource-utilization outcomes and their associated costs, and have generally demonstrated the advantage of surgery:

First, Narbro et al. [1999] note that, at the fourth year of follow-up, the number of sick-leave and disability days is signifi cantly lower among the surgical patients than among the controls, and that these benefi ts are more pronounced for people older than 46.7 years (median age).

8. QALY (quality-adjusted life year): Calculation method allowing situations to be compared in relation to two criteria taken into account simultaneously, that is, effi cacy (number of life years gained) and the quality of life of those years.

The objective of this section is to report on the costs and the cost-effectiveness and cost-utility ratios of bariatric surgery, in light of the available scientifi c literature. The literature search was based on the results provided in the fi rst report published on this topic by AETMIS [CETS, 1998] and on an in-depth review conducted by British researchers [Clegg et al., 2002]. Since the British report took into account data identifi ed in Medline until October 19, 2001, this database was consulted to fi nd articles published until December 2004.

5.1 RESULTS OF THE ANALYSIS OF PRIMARY-DATA ARTICLES

The British report cited above identifi ed only four relevant articles [van Gemert et al., 1999; Chua and Mendiola, 1995; Martin et al., 1995; Sjöström et al., 1995]. The fi rst two had been cited in the previous AETMIS report [CETS, 1998]. Ten other more recent studies were also identifi ed [Monk et al., 2004; Potteiger et al., 2004; Sampalis et al., 2004; Snow et al., 2004; Angus et al., 2003; Gallagher et al., 2003; Ågren et al., 2002a; 2001; Nguyen et al., 2001; Narbro et al., 1999], three of which were related to the SOS study (Swedish Obese Subjects). Another article published in 2002 [Narbro et al., 2002] used the same data found in the recent study by Ågren et al., while another [Cooney et al., 2003], of more limited scope, analyzed the factors contributing to higher hospital costs incurred for the same type of surgical procedure. A detailed description of these studies can be found in Appendix H, except for the last study.

Unfortunately, none of these studies is complete enough to contribute to a valid evaluation of the cost-effectiveness or cost-utility ratio of bariatric surgery. Only one is randomized [Nguyen et al., 2001], but the analyses derived from the SOS study do present an adequate level of validity.

36

According to Ågren et al. [2002a], the surgical approach helps signifi cantly lower medication usage for obesity-related cardiovascular disease and diabetes by reducing not only the proportion of patients already under drug therapy but also that of patients required to begin such therapy (six-year follow-up). Nevertheless, weight loss has to reach at least 15% before the mean cost of total drug expenditures can decrease signifi cantly (7.8% reduction).

At six years of follow-up, hospitalization rates and costs remained signifi cantly higher for the surgical patients than for the controls. If the costs of the surgical procedure itself and the costs associated with its common problems are excluded, hospitalization costs for other problems do not differ between the two groups. In other words, at six years of follow-up, the decrease in the risk of heart disease associated with the reduction of obesity still did not translate into a reduction in hospitalization days.

Martin et al. [1995] estimate that a weight-reduction surgery program costs US$24,000 for a one-year period, while medical treatment costs US$3,000: these estimates relate only to direct health-care costs and do not include expenses resulting from complications. Furthermore, at three years, 95% of the subjects in the surgical group and 52% of those in the medical-therapy group had successfully reduced their weight by at least one third and had maintained this weight loss. However, the non-similarity of the comparison groups (especially in terms of initial weight and BMIs, age and medical history) and the large number of patients lost to follow-up weaken the validity of these outcomes.

Gallagher et al. [2003], who studied the impact of bariatric surgery on the U.S. Veterans Administration health-care system (n = 25), conclude that the costs of Roux-en-Y gastric bypass are offset by a reduction in health-care costs in the fi rst post-operative year. Mean pre-operative costs of out-patient visits (up to one

year before surgery) and hospital costs (up to three years before surgery) totalled US$10,558 per patient, while corresponding post-operative costs were reduced to US$2,840 (p = 0.005). Mean costs of peri-operative care, including eight days of hospitalization, totalled US$8,976. According to the authors, this signifi cant cost reduction, as similarly shown in other studies, would appear to be linked to a reduction in obesity-related diseases and symptoms.

Two studies comparing laparoscopic vs conventional (open) surgery conclude that the laparoscopic option offers greater cost savings [Nguyen et al., 2001; Chua and Mendiola, 1995]. According to the randomized study by Nguyen et al., hospital costs for laparoscopic gastric bypass are similar to those incurred with the conventional approach (approximately US$14,100). Operative costs were higher (p < 0.01) in the laparoscopic group, however, although they were offset by the lower costs (p < 0.02) for other hospital services, chiefl y because of shorter hospital stays and a lesser need for intensive care. In addition, subjects in the laparoscopy group were faster to return to their normal activities and work, and to attain a quality of life comparable to the one enjoyed by healthy people, according to U.S. standards (signifi cant deviations at three months). Another study, with weaker validity, was designed to analyze the specifi c issue of public and private health-care reimbursements. It indicates that laparoscopic Roux-en-Y gastric bypass costs less than open surgery (p < 0.001), despite higher direct operative costs. However, there were more complications in the laparoscopy group [Angus et al., 2003].

One particular study (not presented in the appendix) attempted to understand why certain gastric-bypass cases treated in compliance with a standardized clinical pathway were more expensive (greater than one standard deviation above the mean). The authors compared a group of 15 patients defi ned as having a cost-outlier profi le with a group of 73 patients having a normal cost profi le for total hospital care. The deviation can presumably be explained by the

37

difference in the prevalence of co-morbidities: there was a greater incidence of diabetes in the cost-outlier group (60% vs 33% ; p < 0.05), along with other severe medical conditions (60% vs 9.2%; p < 0.05), mainly sleep apnea with obesity-hypoventilation syndrome. Another factor that might explain it is that the incidence of major complications, especially gastro-intestinal and pulmonary, was also greater in the cost-outlier group (53.3% vs 7.9%; p < 0.05). Finally, the cost-outlier group had more re-admissions (46.7% vs 13%). The authors also mention that the laparoscopic procedures do not appear to cost signifi cantly more than the open-surgery procedures [Cooney et al., 2003].

Three recent studies reveal the pharmaceutical savings that bariatric surgery can achieve as a result of the resolution or improvement of the diseases associated with morbid obesity [Monk et al., 2004; Potteiger et al., 2004; Snow et al., 2004]. These three studies (described in section 4.4) were of patients who had undergone either laparoscopic or open RYGB.

According to Monk et al. [2004], the data available on 64 patients show the savings achieved in monthly medication expenditures following LRYGB: per-patient savings are estimated to be US$182, and this result is signifi cant (p < 0.01) (Appendix H). Extrapolating from these results to the nearly 75 million potentially concerned U.S. citizens, the authors estimate that total cost savings would amount to over US$100 billion per year. In a study of 51 consecutive patients,

Potteiger et al. [2004] estimated that monthly savings per patient would be US$145 (or US$1,736 per year) (p < 0.01). Considering the mean age of the study population (45 years) and projecting the medications prescribed to these patients over 30 years, the authors arrive at a total cost of US$52,080 and compare this estimate with the cost of an RYGB procedure (mean cost of US$14,700 at the medical centre in the study). This comparison does not take into account QALYs, the progression of morbid obesity

or other subsequent obesity co-morbidities (Appendix H). The authors conclude that a more detailed analysis is required. In their study of 78 patients who underwent

LRYGB, Snow et al. [2004] report a decrease in prescription-medication costs on the order of 68% as early as the fi rst year post-operatively (monthly savings of US$250 per patient) and of 72% for the second year (US$264 per patient per month). Considering that the mean cost of LRYGB is US$8,090 (US$631,000 for the 78 patients), the authors conclude that this treatment is signifi cantly more effective and economical than pharmaceutical treatments for morbid obesity and its co-morbidities, since it yielded annual savings of US$240,000 for the 78 patients. In other words, the cost of surgery is offset by the savings achieved by the end of 32 months (Appendix H).

The study conducted by Christou et al. [2004] at the McGill University Health Centre (MUHC) (described in section 4.4) also had an economic component [Sampalis et al., 2004]. Evaluated direct costs include human and material resource expenditures associated with hospital care9 and payment for medical services10. The necessary data were extracted from provincial administrative databases on hospitalizations and medical procedures and included internal MUHC data; costs are expressed in 1996 Canadian dollars. The surgical-treatment cohort incurred higher direct health-care costs in the fi rst year than did the control cohort, per 1000 patients: $12,461,938 vs $3,609,680 respectively. At fi ve years, mean cumulative costs were $19,516,667 vs $25,264,608, for a mean difference of almost $6 million per 1000 patients. Surgery costs were amortized after three and a half years.

9. Hospital costs include the costs for hospital bed use, nursing care, intensive care, food, medications, operating-room costs, diagnostic procedures, medical and surgical supplies, dietetics services and other paramedic services, including physiotherapy.

10. Medical services include out-patient visits, consultations, and medical and surgical procedures (anesthesia, surgery, psychiatric and other concerned specialties).

38

5.2 MODELLING RESULTS

Given the dearth of primary data and the lack of studies establishing valid cost-effectiveness or cost-utility ratios, two studies relied on modelling in an attempt to estimate these ratios [Clegg et al., 2002; Craig and Tseng, 2002]

5.2.1 Model developed by Clegg

The model developed by Clegg et al. [2002] compares the impact and costs of three types of surgical procedures—gastric bypass (mainly Roux-en-Y), vertical banded gastroplasty and adjustable gastric banding—with those of the non-surgical management of patients with morbid obesity. The outcomes compared include excess-weight reduction, quality-of-life gains and life-expectancy gains. Costs include only direct health-care costs: pre-operative care, surgical procedures, treatment for complications, surgery revisions and additional procedures, and follow-up. Calculations are based on the follow-up of a hypothetical cohort of 100 patients with the following characteristics: mean age of 40; 90% women; mean body weight and BMI of 135 kg and 45 kg/m2 respectively. The authors do not justify the values assigned to the variables they use. The time horizon is 20 years after surgery, and the discount rate is 6%.

Weight-reduction effi cacy scenarios are based on the data available in the literature for each of the fi rst fi ve years, after which the weight achieved is considered to be stable. The effi cacy of non-surgical treatment is assumed to be nil. After having considered different sources, the authors selected, as a quality-of-life gain measure, the utility values categorized by the patients’ ages and BMIs supplied by Roche Pharmaceuticals in its submission for approval for orlistat, a weight-loss medication. In terms of co-morbidity reduction, only diabetes was selected by the authors because studies had shown a substantial and lasting impact on this disease, while the effects on hypertension were transient, and there were insuffi cient data on the

other health problems. The impact on morbidity was measured by the reduction in treatment costs. Finally, the authors cautiously assumed no effect on life expectancy, owing to the lack of specifi c clinical data.

Cost parameters are based on published data, expert opinion, common practices in England, and unit costs established by the Scottish Health Service and by a British study. To offset their choice of fi xed values, which depend on assumptions that are often non-reproducible, the authors add a sensitivity analysis. This analysis varies hospital length of stay, pre-admission and post-admission costs, weight loss, in both the surgical and the medical scenarios, the effect of the surgical learning curve, costs associated with diabetes and utility gains.

Model results indicate that, compared with the medical option, gastric bypass, adjustable gastric banding and vertical banded gastroplasty cost £6,289, £8,527 and £10,237 respectively per QALY gained, which is lower than the £20,000 cut-off point suggested by England’s National Institute for Clinical Excellence [NICE, 2004]. The authors of this model also indicate that these ratios are lower than those of the most relevant comparators, that is, pharmaceutical treatment with orlistat or sibutramine. The different scenarios used in the sensitivity analysis help support the robustness of this conclusion. Furthermore, comparisons between the different surgical procedures still have too many uncertainties to classify any one of them as the treatment of choice. As the authors point out, the selected assumptions, which were more conservative, had an unfavourable effect on the cost-utility ratios. For example, a positive effect on life expectancy or on the reduction of related or secondary diseases other than diabetes would be associated with an improvement in these ratios, as would larger proportions of men or young adults. Furthermore, their analysis did not include non-medical benefi ts, such as productivity gains, in accordance with the recommendations in the NICE guidance.

39

5.2.2 Model developed by Craig and Tseng

In developing their model for the U.S. context, Craig and Tseng [2002] selected the perspective of the payer to estimate the cost-utility ratio of gastric bypass in relation to no treatment. They obtained this ratio by dividing the difference in total lifetime medical costs by the difference in QALYs between the two options, with a 3% discount rate. The morbidly obese population was defi ned as follows: BMI between 40 and 50 kg/m2, aged 35 to 55, non-smoker, no cardiovascular disease, drug addiction or major psychological problems, and unsuccessful medical therapy. A determinist model (decision tree) specifi ed the different rates and probabilities associated with each option, that is, life expectancy, discounted QALYs, surgical success rates, intra-operative deaths, surgery revisions and reconstructive plastic surgery (associated with complication rates), and the costs related to each possible clinical pathway. The model was based on different assumptions: for example, weight loss after a successful operation was considered to be stable at fi ve years.

Data on rates, probabilities and costs came from different single sources: for example, weight-loss estimates and complications rates were derived from a single clinical study published by Pories et al. [1995], while estimates of life expectancy and the burden of obesity (lifetime medical costs) came from a study by Thompson et al. [1998]. To estimate quality of life, the authors used national-survey data adjusted by means of a regression method and different assumptions.

In the base-case model, cost-utility ratios varied between US$5,000 and US$16,000 per QALY for women, and between US$10,000 and US$35,600 per QALY for men, depending on their ages and initial BMIs. In a few subgroups of older and less obese men, varying some key parameters infl uenced the cost-utility ratios by increasing them beyond the cut-off of US$50,000 (a reference cut-off point used by the authors, but without justifi cation). This

sensitivity analysis did not lead to appreciable changes for the other subgroups.

In summary, the authors conclude that, although gastric bypass does not lead to health-care cost savings, it has an acceptable cost-utility ratio. They indicate that their analysis has several limitations, some of which were taken into account in the sensitivity analysis, especially the fact that the weight-loss percentage was derived from a single study with a large number of patients lost to follow-up and that their QoL evaluation was not based on specifi c data. In addition, their analysis does not include patients with co-morbidities such as diabetes, cardiovascular disease or hypertension: intra-operative risks would have been greater, but so would weight-loss benefi ts. Finally, given that the study is based on the payer perspective, it excludes non-medical costs, such as those related to patients’ decreased productivity and lost wages.

5.3 COST OF BARIATRIC-SURGERY PROCEDURES

According to the estimates derived from countries where public health-care systems predominate (Australia, Netherlands, United Kingdom and Sweden), direct costs may vary between CAN$4,968 and CAN$10,870 [MSAC, 2003; Ågren et al., 2002a; Clegg et al., 2002; van Gemert et al., 1999]. This variation depends on insured costs (hospital care and physician fees, general hospital-service charges), the type of surgery, the inclusion or not of potential complications, and consideration or not of the follow-up period. It is impossible to analyze the differences in these estimates because the information is either not detailed enough or incomplete, and the organizational settings differ. According to the analyses by Clegg et al. (which include surgery revisions, re-operations, treatment for complications and follow-up) and by Australia’s Medical Services Advisory Committee (which include only the main procedure itself), the cost of LAGB is higher than that of Roux-en-Y gastric bypass (RYGB)

40

and that of vertical banded gastroplasty (VBG), whereas VBG costs less than RYGB [MSAC, 2003; Clegg et al., 2002].

According to the previous AETMIS report, the procedure performed at the Royal Victoria Hospital at the MUHC—a basic Roux-en-Y gastric bypass—would cost roughly CAN$10,500 [CETS, 1998]. According to the data provided by the bariatric-surgery follow-up committee at Hôpital Laval in 2001, the mean cost of a biliopancreatic diversion would be CAN$10,719, excluding surgeons’ fees [Comité de suivi de la chirurgie bariatrique, 2001]. Finally, the MUHC’s Technology Assessment Unit estimated direct costs for LAGB and LRYGB to be $9,418 and $7,064 respectively. These costs include the expenses associated with the surgical procedure, conversion, follow-up, complications and physician fees. The higher cost of LAGB is chiefl y due to the cost of adjustable bands [Chen and McGregor, 2004]. If general hospital-service costs were added (based on a rate of 30%), total costs would rise to $11,634 for LAGB and $8,666 for LRYGB.

In its assessment of bariatric surgery, the Medical Advisory Secretariat (MAS) of Ontario’s Ministry of Health and Long-Term Care estimates the total cost of gastric bypass or gastroplasty to be $6,185, based on 2003 fi nancial data. That amount covers only the procedure itself, not pre-operative consultations, follow-up, surgery revisions and hospitalizations due to complications. In that total, hospital costs rise to an estimated $4,890, based on a resource-use index by diagnostic category, whereas professional services (surgeon, anesthetist and surgical assistant) account for the remaining $1,295. Professional fees are added if patients have BMIs greater than 45 kg/m2, totalling $23.54 for the anesthetist and $61.30 for the surgeon. If the gastric banding were to be covered as an insured service, roughly $800 would need to be added. It is interesting to note that the Ontario Ministry of Health and Long-Term Care planned to reimburse $10,842 on average per bariatric-surgery procedure performed outside the province [MAS, 2005].

5.4 RECAPITULATION OF THE ECONOMIC EVALUATION

According to the current state of evidence, despite the limitations of the published studies and models, bariatric surgery would improve health and quality of life at rather high additional costs, but comparable to those of other medical treatments or health-care services. Its effi cacy in producing sustained weight loss is well established, and studies seem to indicate that this weight loss lowers the prevalence of co-morbidities (e.g., cardiovascular disease, diabetes) and their consequences (medication costs), reduces productivity losses caused by sick leave and disability, and improves quality of life. Bariatric surgery is a relatively expensive operation. It also leads to a certain number of complications and the need for an annual follow-up, which requires additional health-care resources. Although this point has been overlooked in the published studies, a large number of patients might also need plastic surgery after this treatment. If plastic surgery were to be deemed medically necessary, it would increase the burden of treatment costs. According to the model by Clegg et al. [2002], the net cost of surgery to treat morbid obesity (i.e., taking into account the savings attributable to diabetes control) would total between CAN$22,000 and CAN$24,700 over a 20-year period. By comparison, a less effi cacious treatment program would cost a net total of CAN$15,925. Although bariatric surgery seems cost-effective, it is still necessary to conduct well-designed economic studies and to be able to rely on longer-term actual data not only on effi cacy and quality of life but also on resource-utilization costs (or savings). Similarly, studies are needed to solidly establish the impact and relative costs of the different surgical approaches, especially laparoscopy, given that this technique is rapidly becoming widespread and the follow-up period associated with this technique remains less than fi ve years.

41

6 REVIEW OF THE VARIOUS HEALTH-TECHNOLOGY ASSESSMENT REPORTS

6.1 BARIATRIC SURGERY no clinical or psychological contra-indications to surgery under anesthesia. In addition, patients must agree to long-term follow-up. The choice of surgical technique depends on patient preferences and characteristics and on the surgeon’s learning curve.

In its latest clinical practice guidelines on the management of patients with morbid obesity, Australia’s National Health and Medical Research Council [2003] considers that bariatric surgery is the treatment of choice for these patients when all other therapeutic approaches have failed. The NHMRC adds that this treatment must take place under strict medical and nutritional follow-up.

From its systematic review of the literature published between 1992 and 2002, the Basque agency Osteba concludes that purely restrictive surgical techniques are safer, although their long-term effi cacy is weak. Conversely, procedures inducing malabsorption have greater risks of complications and a steeper learning curve. They nevertheless yield better weight-loss outcomes. Osteba considers that, “in light of available data, gastric bypass may be the procedure that best balances safety and effi cacy, that restrictive procedures should be reserved to a select subgroup of patients, and that super-obese patients may benefi t from a technique that includes induced malabsorption” (Free translation) [Rico Iturrioz et al., 2003]. These conclusions support the fi ndings of its prior report, which examined the effi cacy of the main techniques in use (vertical banded gastroplasty, gastric banding and Roux-en-Y gastric bypass), while pointing to the contextual elements to be taken into consideration, that is, the learning curve and multidisciplinarity of the team in charge of the procedure as well as patient characteristics [Egino Sasiain et al., 2000]. In a similar vein, Osteba suggests that all surgical cases of morbid obesity be regularly recorded in

The literature review performed by the Agence Nationale d’Accréditation et d’Évaluation en Santé [2001] in France considered different reports published worldwide on the surgical treatment of morbid obesity: Scottish Intercollegiate Guideline Network, 1996; Centre for Review and Dissemination, University of York, 1997; National Health Services, 1997; National Heart, Lung and Blood Institute, 1998; and the Conseil d’évaluation des technologies de la santé, 1998. The ANAES selected three types of procedures for its evaluation: vertical banded gastroplasty, adjustable gastric banding and gastric bypass.

While acknowledging the place occupied by bariatric surgery in the management of morbid obesity and the sharp rise in the number of surgical procedures, the ANAES concludes that, “when the indication is correctly diagnosed, vertical banded gastroplasty and gastric bypass present an acceptable risk-benefi t ratio. The same holds true for gastric banding, based on its short-term evaluation” [Free translation]. Nevertheless, this agency emphasizes that each technique leads to specifi c complications that may sometimes impair the patient’s vital prognosis. The ANAES points to the lack of long-term follow-up that does not permit evaluation of the actual incidence of late complications from gastric banding. Consequently, it deplores the fact that this technique is being put into widespread use without ever having been subject to evaluation.

The National Institute for Clinical Excellence [2002] in Great Britain recommends bariatric surgery for people over the age of 18 who have morbid obesity, who are followed up by a bariatric specialist in a hospital centre and who have been unsuccessfully treated with other non-surgical therapeutic options. Patients must have

42

order to provide better patient care by offering an appropriate choice of procedure based on patient characteristics. This registry would also help evaluate the advisability of introducing new surgical techniques.

In a synthesis study on the effi cacy of pharmacotherapy, counselling or behaviourist approaches and surgery for the treatment of obesity, which was prepared for the U.S. Preventive Services Task Force, McTigue et al. [2003] found certain limitations in previous systematic reviews:

They have widely differing eligibility criteria, treatment classifi cations and data-synthesis methods; Aggregate values of their fi ndings do not

refl ect the variations in sample size, follow-up periods, and treatment differences that are found in randomized comparative rials.

Despite the limitations of these studies, McTigue et al. point out that they did achieve consistent fi ndings. They conclude that only surgery permits signifi cant long-term weight loss, even if it is associated with a low risk for severe complications. Body size, health status, and prior weight-loss history may all infl uence the choice of appropriate treatment.

In its review of the evidence on the effi cacy of pharmacological and surgical treatments for obesity, the U.S. Agency for Healthcare Research and Quality (AHRQ) concludes that bariatric surgery is more effective than currently available non-surgical treatments for patients with BMIs greater than 40 kg/m2. Surgery also translates into improved health outcomes (reduced diabetes and sleep apnea, and better quality of life). Although the data seem to indicate that it leads to sustained weight loss in patients with BMIs between 35 and 40, they are not conclusive enough and further studies are required. Despite the scarcity of comparative studies on the different techniques, the AHRQ affi rms that Roux-en-Y gastric bypass (RYGB), vertical banded gastroplasty (VBG) and adjustable gastric banding (AGB) bring about substantial weight loss, but that

RYGB seems more effi cacious than VBG for people with BMIs greater than 40. This assessment agency nevertheless suggests that the various techniques may result in considerably different complications and adverse effects. In addition, the proportion of patients experiencing complications may be quite large, greater than 20% (although most are minor in severity). A post-operative mortality rate of less than 1% has been achieved by a fair number of surgeons and bariatric-surgery centres, although it may be higher in other settings. The authors recommend that randomized controlled trials be performed to compare the effi cacy and safety of the different types of surgical procedures and that well-designed comparative studies (with pharmacological and behaviourist approaches) be conducted to study the effects of bariatric surgery on obesity co-morbidities. These conclusions are based on 245 studies published until 2003 (78 on medical therapy and 167 on bariatric surgery) [Shekelle et al., 2004].

The Ontario assessment agency recently published its fi ndings from its analysis of 15 systematic reviews or assessment reports and English-language articles on bariatric surgery published between July 2002 and September 2004. In its conclusions, the Medical Avisory Secretariat (MAS) confi rms the effi cacy of surgical treatment in general for patients with BMIs greater than or equal to 40 kg/m2 or with BMIs greater than or equal to 35 in the presence of co-morbidities (major weight being given to the evidence in the SOS study). It also confi rms that malabsorptive techniques are superior to restrictive ones. However, the lack of solid evidence cross-comparing the different techniques does not allow it to pass judgment on the superiority of any one of them. In that regard, no conclusion is drawn on laparoscopic or open approaches [MAS, 2005]. The Ontario Health Technology Advisory Committee (OHTAC), which guides and approves the work of the MAS, is responsible for the recommendations derived from MAS systematic reviews. In terms of bariatric surgery, the OHTAC endorses the conclusion regarding

43

its effi cacy and recommends the development of detailed selection criteria and the establishment of centres of excellence. These centres should be properly equipped to accommodate patients who are severely obese and should have an interdisciplinary team of specialists to conduct pre-operative assessments and post-operative follow-up for those patients. Moreover, these centres should offer gastric banding as an insured service. Finally, the OHTAC recommends that the particular type of bariatric procedure should be chosen after a surgeon–patient discussion that includes examination of the risks and benefi ts of each procedure.

6.2 LAPAROSCOPIC SURGICAL PROCEDURESIn its 2001 assessment report, the Alberta Heritage Foundation for Medical Research (AHFMR) concludes that laparoscopic bariatric surgery is still in its “learning stage” and that this approach requires two types of expertise: bariatric-surgery skills and laparoscopic skills. Reported complications and the lack of long-term follow-up make it diffi cult to foresee the impact that this technique might have on the management of obese patients [Hailey and Harstall, 2001].

In its April 2000 report, the Australian Safety and Effi cacy Register of New Interventional Procedures – Surgical (ASERNIP-S), while drawing attention to the lack of valid comparative data, points out some of the potential benefi ts of laparoscopic procedures. Its assessment specifi cally covered laparoscopic adjustable gastric banding and indicated that the mean length of surgery was generally less than two hours, and the mortality rate less than 1 in 1000. The morbidity rate was similar to that of the other types of procedures, the hospital stay was shorter, and quality of life better. The long-term effi cacy of this surgical technique remains to be demonstrated [Chapman and Kiroff, 2000]. In a second report published in June 2002, the ASERNIP-S reiterated its conclusions, while expressing reservations about the superiority

of Roux-en-Y gastric bypass (RYGB) over laparoscopic adjustable gastric banding (LAGB) for weight-loss maintenance in the medium term (from two to four years). This organization stresses the need for randomized controlled trials and longer-term follow-up [Chapman et al., 2004].

Following the report by the ASERNIP-S and in the context of the steadily rising number of bariatric surgeries, the Australian Minister for Health and Ageing (through the Medicare Benefi ts Branch) asked the Medical Services Advisory Committee (MSAC) to assess the effi cacy and safety of LAGB (Lap-Band device). The comparators used for this assessment were RYGB, the current gold standard, and vertical banded gastroplasty (VBG), the most commonly performed procedure in Australia. According to their report, LAGB may eventually replace VBG. For its analysis, the MSAC selected 174 studies and three health-technology assessment reports published up to July 2002. In its conclusions, the MSAC fi rst indicates that LAGB is as safe as the other procedures. In terms of weight loss, LAGB is less effi cacious than RYGB, but as effi cacious as VBG, although preliminary evidence seems to indicate that LAGB maintains weight loss for a longer period. Even if LAGB costs more than the comparators, the incremental cost-utility ratio is considered acceptable. On the strength of these fi ndings, the MSAC recommends that this procedure continue to be publicly funded [MSAC, 2003].

In a report published in 2003, the Technology Evaluation Center (TEC) at the Blue Cross and Blue Shield Association examined the most recent bariatric-surgery techniques. The assessment was based on the following specifi c criteria: fi nal approval from a government regulatory body for the technology used, conclusive scientifi c evidence on the impact of the technology on health outcomes, improvement in the net health outcome, superior or equivalent benefi ts by comparison with other established techniques, and the reproduction of the last two effects in current practice. The techniques considered established were RYGB,

44

VBG, horizontal gastroplasty, and AGB. In light of its analysis, the TEC concludes that laparoscopic gastric bypass and vertical banded gastroplasty, as well as biliopancreatic diversion, and distal or long-limb gastric bypass, do not meet its criteria and are therefore not eligible for coverage [BCBS, 2003b].

In its most recent clinical policy bulletin, the U.S. insurer AETNA [2004], after analysis of evidence-based clinical information, concludes that RYGB is medically necessary (and therefore eligible for coverage). The same applies to VBG and LAGB, but only for patients who are at increased risk of complications from RYGB, owing to the presence of any of the following co-morbid medical conditions: hepatic cirrhosis, chronic infl ammatory bowel disease, radiation enteritis, demonstrated complications from extensive adhesions involving the intestines from prior major abdominal surgery, poorly controlled systemic disease. Some of the procedures expressly excluded from coverage, owing to a lack of suffi cient evidence, are loop gastric bypass, horizontal gastroplasty, BPD-DS, BPD (Scopinaro), along with LAGB and VBG, except for the previously mentioned specifi c indication (at-risk patients).

In a report released in April 2004, the Technology Assessment Unit of the McGill University Health Centre (MUHC) published its assessment of laparoscopic adjustable gastric banding (LAGB) (Swedish adjustable gastric band). This study relied on the report by the Australian agency ASERNIP-S [Chapman et al., 2004] and selected 19 additional studies published between May 2001 and February 2004. The selected comparator was LRYGB. The authors conclude that, according to the data from a follow-up period covering up to fi ve years, LAGB is effective (in terms of excess weight loss) and safe, with complication and mortality rates comparable to, if not lower than, those of RYGB. This procedure, however, costs 39% more than its comparator. However, so long as this procedure is not approved and partially covered by the Québec government, it recommends that the MUHC not use it except in special cases, and only after consultation with the surgeon. Furthermore, even if the government did approve LAGB, it would be necessary to demonstrate its long-term clinical superiority before the MUHC would accept it as the procedure of choice [Chen and McGregor, 2004].

45

7 DISCUSSION

international survey, RYGB accounted for 85% of the operations performed in the United States and Canada in 2003, while VBG represented only 1.4% of the procedures [Buchwald and Williams, 2004; Fisher and Schauer, 2002]. This technique is performed more often in other countries, such as Sweden, Poland, Greece, Italy and Egypt. The international survey estimates that VBG accounted for 5.43% of the procedures. The major reason is that VBG is a purely restrictive technique, whereas RYGB combines restriction and induced malabsorption. American surgeons have pointed out that VBG produces unsatisfactory outcomes in terms of sustained weight loss, re-operation rates and adverse events such as gastro-esophageal refl ux and inability to tolerate solid food [Balsiger et al., 2000; Mason et al., 1992; Sugerman et al., 1987]. Belachew12 adds that a very high rate of vertical-staple disruptions has been observed. Moreover, in Australia, laparoscopic adjustable gastric banding (LAGB) is quickly supplanting VBG: according to the international-survey data, the number of LAGB procedures reached 80% in 2003.

In the case of biliopancreatic diversion (BPD), there are fewer assessments and long-term follow-up. As a general rule, this lack is due to the technical requirements for this type of procedure or to the fact that this practice is limited to specifi c institutions, or to both factors. It is important to point out the similarity between long-limb Roux-en-Y gastric bypass and Scopinaro’s biliopancreatic diversion. The characteristics shared by these two procedures have led some authors to underestimate or overestimate the number of BPD procedures, depending on whether or not they consider this type of RYGB to be a biliopancreatic diversion. Over the past few years, use of the laparoscopic variations of these procedures (gastric resection

12. Written personal communication, April 5, 2004.

Among the different techniques, gastric bypass is the most frequently performed procedure (Table 13). The American Society of Bariatric Surgery estimates, from data obtained from its members, that 103,200 bariatric surgeries11 were performed in 2003, and that this fi gure reached 140,640 in 2004 [Colwell, 2005]. Practitioners have diverging opinions on biliopancreatic diversion (BPD) because of its technical complexity and problems linked to malabsorption, especially if patient management is inadequate (e.g., vitamin defi ciencies or malnutrition).

In Québec, fi fteen or so surgeons perform surgical procedures to treat morbid obesity. Current bariatric centres are located in Montréal, Quebec City, Sherbrooke, Longueuil, Val-d’Or and Drummondville. Surgical techniques used are:

gastric bypass; vertical banded gastroplasty; biliopancreatic diversion; adjustable gastric banding (Lap-Band).

Currently, the effi cacy and safety of vertical banded gastroplasty (VBG) and Roux-en-Y gastric bypass (RYGB) are well established (follow-up > 15 years). However, most bariatric-surgery specialists consider RYGB to be the gold standard and the comparator of choice in most comparative studies in the fi eld. The latest data from an international survey (26 out of 31 countries responded to the survey) indicate that gastric bypass (mostly different versions of RYGB) accounts for 65.11% of the total number of procedures [Buchwald and Williams, 2004].

For its part, VBG is quickly losing impetus, especially in the United States, and is being increasingly replaced by RYGB. According to an

11. This estimate is close to the one by Pandolfi no et al. [2004], who report a fi gure closer to 100,000.

46

and other combined methods) has become more frequent, but these techniques remain limited to some surgical teams and are currently under assessment.

It is worth mentioning that the World Health Organization [2003] states that it has yet to see an in-depth assessment of the safety and long-term effi cacy of biliopancreatic diversion and of the laparoscopic versions of restrictive techniques (e.g., adjustable gastric banding) and mixed techniques. Intestinal bypass is not recommended as a fi rst-line surgical treatment for obesity.

In the CETS report [1998] on the surgical treatment of morbid obesity, biliopancreatic diversion with duodenal switch (BPD-DS) had been classifi ed as an experimental technology (see Appendix A for the classifi cation of health technologies). Technological advances, the number of surgical patients, the length of follow-up for surgical patients and published fi ndings have led to recognizing this technique as effective: it contributes to sustained weight loss comparable to that achieved by other technical procedures, and even better in some cases, according to some authors. Although this technique is no longer considered experimental,

too few comparative studies have been done so far, leaving a number of points that still need clarifi cation with respect to its most appropriate indications and its place among the range of bariatric techniques for treating morbid obesity.

In addition, biliopancreatic diversion, along with its variant—biliopancreatic diversion with duodenal switch (BPD-DS)—is still not widely used since it represents only 4.85% of the procedures performed worldwide, according to the international survey by Buchwald and Williams [2004]. In actual fact, BPD-DS is performed by only 128 surgeons around the world,13 including one team in Québec. Its relatively low use is related more to surgeons’ belonging to a particular “school” and/or to their experience than to concerns about its effi cacy. As a few authors have pointed out, insurers’ different decisions and even lack of clear policies on covering this procedure (except for the Blue Cross and Blue Shield Association) show that the problem is not related to the outcomes achieved with this technique but to the fact that it is used infrequently. For example, in its assessment of the surgical treatment of morbid obesity, the ANAES [2001] excluded BPD-DS because it is rarely performed in France and elsewhere in Europe.

13. Personal communication from Dr. N. Scopinaro, April 7, 2004.

TABLE 13

Types of procedures performed by the members of the International Bariatric Surgery Registry

TYPE OF PROCEDURE* RELATIVE SHARE

Gastric bypass Roux-en-Y gastric bypass (and variants) Other gastric bypass procedures (with transverse dissection of stomach)

“Simple” procedures Vertical banded gastroplasty Silicone banded gastroplasty Others

“Complex” procedures: biliopancreatic diversion, ileogastrectomies, etc.

71%(48%)(23%)21%

(12%) (8%) (1%) 8%

Source: IBSR, 2001 (data confi rmed on June 7, 2004).* No distinction is made between open and laparoscopic procedures.

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Laparoscopic bariatric surgery is becoming increasingly used to treat morbid obesity. Numerous studies on this topic have been published, but to date too few randomized clinical trials have been conducted to assess the effi cacy or safety of this technique compared with other types of open bariatric surgery, especially Roux-en-Y gastric bypass, which has become the gold standard. Most of the studies on this approach do not yet have a long enough perspective (generally less than fi ve years) to be able to assess its level of weight-loss maintenance or the incidence of late complications. Nevertheless, the clinical profi le for this procedure, including elements such as a low operative risk, an acceptable morbidity rate and reversibility, makes it a promising procedure for the management of morbid obesity, even though a certain number of complications directly linked to the laparoscopic approach have yet to be resolved.

According to the international survey by Buchwald and William [2004], 62.85% of the procedures performed worldwide in 2003 were done laparoscopically: gastric bypass LRYGB accounted for 34.59% of them, and adjustable gastric banding (LAGB) for 24.16%. These data indicate that 45% of all RYGB procedures are done laparoscopically in North America (United States and Canada). Furthermore, the approval of LAGB (Lap-Band) in June 2001 by the U.S. Food and Drug Administration (FDA) opened the door to the rapid proliferation of this technology. In Canada, three devices have been approved and are commercially available. No province has yet agreed to specifi cally cover this laparoscopic technique [Chen and McGregor, 2004], even though the OHTAC recommended in 2005 that it become an insured service [MAS, 2005]. In Europe, LAGB is the most frequent type of procedure. As a point of illustration, a national survey in France found that this procedure accounted for 88.3% of all bariatric surgeries [CNAMTS, 2004].

The rapid spread of this technology has led several authors to raise questions about the consequences related to the learning curve, which permits surgeons to acquire the necessary expertise to perform this technique in all

safety. In a recent study of 600 consecutive patients treated surgically for morbid obesity (LRYGB with hand-sewn sutures), Ballesta-Lopez et al. [2005] noted that most outcome measures (length of surgery, complication rate, conversion rate, and mortality rate) improved with the number of procedures performed. The worst outcomes were documented for the fi rst 100 surgical patients. These fi ndings confi rm the conclusions of other authors, who have stated that the improvement curve for these outcome measures reaches a plateau between 75 and 100 procedures [Oliak et al., 2003; Schauer et al., 2003b; Papasavas et al., 2002].

The relationship between the volume of procedures and the incidence of complications has also been demonstrated in an analysis of hospital-discharge data in the state of Pennsylvania [Courcoulas et al., 2003b]. Among the 4685 patients who underwent gastric bypass, 28 deaths (0.6%) and 813 adverse outcomes (17.4%) were documented. For surgeons who performed fewer than 10 operations per year, the risk of adverse outcomes was 28% and the risk of mortality was 5%, compared with 14% (p < 0.05) and 0.3% (p < 0.06) respectively for higher-volume surgeons. Although the relationship between adverse outcomes and hospital volume did not reach signifi cance, the authors nevertheless noted that surgeons who treated from 10 to 50 cases per year had a 55% risk of adverse outcomes. These fi ndings argue in favour of concentrating bariatric surgery in centres that are well equipped and able to rely on experienced surgeons.

Regardless of the satisfactory outcomes published for each surgical technique studied individually, the diversity of the characteristics of patients with morbid obesity and the inadequate number of well-designed comparative studies do not yet allow one technique to be systematically favoured over the other. The outcomes associated with a given surgical technique depend to a great extent on the following factors (other than its intrinsic value, the surgical learning curve and the patient’s personal preference):

exclusion of patients at risk of post-operative complications;

48

psychological preparation;

clinical preparation: for example, at the Mercy and Unity Hospital in Minneapolis, which set up a bariatric centre for patients with morbid obesity (36 bariatric surgeries per month, mean length of stay from two to three days, and mortality rate less than 1%), potential patients are “requested” to lose 10% of their excess weight before surgery, which could be a way of evaluating how determined they are to reach the objectives set by their treating physicians; acceptance of long-term, if not lifelong,

follow-up.

The treatment of super-obese patients presents several challenges that can be overcome by some of the surgical techniques evaluated, including RYGB, VBG-RYGB, and biliopancreatic diversion. More recent data reveal the fi rst promising experiences with LRYGB for patients with BMIs greater than 50 kg/m2 and even 70 kg/m2 [Dresel et al., 2004; Kreitz and Rovito, 2003]. In addition, as a result of a trial conducted with patients with BMIs greater than 60, a group from the Mount Sinai School of Medicine (New York) suggest that this procedure be performed in two stages: a sleeve gastrectomy followed by RYGB from six to nine months later [Regan et al., 2003].

There appears to be a growing reliance on consensus for developing standards for assessing the quality of surgical procedures in this particular fi eld: in the United States, a post-operative leak rate from 1% to 2% and a rate of infectious wounds less than 5% in operated obese patients are considered “usual” values for this type of procedure. The same is true for hospital stays from 2.5 to 4 days (laparoscopy) and from 3.5 to 4 days (open surgery).

As a general rule, as emphasized by the ANAES [2001], no surgical technique may be considered harmless, and recommendations must be strictly followed (surgeon’s learning curve with the technique, appropriate clinical setting, management by a multidisciplinary team, and long-term medical follow-up). Many authors stress that bariatric surgery performed by inexperienced surgeons or the lack of strict,

long-term follow-up may lower the quality of patient management.

A further aspect involved in patient management concerns the impact of signifi cant weight loss, given that it may require reconstructive plastic surgery. Although the present assessment has not examined this issue, recommendations for effective bariatric surgery specify that therapeutic treatment plans must include this aspect [Mouïel et al., 2004]. A recent report from the Scottish Executive Health Department [2004] confi rms this recommendation by emphasizing that plastic surgery is an integral part of an overall bariatric-surgery management program and, consequently, patient selection criteria must be clearly defi ned. Plastic surgery restores body image and contributes to psychological healing; however, it must be considered only after patients have achieved a stable weight, at least 12 months after bariatric surgery.

Finally, the techniques for treating morbid obesity have been constantly evolving, as shown by the application of robotics to bariatric surgery and the use of gastric stimulators to promote weight loss. Preliminary results from the use of a Da Vinci robot to perform a laparoscopic Roux-en-Y gastric bypass procedure seem encouraging, although its long-term benefi ts and drawbacks require further investigation [Mohr et al., 2005]. Gastric stimulators, one type of which has already been approved in Canada, are surgically implantable devices that send electrical impulses to the abdominal-wall muscles causing different reactions that lead to reduced appetite and a rapid sensation of satiety. Despite positive weight-loss outcomes, more studies are required to better understand their mechanism of action and to identify the type of patient who would benefi t from this device [Cigaina, 2004; De Luca et al., 2004]. It would therefore be advisable to implement a horizon-scanning system to track the evolving status of these new techniques, especially because one of them, gastric simulation, is the subject of trials at the McGill University Health Centre in Montréal.14

14. Information taken from http://www.weightlosssurgery.ca/en/surgery.php (accessed on September 9, 2005).

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8 CONCLUSION

The choice of surgical technique depends on a number of factors:

Patient characteristics: age, personality, BMI, food patterns, personal understanding and commitment, co-morbidities, contra-indications; Reversibility or non-reversibility of the

technique; Risks linked to each technique (e.g., wound

dehiscence, hernias, device slippage, staple-line disruption); Potential effects of nutritional defi cits; Availability of human and material resources; Support provided by the expertise of a

multidisciplinary team; and Surgical team’s experience in both general

and specifi c terms: for example, laparoscopy requires great dexterity and therefore involves a rather steep learning curve.

Although the laparoscopic approach raises specifi c issues, which are described further on, examination of the evidence on the main techniques used in Québec lead to the following observations:

Roux-en-Y gastric bypass (RYGB): This technique has established effi cacy in terms of stable weight loss, a low complication rate and a positive impact on co-morbidities. For most bariatric specialists, it has become the gold standard. It is the most commonly used technique in the general group of gastric-bypass procedures.

Vertical banded gastroplasty (VBG): Although this technique has established effi cacy, it has achieved lower than expected weight loss and has lost favour with North American surgeons. Combined with RYGB, VBG yields good long-term results.

This analysis of the various studies and assessment reports currently available on the surgical treatment of morbid obesity leads AETMIS to make the following conclusions.

8.1 GENERAL ROLE OF BARIATRIC SURGERYSurgical treatment is recognized today as a more effective therapeutic option than non-surgical treatment for patients who are morbidly obese. Although most of the evidence refers to short-term outcomes, several studies are beginning to demonstrate long-term sustained weight loss. Surgery itself has some potentially serious complications. Although these adverse effects are generally managed appropriately, they require continual assessment.

Even if bariatric surgery continues to be an expensive procedure, the weight loss that results decreases the prevalence of co-morbidities (e.g., cardiovascular disease and diabetes) and their consequences (prescription drug spending), reduces productivity losses caused by sick leave and disability, and improves quality of life. Nevertheless, the favourable cost-effectiveness (or cost-utility) ratio and the effi ciency suggested by the current state of the evidence need to be confi rmed by longer-term well-designed economic studies.

8.2 THE DIFFERENT SURGICAL TECHNIQUESAlthough bariatric surgery relies on a wide range of techniques, current evidence does not yet favour one over the other, owing to the variety of contexts in which they are performed, the diversity of patient characteristics and the lack of well-designed comparative tudies. Moreover, a single procedure may involve several techniques.

50

Adjustable gastric banding (AGB): This technique is generally recognized as being effective in terms of both weight loss and low complication rates. It has the advantage of being reversible and is increasingly replacing VBG.

Biliopancreatic diversion with duodenal switch (BPD-DS): Despite the fact that this technique is used only in a few centres because of its stringent requirements for post-operative patient management and follow-up, its long years in use (over 20 years), the cumulative number of procedures performed to date and its positive weight-reduction outcomes mean that this pro cedure is no longer considered experimental. In addition, some studies suggest that BPD-DS would be appropriate for super-obese patients.

Laparoscopic bariatric-surgery techniques have been developing at a rapid pace and have spread to a growing number of countries.

Compared with conventional surgical techniques, laparoscopic procedures offer many advantages. They reduce hospital stays and decrease, if not eliminate, complications associated with open surgery; however, they do have other types of complications. Recall that surgeons must train in the best conditions to master this approach.

Given that the Roux-en-Y gastric bypass procedure (RYGB) is well advanced and recognized as the gold standard in its open version, laparoscopic RYGB may be considered an innovative procedure. The two approaches yield the same effects at one year of follow-up, and their range of short-term complications differs only slightly. However, longer-term comparative data are still required.

Adjustable gastric banding (LAGB) may also be considered an innovative technology. Not only is this technique reversible, it also appears safe and effi cacious (in terms of

excess weight loss): major complications are rare and its complication and re-operation rates are acceptable. Although an Australian assessment agency recommends that this technology be covered by the public-health system, other agencies, while recognizing its effi cacy, specify that well-designed comparative studies based on longer follow-up periods (more than fi ve years) are required to confi rm its outcomes.

As for the other laparoscopic techniques, it remains necessary to closely monitor patients, to identify their indications more clearly and to pursue more research in this fi eld with solid long-term comparative studies. They must still be classifi ed as experimental, owing to the uncertainty that continues to surround their effi cacy and safety.

8.3 CHALLENGES FOR QUÉBEC’S MEDICAL PRACTICE Different bariatric-surgery techniques are currently being used in Québec by highly experienced surgeons in the fi eld. Yet there is a lack of data on the quality and effec tiveness of these procedures and on the population of treated patients. The supply of services also appears insuffi cient, given the steady growth of waiting lists and waiting times. In such a context:

it is crucial to know and share all the different information about the treated population and the outcomes achieved in bariatric-surgery centres;

it is necessary to effectively measure the evolution and extent of bariatric-surgery needs resulting from the growing prevalence of morbid obesity;

it is advisable to promote the development of practice guidelines on the management of patients with morbid obesity in order to ensure that service offerings are of high quality.

51

Following a meeting of an ad hoc committee on bariatric surgery, the Québec Association of General Surgeons (QAGS) developed a policy on the surgical treatment of morbid obesity.15 This policy contains fi ve key points:

1. Surgeons wishing to perform this surgery must work in conjunction with an interdisciplinary team. The members (QAGS ad hoc committee) are of the opinion that it is crucial that this team include anesthetists and internists (endocrinologists – pneumologists). It is strongly advised that nutritionists and psychologists be part of the team. A bariatric nurse could ultimately join the team.

2. In the current state of affairs, we do not believe that all surgeons will set up a bariatric-surgery practice. It is possible, however, that a surgeon, in a peripheral or even remote hospital centre, would want to perform this type of procedure.

15. Québec Association of General Surgeons (QAGS), written communication, March 21, 2005.

That is why it would be benefi cial for the surgeon to become affi liated to a reference hospital, upon which the surgeon could rely on for advice or in the event of a problem. These centres could be defi ned in relation to bariatric-surgery volume.

3. It is important that residents in training be made aware of and even trained in this surgical practice in the same way as any other surgical procedure.

4. Independent training sessions or even continuing medical-education activities will be encouraged and promoted in a bid to raise awareness among all surgeons, thereby giving surgeons interested in this fi eld the opportunity to perform this type of surgery.

5. It would be to surgeons’ advantage to inform their departmental colleagues of the establishment of a bariatric-surgery practice.

52

9 RECOMMENDATIONS

Have an experienced multidisciplinary team capable of supplying the full range of care and services tied to this type of treatment: surgical team, psychologist, nutritionist, medical specialists (e.g., diabetologists, cardiologists, pneumologists).

Provide closely monitored lifelong follow-up, and cover the physical and psychological dimensions of this treatment, which consequently includes consultations linked to the need for plastic surgery.

3) It is recommended that a Québec registry on morbid obesity and its management be established. This registry will offer key support in implementing a regional follow-up program for operated patients by linking the different health-care structures (hospitals, health centres) and by including specifi c patient education on nutritional approaches appropriate for this type of patient. This data source will make it possible to determine the prevalence and categorization of the different patients, to evaluate the surgical procedures that are currently being performed and to rule on the new bariatric-surgery approaches.

1) It is recommended that the Ministère de la Santé et des Services Sociaux and other decision makers concerned with the problem of morbid obesity identify current and future needs in bariatric surgery, establish an action plan to increase the capacity to provide this treatment, and ensure that patients in the different settings and regions have fair access to these services.

2) It is recommended that, at the organizational level, all hospital bariatric-surgery programs comply with the conditions listed below, which will be subject to a quality-assurance process. Such programs must:

Establish a strict patient-selection process (e.g., patients who have BMIs of 40 kg/m2 or more, or 35 with co-morbidities, who have acceptable operative risks, who are motivated and well informed of the inherent risks of the procedure and of the need for lifelong follow-up) and a system for prioritizing patients on scheduled waiting lists.

Have available facilities and equipment adapted to the specifi c profi le of the patients concerned (e.g., recovery rooms, intensive- care units, beds and furniture, diagnostic investigation tables, operating tables, and adapted surgical instruments).

53

ABBREVIATIONS USED IN THE APPENDICES

AGB Adjustable gastric banding (open procedure)

AHAL Ad hoc alimentary limb

AHS Ad hoc stomach

ALOS Average length of hospital stay

AOT Average operating time

BAROS Bariatric Analysis and Reporting Outcome System

BMI Body mass index

BPD Biliopancreatic diversion (open procedure)

BPD-DS Biliopancreatic diversion with duodenal switch

CI Confi dence interval

CVD Cardiovascular disease

EWL Excess weight loss

F Females

GB Gastric banding

GBP Open gastric bypass

GERD Gastro-esophageal refl ux disease

LAGB Laparoscopic adjustable gastric banding

LBPD Laparoscopic biliopancreatic diversion

LGBP Laparoscopic gastric bypass

LRYGB Laparoscopic Roux-en-Y gastric bypass

LSAGB Laparoscopic Swedish adjustable gastric banding

LVBG Laparoscopic vertical banded gastroplasty

M Males

MO Morbid obesity

N Number of patients

NCC Non-controlled non-randomized comparative study

NS Non-signifi cant difference

O Obese patients

OR Odds ratio

P Prospective non-comparative study

54

PCC Prospective, controlled, non-randomized comparative study

PNCC Prospective, non-controlled, non-randomized comparative study

R Retrospective non-comparative study

RC Randomized comparative study

RNCC Retrospective, non-controlled, non-randomized comparative study

RR Relative risk

Rx Prescribed medication

RYGB Open Roux-en-Y gastric bypass

SAGB Swedish adjustable gastric banding

SO Super-obese patients

SOS Swedish Obese Subjects Intervention Study

T Total

VBG Open vertical banded gastroplasty

VBG-RYGB Vertical banded gastroplasty combined with Roux-en-Y gastric bypass

55

APPENDIX A

STATUS OF HEALTH TECHNOLOGIES: AETMIS CLASSIFICATION

AETMIS has developed the following classifi cation to identify the status of health technologies under review [CETS, 1998]:

Experimental status

The term experimental will be used here to describe a procedure whose effectiveness has yet to be established. Such a procedure should therefore not be used in health-care facilities, except in the context of research projects.

Innovative status

The term innovative will be used to describe a technology which has passed the experimental stage and whose effectiveness has been established. However, because of a lack of experience, certain indications for its use and various aspects of its application are not yet clearly defi ned. To gain further knowledge of such technology, it would be important to gather systematically all the information acquired from its utilization and to communicate it to the medical community in the form of a clinical research report or systematic review or to an appropriate registry. To further these objectives and to prevent its premature widespread use, such technology should be restricted to certain authorized university hospitals which have the necessary resources and knowledge.

Accepted status

The term accepted will describe a well-established technology for which there is a long history of use and a knowledge of, or failing that, universal acceptance of its effectiveness in all its applications.

56

APPE

ND

IX B

OU

TCO

MES

OF

STU

DIE

S O

N V

ERTI

CAL

BAN

DED

GAS

TRO

PLAS

TYTA

BLE

B-1

Lap

aros

copi

c ve

rtic

al b

ande

d ga

stro

plas

ty

AUTH

OR

SN

UM

BER

O

F PA

TIEN

TS

BM

I(K

G/M

2)

FOLL

OW

-UP

(MO

NTH

S)AO

T(M

IN)

ALO

S(D

AYS)

EAR

LY

COM

PLIC

ATIO

NS

MO

RTA

LITY

R

ATE

(%)

LATE

CO

MPL

ICAT

ION

S*

OU

TCO

MES

Alle

et a

l.,19

98(R

)26

143

.328

102

41.

9%0.

4 (1

pul

mon

ary

embo

lism

)5.

7%EW

L: 7

5% a

t 18

mon

ths

Näs

lund

et a

l., 1

999

(P)

6044

.4 ±

1.0

23 ±

1.5

85–2

253

6.7%

1.7

2.2%

R

e-op

erat

ions

: 25

%

(15

case

s)

BM

I at 3

6 m

onth

s (N

S):

LVB

G: 3

7.0

kg/m

2 (2

5.8–

53.3

)V

BG

: 36.

9 kg

/m2

(24.

6–50

.7)

Salv

alet

al.,

199

9 (R

)87

43.8

6–18

Unspecifi ed

Unspecifi ed

12.6

%1.

157.

4%EW

L: 7

5% a

t 18

mon

ths

Topp

ino

et a

l., 1

999

(R)

170

43.9

1–36

95

Unspecifi ed

4.7%

04.

0%R

e-op

erat

ions

: 0.

6%EW

L: 6

1% a

t 36

mon

ths

* La

te c

ompl

icat

ions

incl

ude

absc

esse

s, le

aks, fi s

tula

s, pu

lmon

ary

embo

lism

s, st

enos

es, r

efl u

x, b

leed

ing,

her

nias

, gas

tric-

pouc

h di

lata

tion

and

food

into

lera

nce.

57

TAB

LE B

-2

Com

pari

sons

bet

wee

n op

en a

nd la

paro

scop

ic v

erti

cal b

ande

d ga

stro

plas

ty

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I(K

G/M

2)

AOT

(MIN

)AL

OS

(DAY

S)

MEA

N

FOLL

OW

-U

P(M

ON

THS)

COM

PLIC

ATIO

NS

OU

TCO

MES

Dáv

ila-

Cer

vant

es

et a

l., 2

002

(RC

)

VB

G: 1

4 (c

o-m

orbi

ditie

s pr

esen

t in

8 ca

ses)

43(3

7–50

)10

5(6

5–15

0)4

(3–4

2*)

12

8 pa

tient

s ha

d co

mpl

icat

ions

:

6

wou

nd-r

elat

ed p

robl

ems

2 fi s

tula

s at t

he g

astri

c pa

rtitio

n re

quiri

ng

re-o

pera

tion

N

o de

aths

V

BG

LV

BG

Susp

ensi

on o

f an

alge

sics

(day

s)

3 2

EWL:

at 1

yea

r 55

%

47%

(3

0–88

) (2

2–97

)

N

o si

gnifi

cant

diff

eren

ce in

pai

n in

tens

ity

betw

een

patie

nts i

n th

e 2

grou

ps. H

owev

er,

patie

nts i

n th

e V

BG

gro

up re

quire

d hi

gher

ex

tra d

oses

of n

arco

tics d

urin

g th

e fi r

st p

ost-

oper

ativ

e da

y.

Spiro

met

ric p

aram

eter

s wer

e si

mila

r for

the

2 gr

oups

dur

ing

the fi r

st 3

pos

t-ope

rativ

e da

ys. I

nspi

rato

ry a

nd e

xpira

tory

forc

e va

lues

wer

e ne

verth

eles

s hig

her i

n th

e LV

BG

pat

ient

s 3 d

ays p

ost-o

pera

tivel

y (r

espe

ctiv

ely

60 a

nd 6

5 cm

H2O

for t

he L

VB

G

patie

nts v

s 50

and

54.5

cm

H2O

for t

he G

VC

pa

tient

s).

Pa

tient

s in

the

LVB

G g

roup

s wer

e fa

ster

to

retu

rn to

thei

r nor

mal

act

iviti

es.

G

reat

er sa

tisfa

ctio

n ex

pres

sed

by th

e LV

BG

pa

tient

s.

LVB

G: 1

6(c

o-m

orbi

ditie

s pr

esen

t in

9 ca

ses)

45(3

8–50

)13

0(9

0–24

0)4

(3–9

7*)

4 pa

tient

s ha

d co

mpl

icat

ions

:

2

min

or c

ompl

icat

ions

: pu

lmon

ary

atel

ecta

sis (

1)

and

wou

nd in

fect

ion

(1)

2 fi s

tula

s at t

he g

astri

c pa

rtitio

n re

quiri

ng

re-o

pera

tion

N

o de

aths

* Ex

trem

e va

lues

are

due

to th

e le

ngth

of h

ospi

tal s

tay

of p

atie

nts w

ith c

ompl

icat

ions

such

as fi

stu

las (

one

in e

ach

grou

p).

58

APPE

ND

IX C

O

UTC

OM

ES O

F ST

UD

IES

ON

GAS

TRIC

BYP

ASS

TAB

LE C

-1

Ope

n ga

stri

c by

pass

AUTH

OR

SN

UM

BER

O

F PA

TIEN

TS

BM

I OR

IN

ITIA

L W

EIG

HT

AOT

(MIN

)AL

OS

(DAY

S)

MEA

N

FOLL

OW

-UP

(MO

NTH

S)EA

RLY

CO

MPL

ICAT

ION

SM

OR

TALI

TY

RAT

ELA

TE C

OM

PLIC

ATIO

NS

OU

TCO

MES

Mac

Lean

et

al.,

20

00

(R)

RYG

B: 2

43

- O

bese

(O):

13- P

atie

nts w

ith

mor

bid

obes

ity

(MO

): 13

4- S

uper

-obe

se

(SO

): 96

49 k

g/m

2

Unspecifi ed

Unspecifi ed

66 ±

18

Uns

pecifi e

d0.

41%

Her

nias

: 16%

EWL:

≥ 5

0%-

93%

of p

atie

nts w

ith o

besi

ty

or m

orbi

d ob

esity

- 57

% o

f sup

er-o

bese

Fina

l BM

I:O

and

MO

: 29

± 4

kg/m

2

SO: 3

5 ±

7 kg

/m2

Fobi

et

al.,

1998

(R)

RYG

B: 9

4446

kg/

m2

Unspecifi ed

4 24

2.7%

0.4%

Pulm

onar

y em

bolis

m: 0

.6%

Leak

: 3.1

%H

erni

a: 4

.7%

EWL:

80%

Wes

tling

et a

l.,

2002

(R)

RYG

B: 4

4 pa

tient

s pr

evio

usly

trea

ted

with

SAG

B: 2

6V

BG

: 13

GB

P: 5

35 k

g/m

2

(21–

49)

155

(88–

240)

6 (4

–15)

24In

tra-o

pera

tive

hem

orrh

age:

1In

fect

ed h

emat

oma:

1M

inor

surg

ery:

5

1 de

ath

(lung

can

cer)

11%

- Se

ptic

emia

: 1-

Stric

ture

in th

e ga

stro

-en

tero

anas

to m

osis

: 2-

Bow

el o

bstru

ctio

n: 4

- D

eep

veno

us

thro

mbo

sis:

2-

Re-

oper

atio

ns: 8

(1 e

arly

and

7 la

te)

At 2

yea

rs:

BM

I: 28

kg/

m2 (1

8–42

)Im

prov

ed q

ualit

y of

life

in

98%

of p

atie

nts (

wei

ght

redu

ctio

n an

d ab

senc

e of

the

com

plic

atio

ns a

ssoc

iate

d w

ith th

eir p

revi

ous g

astri

c re

stric

tions

in 7

0% o

f pa

tient

s)C

apel

la

and

Cap

ella

,20

02(R

)

RYG

B-V

BG

: 652

11

2 pa

tient

s (7

2 co

ntac

ted)

fr

om a

n or

igin

al

serie

s of 6

52

140

kg

(94–

288)

50 k

g/m

2 (3

8–86

)

42%

of

patie

nts

wer

e cl

assifi e

d as

su

per-o

bese

: B

MI o

f 60

kg/

m2

(48–

86)

Unspecifi ed

Unspecifi ed

60Ea

rly c

ompl

icat

ions

re

quiri

ng re

-ope

ratio

n:-

Bow

el o

bstru

ctio

n: 3

- O

bstru

ctio

n of

exc

lude

d lim

b: 1

- G

astro

-inte

stin

al b

leed

ing:

1

Early

com

plic

atio

ns le

adin

g to

an

ALO

S >

3 da

ys:

- St

rictu

re g

astro

jeju

nost

omy:

3-

Acu

te g

out a

ttack

: 2-

Wou

nd in

fect

ion:

4-

Pulm

onar

y em

bolis

m: 1

- R

espi

rato

ry: 2

- R

enal

: 1-

Dia

rrhe

a an

d C

lost

ridia

di

ffi ci

le in

fect

ions

: 20

2 de

aths

Late

com

plic

atio

ns

requ

iring

re

-ope

ratio

n:-

Esop

hage

al st

rictu

re: 3

- In

cisi

onal

her

nias

: 26

Late

com

plic

atio

ns n

ot

requ

iring

surg

ery:

- C

hron

ic o

r rec

urre

nt

anas

tom

otic

ulc

er: 3

- G

astro

-inte

stin

al

blee

ding

: 6-

Stom

al st

rictu

re: 6

At 5

yea

rs:

Wei

ght l

oss:

58

kg (1

4–14

3)B

MI:

29 k

g/m

2 (2

0–43

)EW

L: 7

7% (3

2–10

8)

(EW

L >

50%

in 9

3% o

f pa

tient

s)

Supe

r-obe

se g

roup

(3

0 pa

tient

s):

BM

I: 32

± 6

kg/

m2

EWL:

74

± 15

%

(97%

of p

atie

nts l

ost m

ore

than

50%

of t

heir

exce

ss

wei

ght)

59

TAB

LE C

-2

Lap

aros

copi

c ga

stri

c by

pass

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

INIT

IAL

BM

I (K

G/M

2)

AOT

(MIN

)AL

OS

(DAY

S)CO

MPL

ICAT

ION

S

Dre

sel

et a

l.,20

04(P

)

120

patie

nts u

nder

wen

t LRY

GB

be

twee

n Ja

nuar

y 20

02 a

nd A

ugus

t 200

2

60 o

bese

pat

ient

s (56

wom

en +

4 m

en)

with

BM

Is le

ss th

an 5

0 (O

gro

up)

rece

ived

a 1

00-c

m R

oux

limb

60 su

per-o

bese

pat

ient

s (50

wom

en

+ 10

men

) with

BM

Is g

reat

er th

an 5

0 (S

O g

roup

) rec

eive

d a

150-

cm R

oux

limb

Trea

tmen

t was

the

sam

e in

bot

h gr

oups

, ex

cept

for t

he le

ngth

of t

he R

oux

limbs

.

Age

(NS)

: -

O g

roup

: 41

(19–

64)

- SO

gro

up: 4

0 (1

9–60

)

Co-

mor

bidi

ties (

NS)

:-

O g

roup

: 5-

SO g

roup

: 6

O: 4

4.6

(39–

49)

SO: 5

8.4

(50–

100)

Non

-sig

nifi c

ant

diffe

renc

e

O: 1

28(7

5–22

5)SO

: 144

(75–

240)

O: 2

SO: 2

Late

ana

stom

otic

stric

ture

s, tre

ated

with

end

osco

pic

dila

tion

Re-

oper

atio

ns

Ana

stom

otic

ble

edin

g

Con

vers

ions

Dea

ths

Oth

er c

ompl

icat

ions

Ear

ly c

ompl

icat

ions

(< 7

day

s)- P

neum

onia

- Pul

mon

ary

edem

a - W

ound

infe

ctio

n- B

owel

obs

truct

ion

Late

com

plic

atio

ns- P

ulm

onar

y em

bolis

m- G

astro

gast

ric fi

stul

a- T

roca

r her

nia

O g

roup

3 0 3 0 0 1 – – – – – –

SO g

roup

4 2(1

her

nia

and

1 ga

stric

fi st

ula)

2 0 0 – 1 1 1 1 1 1

60

TAB

LE C

-2

Lap

aros

copi

c ga

stri

c by

pass

(con

’d)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I O

R

INIT

IAL

WEI

GH

T

FOLL

OW

-UP

(MO

NTH

S)AO

T(M

IN)

ALO

S(D

AYS)

COM

PLIC

ATIO

NS

OU

TCO

MES

Gag

ner

et a

l.,

1999

(R)

5255

kg/

m2

3627

74

Ear

ly c

ompl

icat

ions

: 15.

0%La

te c

ompl

icat

ions

: 3.8

%D

eath

s: 0

BM

I: 34

kg/

m2 at

18

mon

ths

Hig

a et

al.,

2000

(R)

400

46 k

g/m

222

Uns

pecifi e

d1.

6

Ear

ly c

ompl

icat

ions

: 15.

0%La

te c

ompl

icat

ions

: 15.

0%R

e-op

erat

ions

: 3%

Dea

ths:

0

EWL:

69%

at 1

2 m

onth

s

Scha

uer

et a

l.,

2000

(P)

275

48 k

g/m

230

247

2.6

Ear

ly c

ompl

icat

ions

: 3.3

%La

te c

ompl

icat

ions

: 27.

0%R

e-op

erat

ions

: 1%

D

eath

s: 1

EWL:

77%

at 3

0 m

onth

s

Witt

grov

e an

d C

lark

,20

00(R

)

500

Uns

pecifi e

d60

120

2.6

Ear

ly c

ompl

icat

ions

: 10.

4%La

te c

ompl

icat

ions

: 2.2

%D

eath

s: 0

EWL:

73%

at 5

4 m

onth

s

Frez

zaet

al.,

20

02(R

)

238

(LRY

GB

)

(152

vol

unte

ers w

ith

gast

ro-e

soph

agea

l refl

ux

dise

ase,

of w

hom

one

third

ha

d al

read

y un

derg

one

surg

ery)

289.

1 lb

s(2

21–4

57)

48 k

g/m

2

(39–

67.9

)

12(6

–36)

Uns

pecifi e

dU

nspe

cifi e

dC

onve

rsio

ns: 0

.7%

EWL:

68.

8% a

t 12

mon

ths

Res

olut

ion

of sy

mpt

oms i

n 80

% o

f ca

ses

Impr

oved

qua

lity

of li

fe in

90%

of

patie

nts

DeM

aria

et a

l.,

2002

b(R

)

281

(LG

BP)

pat

ient

s su

rgic

ally

trea

ted

betw

een

Mar

ch 1

998

and

Oct

ober

200

1

(25

with

LG

BP

+ ha

nd-

assi

sted

pro

cedu

re)

291

± 46

.6 lb

s(1

71–4

46)

48.1

± 6

.5 k

g/m

2

(40.

3–71

)

12(6

9 pa

tient

s)U

nspe

cifi e

d4

± 9

(273

pat

ient

s)

15.8

± 2

5(8

pat

ient

s)

Com

plic

atio

ns:

Stom

al st

enos

is: 6

.6%

Gas

trodu

oden

al u

lcer

s: 5

.1%

Ana

stom

otic

leak

: 5.1

%O

ther

: 7.1

% (h

erni

as;

infe

ctio

ns; p

ulm

onar

y em

bolis

ms)

Con

vers

ions

/re-

oper

atio

ns:

2.8%

Dea

ths:

0

At 1

yea

r:EW

L: 7

0 ±

15%

; BM

I: 30

.5 ±

5.1

kg/

m2

Wei

ght:

180

± 30

lbs

Dia

bete

s: 9

3% o

f pat

ient

s no

long

er

need

ed m

edic

atio

n.G

astro

-eso

phag

eal r

efl u

x di

seas

e w

as

reso

lved

in 9

5% o

f cas

es.

Hyp

erte

nsio

n: re

turn

ed to

nor

mal

in 5

2%

of c

ases

.B

enefi

cia

l im

pact

on

obes

ity-r

elat

ed

orth

oped

ic p

robl

ems.

61

TAB

LE C

-2

Lap

aros

copi

c ga

stri

c by

pass

(con

t’d)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I(K

G/M

2)

AOT

(MIN

)AL

OS

(DAY

S)CO

MPL

ICAT

ION

SO

UTC

OM

ES

Stoo

pen-

Mar

gain

et a

l.,

2004

(P)

100

cons

ecut

ive

patie

nts

who

und

erw

ent L

RYG

B

betw

een

Febr

uary

200

0 an

d Se

ptem

ber 2

002

63 fe

mal

es a

nd 3

7 m

ales

Mea

n ag

e: 3

1 ±

5 ye

ars

Pre-

oper

ativ

e co

-mor

bidi

ties:

Hyp

erte

nsio

n 46

Dia

bete

s 24

Slee

p ap

nea

24H

yper

lipid

emia

22

Ost

eoar

thro

path

y 13

Veno

us in

suffi

cien

cy

12H

yper

uric

emia

9

Pneu

mop

athy

9

Dep

ress

ion

5H

ypot

hyro

idis

m

4G

astro

-eso

phag

eal

refl u

x di

seas

e 2

Pulm

onar

y hy

perte

nsio

n 2

Isch

emic

car

diop

athy

1

50 ±

9

33 su

per-o

bese

pa

tient

s with

B

MIs

> 5

0

228

± 42

6Le

ak: 1

as a

resu

lt of

st

aple

-line

dis

rupt

ion

Ana

stom

otic

sten

osis

: 4B

owel

obs

truct

ion:

4H

emat

oma:

1W

ound

infe

ctio

n: 4

at t

he

troca

r site

R

habd

omyo

lysi

s: 2

2 Th

rom

bo-e

mbo

lism

: 1

Con

vers

ions

: 2

(1 c

ause

d by

the

pres

ence

of n

umer

ous

adhe

sion

s and

1 b

ecau

se

of a

n ex

tens

ivel

y en

larg

ed le

ft liv

er lo

be)

Dea

ths:

2 p

ost-o

pera

tive

deat

hs1

thro

mbo

-em

bolis

m1

acut

e re

spira

tory

di

stre

ss

BM

I (kg

/m2 )

6 m

onth

s: 4

7 ±

2 (n

= 8

2)12

mon

ths:

62

± 4

(n =

70)

18 m

onth

s: 6

6 ±

5 (n

= 6

3)24

mon

ths:

67

± 8

(n =

35)

Impa

ct o

n co

-mor

bidi

ties:

B

efor

e A

fter

su

rger

y (2

0 ±

11 m

os)

BM

I (kg

/m2 )

50 ±

9

36.4

± 6

.4

Dia

bete

s- T

reat

ed w

ith

hypo

glyc

emic

dru

gs

20

11- T

reat

ed w

ith d

iet

4

3

Hyp

erte

nsio

n- 1

dru

g 42

23

- 2 d

rugs

4

1

Hyp

erlip

idem

ia- H

yper

trigl

ycer

idem

ia

8

4- H

yper

chol

este

role

mia

14

12

Bro

dy,

2004

(R)

195

patie

nts t

reat

ed w

ith L

RYG

B(u

ntil

Dec

embe

r 31,

200

3)

Follo

w-u

p of

18

mon

ths

A to

tal o

f 36

of th

ese

patie

nts

dire

ctly

und

erw

ent o

pen

surg

ery

beca

use

of v

entil

ator

y pr

oble

ms

upon

ane

sthe

sia

or a

his

tory

of

prio

r sur

gerie

s.

51.5

(mea

n)LR

YG

B:

2.96

RYG

B:

5.11

Con

vers

ions

:4.

08

Leak

age:

2(1

ana

stom

otic

leak

tre

ated

by

drai

nage

, and

1

gast

ric-p

ouch

leak

)W

ound

infe

ctio

n: 9

(sur

gica

lly tr

eate

d)Ev

isce

ratio

n: 1

Sple

nect

omy:

3

(1 d

ue to

a ru

ptur

e an

d 2

to re

tract

ion

inju

ries)

Bow

el o

bstru

ctio

n: 5

re

quiri

ng su

rger

yC

onve

rsio

ns: 3

6 (1

8.5%

)R

e-op

erat

ions

: 17

At 1

8 m

onth

s, th

e pa

tient

s had

lost

35%

of t

heir

initi

al

wei

ght.

The

mea

n B

MI f

ell f

rom

51.

5 to

32.

0 kg

/m2 .

62

TAB

LE C

-3

Com

pari

sons

bet

wee

n op

en a

nd la

paro

scop

ic g

astr

ic b

ypas

s

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I OR

IN

ITIA

L W

EIG

HT

AOT

(MIN

)AL

OS

(DAY

S)FO

LLO

W-U

P(M

ON

THS)

COM

PLIC

ATIO

NS

OU

TCO

MES

Ngu

yen

et a

l.,

2001

(RC

)

RYG

B: 7

648

.4 ±

5.4

kg/

m2

195

± 41

49.

6–6.

3(1

–23)

Ear

ly c

ompl

icat

ions

: 9.2

% (7

cas

es)

- Ana

stom

otic

leak

: 1- B

owel

obs

truct

ion:

1- R

espi

rato

ry fa

ilure

: 1- P

ulm

onar

y em

bolis

m: 1

- Inf

ectio

n: 2

- Ret

aine

d la

paro

tom

y sp

onge

: 1

Late

com

plic

atio

ns: 1

5.8%

(12

case

s)- A

nast

omot

ic st

rictu

re: 2

- Ven

tral h

erni

a: 6

- Ane

mia

: 2- O

ther

gas

tro-in

test

inal

co

mpl

icat

ion:

2

Re-

oper

atio

ns: 6

.6%

of c

ases

No

deat

hs

EW

L

RY

GB

LR

YG

B

p th

resh

old

3 m

onth

s 32

± 1

0%

37 ±

10%

0.

016

mon

ths

45 ±

12%

54

± 1

4%

0.01

1 ye

ar

62 ±

14%

68

± 1

5%

0.07

LRY

GB

: 79

47.6

± 4

.7 k

g/m

222

5 ±

403

9.6–

6.5

(1–2

3)E

arly

com

plic

atio

ns: 7

.6%

(6 c

ases

)- A

nast

omot

ic le

ak: 1

- Bow

el o

bstru

ctio

n: 3

- Per

fora

tion:

1- G

astro

-inte

stin

al b

leed

ing:

1

Late

com

plic

atio

ns: 1

8.9%

(15

case

s)- A

nast

omot

ic st

rictu

re: 9

- Cho

lelit

hias

is: 3

- Pro

tein

-cal

orie

mal

nutri

tion:

1- O

ther

gas

tro-in

test

inal

co

mpl

icat

ion:

2

Con

vers

ions

: 2.5

% (2

pat

ient

s)

Re-

oper

atio

ns: 7

.6%

of t

he c

ases

No

deat

hs

63

TAB

LE C

-3

Com

pari

sons

bet

wee

n op

en a

nd la

paro

scop

ic g

astr

ic b

ypas

s (co

nt’d

)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I OR

IN

ITIA

L W

EIG

HT

AOT

(MIN

)AL

OS

(DAY

S)

MEA

N

FOLL

OW

-UP

(MO

NTH

S)

COM

PLIC

ATIO

NS

OU

TCO

MES

Wes

tling

an

d G

usta

vsso

n,20

01(R

C)

LRY

GB

: 30

Cho

lecy

stec

tom

y: 3

Join

t and

bac

k pa

in: 1

0H

yper

tens

ion:

7A

sthm

a: 5

Rhe

umat

oid

arth

ritis

: 0D

iabe

tes:

0

41 k

g/m

2Ex

clud

ing

conv

ersi

ons*

:23

5 (1

65–3

90)

(n =

23)

Incl

udin

g co

nver

sion

s:24

5 (1

35–3

90)

(n =

30)

With

out

conv

ersi

on*:

4 ±

0.8

(n =

222

)

With

co

nver

sion

:4.

5 ±

1.2

(n =

292

)

12C

onve

rsio

n to

ope

n su

rger

y: 2

3%

(7 c

ases

)

Intra

-ope

rativ

e bl

eedi

ng:

- 20

0 m

l (50

–400

): n

= 23

(exc

ludi

ng

conv

ersi

ons)

- 25

0 m

l (50

–150

0): n

= 3

0 (in

clud

ing

conv

ersi

ons)

Early

and

late

com

plic

atio

ns (i

nclu

ding

co

nver

sion

s):

- R

e-op

erat

ions

for b

owel

ob

stru

ctio

n: 6

- Pu

lmon

ary

embo

lism

: 1-

Gas

tric

ulce

r: 1

- G

astro

jeju

nal s

trict

ure:

1-

Oth

er re

-adm

issi

ons:

2 fo

r epi

gast

ric

pain

and

1 fo

r pne

umon

ia

BM

I at

1 y

ear:

LRY

GB

: 27

± 4

kg/m

2 (dec

reas

e in

BM

I: 14

± 3

)

RYG

B: 3

0.6

± 4

kg/m

2 (dec

reas

e in

BM

I: 13

± 3

)N

on-s

ignifi c

ant d

iffer

ence

AO

T: 2

tim

es lo

nger

than

in th

e LR

YG

B g

roup

Pain

: lap

aros

copy

pat

ient

s (ex

clud

ing

conv

ersi

ons)

seem

ed to

hav

e le

ss p

ain

than

the

open

-sur

gery

pat

ient

s (ev

alua

ted

acco

rdin

g to

m

orph

ine

dose

s adm

inis

tere

d).

Mor

phin

e do

se:

- LR

YG

B g

roup

: 69

± 46

.4 m

g fo

r the

22

2 pa

tient

s who

did

not

und

ergo

con

vers

ion

(98

± 71

.5 fo

r the

gro

up c

ombi

ned

[n =

292

], in

clud

ing

conv

ersi

ons)

- RY

GB

gro

up (n

= 2

1): 1

40 ±

90

mg

Sign

ifi ca

nt d

iffer

ence

(p <

0.0

05)

ALO

S: sh

orte

r with

LRY

GB

The

diffe

renc

e is

sign

ifi ca

nt, a

nd e

spec

ially

pr

onou

nced

in th

e gr

oup

incl

udin

g co

nver

sion

s (p

< 0

.025

).

Rec

over

y pe

riod:

shor

ter w

ith L

RYG

B

(p <

0.0

25)

Ther

e is

no

corr

elat

ion

betw

een

the

pre-

oper

ativ

e B

MI,

the

mor

phin

e do

se a

dmin

iste

red

and

the A

LOS.

Deg

ree

of p

atie

nt sa

tisfa

ctio

n: It

was

hig

h an

d id

entic

al fo

r pat

ient

s in

both

gro

ups (

92%

of t

he

patie

nts r

epor

ted

that

they

wer

e ve

ry sa

tisfi e

d an

d 8%

satisfi e

d; 5

% o

f the

pat

ient

s que

stio

ned

repo

rted

expe

rienc

ing

sym

ptom

s ass

ocia

ted

with

the

dum

ping

synd

rom

e bu

t wer

e no

t di

stur

bed

by th

em.

RYG

B: 2

1

Cho

lecy

stec

tom

y: 6

Join

t and

bac

k pa

in: 8

Hyp

erte

nsio

n: 0

Ast

hma:

5R

heum

atoi

d ar

thrit

is: 1

Dia

bete

s: 1

43.9

kg/

m2

100

(70–

150)

6 ±

3.8

Intra

-ope

rativ

e bl

eedi

ng:

- 30

0 m

l (20

0–50

0)

Early

and

late

com

plic

atio

ns:

- R

e-op

erat

ion

for l

eaks

: 1-

Gas

tric

ulce

r: 2

- M

inor

wou

nd in

fect

ion:

3-

Her

nia:

1-

Oth

er re

-adm

issi

ons:

1 fo

r un

expl

aine

d fe

ver

* B

leed

ing

was

the

maj

or c

ause

of c

onve

rsio

n (la

paro

scop

y to

ope

n su

rger

y) fo

r 4 p

atie

nts.

Ble

edin

g ca

me

from

a tr

ocar

site

, the

shor

t gas

tric

vess

els,

a st

aple

line

in th

e R

oux

limb

and

an

intra

mur

al g

astri

c ar

tery

. Oth

er re

ason

s for

con

vers

ions

wer

e la

ck o

f exp

osur

e, d

iffi c

ultie

s in

defi n

ing

the

mes

ocol

ic tu

nnel

, unf

avou

rabl

e tro

car p

ositi

onin

g an

d th

e ac

cide

ntal

dis

cove

ry o

f a

hiat

al h

erni

a. O

ne la

paro

scop

ic p

roce

dure

was

con

verte

d to

ope

n su

rger

y w

hen

it w

as d

isco

vere

d th

at th

e je

junu

m h

ad b

een

trans

ecte

d m

ore

than

one

met

re fr

om th

e lig

amen

t of T

reitz

.

64

TAB

LE C

-3

Com

pari

sons

bet

wee

n op

en a

nd la

paro

scop

ic g

astr

ic b

ypas

s (c

ont’d

)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I OR

IN

ITIA

L W

EIG

HT

AOT

(MIN

)AL

OS

(DAY

S)

MEA

N

FOLL

OW

-U

P (M

ON

THS)

COM

PLIC

ATIO

NS

OU

TCO

MES

Cou

rcou

las

et a

l.,

2003

a(P

CC

)

80 p

airs

mat

ched

by

age

, sex

, pr

e-op

erat

ive

BM

I and

num

ber

of c

o-m

orbi

ditie

sG

BP:

80

LGB

P: 8

0

GB

P: 4

6 kg

/m2

LGB

P: 4

4 kg

/m2

(mea

n)

Unspecifi ed

3.6

12

GB

LG

BB

leed

ing

1 1

Pulm

onar

y em

bolis

m

1 (d

eath

) 1

Infe

ctio

n 9

3Su

ture

dis

rupt

ion

6 –

Min

or b

owel

obs

truct

ion

– 6

Pneu

mon

ia

– 1

Ana

stom

otic

stric

ture

–

5Ile

us

– 1

Leak

–

2

St

atis

tical

G

B

LGB

te

stM

ean

EWL

6 m

onth

s:

45.0

%

52.6

%

p <

0.05

9 m

onth

s:

51.4

%

68.4

%

p <

0.05

1 ye

ar:

64.9

%

69.2

%

NS

BM

I(m

ean

in

kg/m

2 )1

year

: 31

.3

29.6

–

Ret

urn

to

norm

al

activ

ities

(wee

ks):

9.

8 ±

16

7.3

± 16

–

Qua

lity

of li

fe (S

F-36

): no

sign

ifi ca

nt d

iffer

ence

65

TAB

LE C

-3

Com

pari

sons

bet

wee

n op

en a

nd la

paro

scop

ic g

astr

ic b

ypas

s (c

ont’d

)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I OR

IN

ITIA

L W

EIG

HT

AOT

(MIN

)AL

OS

(DAY

S)

MEA

N

FOLL

OW

-U

P (M

ON

THS)

COM

PLIC

ATIO

NS

OU

TCO

MES

Lujá

n et

al.,

20

04(R

C)

LGB

P: 5

3(1

0 m

ales

and

43

fem

ales

)A

ge: 3

7 ye

ars

(18–

64)

GB

P: 5

1(1

3 m

ales

and

38

fem

ales

)A

ge: 3

8 ye

ars

(20–

63)

130.

7 kg

(92–

208)

48.5

3 kg

/m2

(36–

78)

137.

57 k

g(9

6–21

4)52

.20

kg/m

2

(37–

80)

186.

4(1

25–2

90)

201.

712

9–31

0)(p

< 0

.05)

5.2

(1–1

3)

7.9

(2–2

8)(p

< 0

.05)

23

LGB

G

BE

arly

(<

30

days

) 22

.6%

29

.4%

- Int

estin

al su

bocc

lusi

on

3 –

- Asy

mpt

omat

ic le

ak

2 –

- Int

ra-a

bdom

inal

ble

edin

g 2

–

- Upp

er g

astro

-inte

stin

al h

emor

rhag

e 2

3- I

ntra

-abd

omin

al h

emor

rhag

e 1

–- T

hrom

boph

lebi

tis

1 –

- Ste

nosi

s of t

he g

astro

-ent

ero-

anas

tom

osis

1

–- S

ubph

reni

c ab

sces

s –

4- W

ound

infe

ctio

n –

4- P

ulm

onar

y in

fect

ion

– 3

- Evi

scer

atio

n (d

eath

) –

1

Late

(>

10

days

) 11

%

24%

- Par

tial b

owel

obs

truct

ion

3*

1†

- Pan

crea

titis

(cho

lecy

stec

tom

y)

2 –

- Sud

den

deat

h 1

–- A

bdom

inal

-wal

l her

nia

– 10

- Sub

phre

nic

absc

ess

1 –

Afte

r a (m

ean)

follo

w-u

p of

23

mon

ths,

the

auth

ors d

id n

ot

note

a si

gnifi

cant

diff

eren

ce in

the

chan

ges i

n B

MI b

etw

een

the

two

grou

ps o

f pat

ient

s.

* O

ne p

atie

nt re

ceiv

ed m

edic

al tr

eatm

ent a

nd th

e tw

o ot

hers

surg

ical

trea

tmen

t (1

deat

h).

† A

seco

nd p

roce

dure

was

nec

essa

ry.

66

APPE

ND

IX D

O

UTC

OM

ES O

F ST

UD

IES

ON

BIL

IOPA

NCR

EATI

C D

IVER

SIO

N

TAB

LE D

-1

Ope

n bi

liopa

ncre

atic

div

ersi

on

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I O

R IN

ITIA

L W

EIG

HT

AOT

(MIN

)AL

OS

(DAY

S)FO

LLO

W-U

PCO

MPL

ICAT

ION

SO

UTC

OM

ES

Hes

s and

H

ess,

1998

(R)

BPD

-DS:

440

50 k

g/m

2

199–158

Unspecifi ed

9–108 months

Peri-

oper

ativ

e m

edic

al c

ompl

icat

ions

: 8- D

eep

vein

thro

mbo

phle

bitis

: 0.7

5% (3

) - P

ulm

onar

y em

bolis

m: 0

.5%

(2)

- Pne

umon

ia: 0

.5%

(2)

- Acu

te re

spira

tory

dis

tress

synd

rom

e: 0

.25%

(1)

Peri-

oper

ativ

e su

rgic

al c

ompl

icat

ions

: 23

- Gas

tric

leak

and

fi st

ula

(per

fora

tion

or

stap

le-li

ne d

isru

ptio

n): 2

% (9

)- G

astro

duod

enal

leak

: 1.5

% (6

)- S

plen

ecto

my

(inci

dent

al):

0.9%

(4)

- Dis

tal R

oux-

en-Y

leak

: 0.2

5% (1

)- P

ost-o

pera

tive

blee

ding

requ

iring

su

rger

y: 0

.5%

(2)

- Abs

cess

(not

rela

ted

to le

aks)

: 0.2

5% (1

)La

te c

ompl

icat

ions

: 11

- Duo

dena

l sto

mal

obs

truct

ion:

0.7

5% (3

)- S

mal

l bow

el o

bstru

ctio

n: 2

% (8

)

Post

-ope

rativ

e at

elec

tasi

s in

20%

of p

atie

nts

17 su

rgic

al re

visi

ons

Dea

ths:

1.2

% (2

ear

ly a

nd 3

late

)

EWL:

361

pat

ient

s (ba

sed

on la

st

wei

ght m

easu

rem

ent)

- Exc

elle

nt (a

t lea

st 8

0%):

79.8

%- G

ood

(at l

east

60%

): 13

.0%

- Fai

r (at

leas

t 40%

): 6.

9%- P

oor (

at le

ast 2

0%):

0.3%

- Fai

lure

(< 2

%):

0.0%

Year

NSa

tisfa

ctor

y(a

t lea

st 4

0%)

Goo

d–ex

celle

nt(a

t lea

st 6

0%)

1

345

344

320

2

264

263

240

3

187

186

167

4

132

132

117

5

92

92

80 6

51

51

45

7

29

29

25 8

11

11

9

Scop

inar

o et

al.,

20

00(R

)

BPD

-DG

: 231

6 (d

iffer

ent v

aria

nts)

47 k

g/m

2

(29–

87)

128

kg

(73–

236)

Unspecifi ed

Unspecifi ed

Maximum of 15 years

Ope

rativ

e m

orta

lity

rate

: < 0

.5%

Late

com

plic

atio

ns: >

5%

EWL:

6 ye

ars:

75

± 15

% (n

= 1

054)

10 y

ears

: 76

± 15

% (n

= 3

81)

Biro

n et

al.,

2004

(R)

BPD

-DG

: 997

ou

t of 1

271

cons

ecut

ive

patie

nts

(81.

4% b

y sl

eeve

ga

stre

ctom

y st

artin

g in

199

0)(F

ebru

ary

1984

to

Dec

embe

r 200

2)

48.4

±

9.4

kg/m

2 13

0 ±

30 k

g Unspecifi ed

Unspecifi ed

7.9 ± 4.2 years

Ope

rativ

e m

orta

lity

rate

: 0%

Late

com

plic

atio

ns: >

5%

BM

I (m

ean)

:Pr

e-op

erat

ive:

48.

4 ±

9.4

kg/m

2

Post

-ope

rativ

e: 3

1.3

± 6.

5 kg

/m2

The

oper

atio

n w

as c

onsi

dere

d a

failu

re

for p

atie

nts w

ho h

ad B

MIs

≥ 3

5 af

ter

the

oper

atio

n (1

0%: B

MI ≥

40;

and

26

%: 3

5 ≤

BM

I < 4

0).

67

TAB

LE D

-1

Ope

n bi

liopa

ncre

atic

div

ersi

on (c

ont’d

)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I OR

IN

ITIA

L W

EIG

HT

FOLL

OW

-U

P(M

ON

THS)

OU

TCO

MES

EWL

(%)

IMPA

CT O

N C

O-M

OR

BID

ITIE

S AN

D C

OM

PLIC

ATIO

NS

Mar

inar

i et

al.,

2004

(R)

- 858

of 1

800

patie

nts

who

und

erw

ent B

PD

betw

een

June

198

4 an

d D

ecem

ber 1

998

com

plet

ed th

e en

tire

ques

tionn

aire

- 709

of 8

58 p

atie

nts

had

co-m

orbi

ditie

s

- 615

fem

ales

- Age

: 38

± 11

yea

rs

- 596

pat

ient

s ope

rate

d be

twee

n Ju

ne 1

984

and

Sept

embe

r 199

2: B

PD

with

ad

hoc

stom

ach

(ada

pted

to p

atie

nt

char

acte

ristic

s), w

ith a

50

-cm

com

mon

lim

b an

d a

200-

cm st

anda

rd

alim

enta

ry li

mb

(BPD

-AH

S)

- 262

pat

ient

s ope

rate

d af

ter S

epte

mbe

r 199

2:ad

hoc

alim

enta

ry li

mb

(BPD

-AH

S-A

HA

L)

BM

I: 47

± 7

kg/

m2

Wei

ght:

128

± 26

kg

Exce

ss w

eigh

t: 11

7 ±

38%

24–1

802

year

s: 6

7 ±

18 (n

= 8

00)

4 ye

ars:

67

± 18

(n =

738

)

6 ye

ars:

68

± 18

(n =

659

)

8 ye

ars:

69

± 18

(n =

532

)

10 y

ears

: 68

± 18

(n =

334

)

12 y

ears

: 66

± 18

(n =

131

)

14 y

ears

: 69

± 15

(n =

60)

BPD

-AH

S: 7

0.5

± 23

BPD

-AH

S-A

HA

L:

64.7

± 1

7 (N

S)

Co-

mor

bidi

ties

Dis

appe

ared

Im

prov

ed

Unc

hang

edH

yper

tens

ion

(52%

) 87

9

18D

yslip

idem

ia (4

6%)

100

– –

Type

2 d

iabe

tes (

14%

) 10

0 –

–O

besi

ty-h

ypov

entil

atio

nsy

ndro

me

(8%

) 10

0 –

–Sl

eep

apne

a (4

%)

100

– –

BA

RO

S B

PD-A

HS

B

PD-A

HS-

AH

AL

Failu

re

28 (3

.3%

)Fa

ir 97

(11.

3%)

Goo

d 19

5 (2

2.7%

)Ve

ry g

ood

341

(39.

7%)

83%

92

%Ex

celle

nt

197

(23%

)

Com

plic

atio

ns:

- Duo

dena

l lea

k: 1

- Com

plic

ated

pep

tic u

lcer

dis

ease

: 12

- Pul

mon

ary

embo

lism

: 1- P

rote

in d

efi c

ienc

y: 3

2 (r

ehos

pita

lized

)- H

erni

a re

quiri

ng h

ospi

tal s

tay

> 7

days

: 15

- Dep

ress

ion:

1- S

urge

ry re

visi

ons:

54

(6.3

%)

Re-

oper

atio

ns:

- BPD

-AH

S: 8

.6%

- BPD

-AH

S-A

HA

L: 1

.1%

68

TAB

LE D

-2

Lap

aros

copi

c bi

liopa

ncre

atic

div

ersi

on

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I OR

INIT

IAL

WEI

GH

T

FOLL

OW

-UP

(MO

NTH

S)AO

T(M

IN)

ALO

S(D

AYS)

MAJ

OR

CO

MPL

ICAT

ION

SO

UTC

OM

ES

Ren

et a

l.,20

00(P

)

40(B

PD-D

S)60

kg/

m2

(42–

85)

6(1

–12)

210

± 9

(110

–360

)4

17.5

%

Ble

edin

g: 4

Leak

: 1

Veno

us th

rom

bosi

s: 1

Subp

hren

ic a

bsce

ss: 1

Dea

ths:

1

EWL:

6 m

onth

s: 4

6 ±

2%

9 m

onth

s: 5

8 ±

3%

Paiv

a et

al.,

2001

(R)

10 (l

apar

osco

pic

Scop

inar

o B

PD)

40–5

5 kg

/m2

119.

3 kg

(100

–150

)

Uns

pecifi e

d4.

3 ho

urs

(3.5

–7)

5.2

(4–7

)C

onve

rsio

ns o

r re-

oper

atio

ns: 0

Dea

ths:

0W

eigh

t los

s: 1

.6–3

3 kg

/day

(m

ean

2.3

kg)

Bal

tasa

r et a

l.,20

02(R

)

16(B

PD-D

S)>

40 k

g/m

2U

nspe

cifi e

d19

5–27

05–

8(1

3 pa

tient

s)In

tra-o

pera

tive

com

plic

atio

ns: 3

Inte

rnal

ble

edin

g: 1

Parti

al st

enos

is o

f the

gas

tric

tube

: 1C

onve

rsio

ns o

r re-

oper

atio

ns: 0

Dea

ths:

0

No

BM

I or E

WL

outc

omes

Lapa

rosc

opic

BPD

with

du

oden

al sw

itch

is c

ompl

ex

but f

easi

ble.

Scop

inar

o et

al.,

2002

(R)

26(B

PD-D

G)

43 k

g/m

2 (m

ean)

6–12

U

nspe

cifi e

dU

nspe

cifi e

dU

nspe

cifi e

dTh

e au

thor

s con

clud

e th

at

outc

omes

are

sim

ilar t

o th

ose

achi

eved

with

lapa

rosc

opic

B

PD.

69

TAB

LE D

-3

Com

pari

sons

bet

wee

n op

en a

nd la

paro

scop

ic b

iliop

ancr

eati

c di

vers

ion

AUTH

OR

SN

UM

BER

O

F PA

TIEN

TS

BM

I OR

IN

ITIA

L W

EIG

HT

(MED

IAN

)

AOT

(MIN

)AL

OS

(DAY

S)

MEA

N

FOLL

OW

-UP

(MO

NTH

S)

COM

PLIC

ATIO

NS

OU

TCO

MES

Kim

et a

l.,20

03(R

NC

C)

BPD

-DS:

28

68.8

± 1

0.1

kg/m

2

196

± 29

.1 k

g

259

± 60

(180

–400

)5

± 47

10.1

(4–1

9)

BPD

LB

PDM

ajor

com

plic

atio

ns (N

S):

- Sub

phre

nic

absc

ess

0 1

- Ana

stom

otic

leak

0

1- R

espi

rato

ry fa

ilure

0

1- W

ound

dis

rupt

ion

1 –

- Wou

nd in

fect

ion

2 –

Min

or c

ompl

icat

ions

(NS)

:- L

ow-e

xtre

mity

ede

ma

0 1

- Wou

nd in

fect

ion

0 1

- Inc

isio

nal h

erni

a 0

1- U

rinar

y-tra

ct in

fect

ion

1 0

Cau

se o

f dea

th (N

S):

- Nec

rotiz

ing

panc

reat

itis

1 –

- Res

pira

tory

failu

re

– 1

- Ana

stom

otic

leak

–

1

EW

L (m

edia

n)

BPD

LB

PD3

mon

ths

32.2

± 1

5.6%

35

.6 ±

15.

6% (N

S)

(9.9

–60.

8)

(15.

4–77

.2)

6 m

onth

s 44

.3 ±

5.7

%

56.

9 ±

20.4

% (N

S)

(42.

6–56

.2)

(32.

6–91

.7)

9 m

onth

s 48

.7 ±

4.1

%

68.

1 ±

26.5

% (N

S)

(58.

5–68

.7)

(42.

0–10

2.6)

1 ye

ar

56.8

± 2

6.3%

76

.7 ±

19.

7% (N

S)

(32.

2–94

.8)

(68.

8–11

2.9)

BM

I (m

edia

n in

kg/

m2 )

1 ye

ar

48.2

± 6

.3

37.3

± 5

.6

(40.

7–54

) (3

1.2–

43.4

)

LBPD

-DS:

26

66 ±

7.5

kg/

m2

189

± 31

.7 k

g21

0 ±

68(1

45–4

03)

4 ±

4118

.5 (6

–13)

70

APPE

ND

IX E

O

UTC

OM

ES O

F ST

UD

IES

ON

GAS

TRIC

BAN

DIN

GTA

BLE

E-1

Swed

ish

adju

stab

le g

astr

ic b

andi

ng

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

INIT

IAL

WEI

GH

T AN

D B

MI

AOT

(MIN

)AL

OS

(DAY

S)CO

MPL

ICAT

ION

SO

UTC

OM

ES

Stef

fen

et a

l.,

2003

(P)

824

(ope

rate

d be

twee

n A

pril

1996

and

M

ay 1

997)

79: fi

rst-

gene

ratio

n LS

AG

B

754:

seco

nd-

gene

ratio

n LS

AG

B

(ope

rate

d be

twee

n M

ay 1

997

and

Febr

uary

200

1)

118

± 1

kg

(75–

224)

42.4

± 1

kg/

m2

(31–

69)

Exce

ss w

eigh

t: 90

± 1

%

(35–

368%

)

49 ±

17

3.7

Intra

-ope

rativ

e co

mpl

icat

ions

: 1.4

%

(12

case

s)

- 12

cas

es o

f tra

umat

ic in

tuba

tion.

All

intra

-ope

rativ

e co

mpl

icat

ions

occ

urre

d in

the fi r

st 1

00 p

atie

nts.

- Li

ver h

emat

oma

(5);

sple

nic

hem

orrh

age

(3):

hem

orrh

age

from

gas

tro-e

pipl

oic

vein

s (2)

; CO

2-em

bolis

m (1

); es

opha

geal

per

fora

tion

(1)

Post

-ope

rativ

e co

mpl

icat

ions

: M

inor

ear

ly c

ompl

icat

ions

: 3%

(25

case

s)-

13 p

atie

nts r

equi

red

antib

iotic

ther

apy

for p

ulm

onar

y at

elec

tasi

s or p

neum

onia

- 2

patie

nts r

equi

red

enem

as fo

r a p

rolo

nged

su

b-ile

us-

10 p

atie

nts h

ad m

inor

wou

nd p

robl

ems

Com

plic

atio

ns r

elat

ed to

the

band

: 6.3

%

(51

of 8

24 p

atie

nts i

n 5

year

s)-

Ban

d le

akag

e (1

4)*;

infe

ctio

n (2

)† ; sl

ippa

ge (2

2)‡ ;

eros

ion

(13)

§

Com

plic

atio

ns d

ue to

the

acce

ss p

ort o

r tu

be|| :

6.8%

(56

out o

f 824

pat

ient

s in

5 ye

ars)

- In

fect

ion

(8);

hem

atom

a (2

); di

scom

fort/

prom

inen

ce

(19)

; dis

loca

tion

(8);

tube

leak

(10)

; tub

e di

scon

nect

ing/

kink

ing

(9)

EW

L (%

) B

MI (

kg/m

2 )

1 ye

ar (n

= 8

21)

29.5

± 0

.5

35.8

± 0

.2

2 ye

ars (

n =

744)

41

.1 ±

0.7

33

.2 ±

0.1

3 ye

ars (

n =

593)

48

.7 ±

0.9

31

.5 ±

0.2

4 ye

ars (

n =

380)

54

.5 ±

1.2

30

.0 ±

0.3

5 ye

ars (

n =

184)

57

.1 ±

1.9

29

.2 ±

0.4

- W

eigh

t los

s was

con

side

red

insu

ffi ci

ent i

n 14

1 (1

7.1%

) pa

tient

s. A

n ad

juva

nt tr

eatm

ent w

ith li

pid-

abso

rptio

n in

hibi

tors

(orli

stat

) or s

ibut

ram

ine

was

adm

inis

tere

d to

86

of t

hese

pat

ient

s, w

ith a

succ

ess r

ate

of 6

6.3%

; 26

of

141

patie

nts (

2.1%

) req

uire

d a

re-o

pera

tion.

- Q

ualit

y of

life

was

eva

luat

ed b

ased

on

the

BA

RO

S sc

ore¶

in 3

48 p

atie

nts 2

, 3 a

nd 5

yea

rs a

fter s

urge

ry.

- In

pat

ient

s with

out c

o-m

orbi

ditie

s, ou

tcom

es w

ere

good

to

exc

elle

nt fo

r 42

of 6

8 pa

tient

s (61

.7%

) 2 y

ears

afte

r su

rger

y, a

nd fo

r 29

of 4

0 pa

tient

s (72

.5%

) 3 y

ears

afte

r su

rger

y.-

In p

atie

nts w

ith c

o-m

orbi

ditie

s, ou

tcom

es w

ere

good

to

exce

llent

for 2

50 o

ut o

f 280

pat

ient

s (89

%) 2

yea

rs a

fter

surg

ery,

and

for 1

57 o

ut o

f 177

pat

ient

s (88

.7%

) 3 y

ears

af

ter s

urge

ry.

71

TAB

LE E

-1

Swed

ish

adju

stab

le g

astr

ic b

andi

ng (c

ont’d

)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

INIT

IAL

WEI

GH

T AN

D B

MI

AOT

(MIN

)AL

OS

(DAY

S)CO

MPL

ICAT

ION

SO

UTC

OM

ES

Func

tiona

l com

plic

atio

ns++

: 7%

(58

of 8

24 p

atie

nts i

n 5

year

s)P

rim

ary

band

into

lera

nce:

1%

(8)

Seco

ndar

y ba

nd in

tole

ranc

e: 6

.1%

(50)

Con

vers

ions

: 5.2

% (8

24 p

atie

nts)

; 2.1

%

betw

een

2000

and

200

1

Dea

ths:

0%

at 1

mon

th; 0

.4%

** a

t 1 m

onth

Aut

hors

’ com

men

ts:

The

auth

ors c

oncl

ude

that

LSA

GB

is e

ffi ca

ciou

s, w

ith a

ccep

tabl

e co

mpl

icat

ion

and

mor

talit

y ra

tes.

* C

onsi

dera

tion

is g

iven

onl

y to

leak

s pro

duce

d w

ith th

e 2n

d-ge

nera

tion

SAG

Bs;

32%

of t

he 1

st-g

ener

atio

n SA

GB

s im

plan

ted

betw

een

Apr

il 19

96 a

nd M

arch

199

7 w

ere

repl

aced

bec

ause

of a

leak

at

the

seam

.†

One

ear

ly a

nd o

ne la

te b

and

infe

ctio

n.‡

Ban

d sl

ippa

ges o

ccur

red

betw

een

the

10th

and

the

48th

pos

t-ope

rativ

e m

onth

s, w

ith a

pea

k in

cide

nce

durin

g th

e 2n

d an

d 3r

d po

st-o

pera

tive

year

s.§

Ban

d er

osio

ns o

ccur

red

betw

een

the

11th

and

the

42nd

mon

ths.

|| Mos

t of t

he c

ompl

icat

ions

occ

urre

d du

ring

the fi r

st tw

o po

st-o

pera

tive

year

s (3.

2% a

nd 2

.2%

). Th

ese

com

plic

atio

ns d

ropp

ed to

1.7

% (3

rd y

ear)

, to

1.0%

(4th

yea

r) a

nd to

0%

(5th

yea

r).

¶ B

AR

OS

(Bar

iatri

c Ana

lysi

s and

Rep

ortin

g O

utco

me

Syst

em).

This

syst

em is

bas

ed o

n th

e sc

orin

g of

pat

ient

s’ qu

ality

of l

ife, E

WL,

com

plic

atio

ns a

nd im

prov

emen

t in

co-m

orbi

ditie

s. **

Co-

mor

bidi

ties c

ause

d 2

deat

hs, a

nd th

e 3r

d pa

tient

die

d fo

llow

ing

sept

ic c

ompl

icat

ion

afte

r con

vers

ion

to g

astri

c by

pass

(ban

d in

tole

ranc

e).

++ T

he a

utho

rs d

efi n

e pr

imar

y ba

nd in

tole

ranc

e as

tota

l sol

id-f

ood

into

lera

nce

with

an

empt

y ba

nd. S

econ

dary

ban

d in

tole

ranc

e is

cha

ract

eriz

ed b

y a

tota

l or s

ubto

tal s

olid

-foo

d in

tole

ranc

e at

min

imal

ba

nd fi

lling

, ind

ucin

g or

mai

ntai

ning

wei

ght l

oss.

72

TAB

LE E

-2

Com

pari

sons

bet

wee

n tw

o la

paro

scop

ic g

astr

ic-b

andi

ng t

echn

ique

s

AUTH

OR

STY

PE O

F PR

OCE

DU

RE

NU

MB

ER

OF

PATI

ENTS

WEI

GH

T(K

G)

EXCE

SS

WEI

GH

T(K

G)

BM

I(K

G/M

2)

AOT

(MIN

)AL

OS

(DAY

S)FO

LLO

W-U

P(M

ON

THS)

COM

PLIC

ATIO

NS

OU

TCO

MES

Wei

ner

et a

l.,20

01(R

C)

Ret

roga

stric

pl

acem

ent o

f LA

GB

(Bel

ache

w a

nd

Cal

dier

e)

5114

5.8

± 17

.466

.2 ±

10.

248

.5 ±

3.4

58.2

± 4

.84.

9 ±

0.8

18Po

st-o

pera

tive

com

plic

atio

ns: 3

(p <

0.0

01)

Rel

ated

to p

ort s

ites:

4 (N

S)R

elat

ed to

the

band

: 3 (p

< 0

.001

)-

Slip

page

: 2 (p

< 0

.001

)-

Pouc

h di

lata

tion:

1 (p

< 0

.05)

- Es

opha

geal

dila

tatio

n: 1

(dia

met

er >

30

mm

)O

ther

sym

ptom

s:

- H

unge

r sen

satio

n: 3

- D

ysph

agia

: 1-

Rec

urre

nt v

omiti

ng: 1

Dea

ths:

0

Wei

ght

loss

(gra

phic

ally

dep

icte

d da

ta)

Ret

roga

stric

pl

acem

ent:

(n =

50)

- 1

year

: 37

kg-

18 m

onth

s: >

40

kg

Esop

hago

gast

ric

plac

emen

t: (n

= 4

9)

- 1

year

: 34

kg-

18 m

onth

s: >

40

kg

Esop

hago

gast

ric

plac

emen

t of

LAG

B

(Wei

ner)

5014

2.9

± 14

.369

.7 ±

12.

349

.5 ±

4.2

56.5

± 5

.24.

5 ±

0.4

Post

-ope

rativ

e co

mpl

icat

ions

:

Rel

ated

to p

ort s

ites:

0R

elat

ed to

the

band

: 0

Esop

hage

al d

ilata

tion:

1(d

iam

eter

> 3

0 m

m)

Oth

er sy

mpt

oms:

-

Hun

ger s

ensa

tion:

1-

Dys

phag

ia: 1

- R

ecur

rent

vom

iting

: 1

Dea

ths:

0

73

TAB

LE E

-2

Com

pari

sons

bet

wee

n tw

o la

paro

scop

ic g

astr

ic-b

andi

ng t

echn

ique

s (co

nt’d

)

AUTH

OR

STY

PE O

F PR

OCE

DU

RE

NU

MB

ER

OF

PATI

ENTS

WEI

GH

T(K

G)

EXCE

SS

WEI

GH

T(K

G)

BM

I(K

G/M

2)

AOT

(MIN

)AL

OS

(DAY

S)FO

LLO

W-U

P(M

ON

THS)

COM

PLIC

ATIO

NS

OU

TCO

MES

Wei

ss

et a

l.,20

02(R

C)

Con

vent

iona

l pl

acem

ent o

f LA

GB

(The

ban

d is

pl

aced

from

1 to

3

cm b

elow

the

low

er e

soph

agea

l sp

hinc

ter,

base

d on

For

sell’

s te

chni

que.

)

28

(24

fem

ales

an

d 4

mal

es)

Uns

pecifi e

dU

nspe

cifi e

d42

.5(3

9.3–

47.3

)77

(55–

152)

3.2

(3–1

0)23

(20–

26)

Con

vers

ions

: 3.6

%

Re-

oper

atio

ns:

10.7

%(3

cas

es, i

nclu

ding

1 o

pen

surg

ery)

- B

and

mig

ratio

n in

to

the

stom

ach:

1-

Pouc

h di

lata

tion:

1-

Port

disc

onne

ctio

n: 1

Oth

er sy

mpt

oms:

-

Dys

phag

ia: 0

%-

Hea

rtbur

n: 1

1.1%

BM

I (k

g/m

2 )

25.1

(22.

4–36

.3)

Esop

hago

gast

ric

plac

emen

t of

LAG

B

(The

ban

d is

pl

aced

aro

und

the

esop

hagu

s an

d th

eref

ore

over

laps

the

low

er e

soph

agea

l sp

hinc

ter,

base

d on

Niv

ille’

s te

chni

que.

)

26

(23

fem

ales

an

d 3

mal

es)

Uns

pecifi e

dU

nspe

cifi e

d41

.8(3

9–44

.1)

82(6

5–16

0)3.

5(3

–10)

24(2

0–26

)C

onve

rsio

ns:

3.8%

Re-

oper

atio

ns:

19.2

%(5

cas

es, i

nclu

ding

1 o

pen

surg

ery)

- Ea

rly b

and

mig

ratio

n in

to

the

esop

hagu

s: 1

- La

te b

and

mig

ratio

n in

to th

e es

opha

gus:

1-

Port

disl

ocat

ion:

1-

Psyc

holo

gica

l pro

blem

s: 1

Oth

er sy

mpt

oms:

-

Dys

phag

ia: 5

7.1%

-

Hea

rtbur

n: 1

4.3%

22.9

(21.

9–35

)

74

TAB

LE E

-3

Com

pari

sons

bet

wee

n th

e L

ap-B

and

and

Hel

ioga

st b

ands

AUTH

OR

STY

PE O

F PR

OCE

DU

RE

NU

MB

ER O

F PA

TIEN

TSB

MI

(KG

/M2

)AO

T(M

IN)

COM

PLIC

ATIO

NS

OU

TCO

MES

Bla

nco-

Enge

rt et

al.,

200

3(R

C)

LAG

B(L

ap-B

and®

)30

43.4

50

Lap-

Ban

d H

elio

gast

Slip

page

0

0M

igra

tion

0 1

(3.3

%) (

NS)

Def

ects

0

3 (1

0%) (

NS)

Inad

equa

te

stom

a si

ze

0 26

(87%

) (p

< 0.

0001

)O

ther

1*

8† (

p =

0.02

37‡ )

- 14

of th

e 26

pat

ient

s, in

who

m it

was

not

pos

sibl

e to

re

ach

a fu

nctio

nal s

tom

a si

ze, p

rese

nted

with

sym

ptom

s su

ch a

s pai

n, n

ause

a, b

rady

card

ia a

nd sw

eatin

g, a

fter

an in

crea

se in

the fi l

l vol

ume

from

5 to

9 c

c. T

hese

sy

mpt

oms w

ere

pres

umab

ly d

ue to

vag

us re

actio

ns

caus

ed b

y in

crea

sed

pres

sure

on

the

sutu

red

stom

ach.

- In

the

Hel

ioga

st g

roup

, 3 re

-ope

ratio

ns (L

RYG

B) w

ere

perf

orm

ed (1

bec

ause

of a

n ul

cer a

nd in

fect

ion

and

2 af

ter b

and

dila

tatio

n ag

grav

ated

by

atte

mpt

s to

incr

ease

th

e ba

nd v

olum

e).

%

EW

L

Lap-

Ban

d H

elio

gast

p

valu

e1

mon

th

4.2

± 0

.86

4.8

± 0

.55

0.00

473

mon

ths

12.2

± 1

.30

9.4

± 1

.39

0.00

016

mon

ths

26.4

± 2

.88

17.1

± 1

.65

0.00

0112

mon

ths

41.7

± 2

.71

28.3

± 2

.40

0.00

01

- At 6

mon

ths,

the

perc

enta

ge o

f exc

ess w

eigh

t los

s in

the

Hel

ioga

st g

roup

was

low

er th

an th

at in

the

Lap-

Ban

d gr

oup.

The

diff

eren

ce is

sign

ifi ca

nt.

- The

com

plic

atio

n ra

te w

as si

gnifi

cant

ly h

ighe

r in

the

Hel

ioga

st g

roup

.

LAG

B(H

elio

gast

®)

30

3 (1

st

gene

ratio

n:

larg

e)

27 (2

nd

gene

ratio

n:

med

ium

)

41.2

54

* 1

band

rupt

ure

(3.3

%).

† 6

case

s of b

and

rota

tion

(20%

) and

2 c

ases

of i

nfec

tion

(one

afte

r a re

visi

on a

nd th

e ot

her a

ssoc

iate

d w

ith b

and

mig

ratio

n).

‡ Th

e di

ffere

nce

is si

gnifi

cant

onl

y fo

r ban

d ro

tatio

n.

75

TAB

LE E

-4

Lap

aros

copi

c ad

just

able

gas

tric

ban

ding

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I (K

G/M

2)

FOLL

OW

-UP

(MO

NTH

S)CO

MPL

ICAT

ION

S O

UTC

OM

ES

Ang

risan

iet

al.,

20

04a

(R)

LAG

B(L

ap-B

and)

- In

itial

ly, 3

562

patie

nts o

pera

ted

betw

een

Janu

ary

1996

and

200

3 in

26

cen

tres i

n Ita

ly

- 57

3 pa

tient

s (4

51 fe

mal

es a

nd

122

mal

es) w

ere

follo

wed

for 5

yea

rs

(ope

rate

d be

twee

n Ja

nuar

y 19

96 a

nd

Dec

embe

r 199

7).

Thes

e pa

tient

s wer

e gr

oupe

d ac

cord

ing

to th

eir p

re-o

pera

tive

BM

Is.

Gro

up A

(n =

166

)

30–3

9.9

(1

38 M

/ 25

8 F)

Mea

n ag

e:36

.9 ±

12.

1 ye

ars

(18–

61)

Gro

up B

(n =

302

)

40–4

9.9

(6

1 M

/ 24

1 F)

Mea

n ag

e:37

.8 ±

10.

9 ye

ars

(21–

63)

Gro

up C

(n =

96)

50–5

9.9

(19

M /

77 F

)M

ean

age:

39 ±

12.

5 ye

ars

(18–

74)

Gro

up D

(n =

9)

≥ 60

(1

M /

8 F)

Mea

n ag

e:37

.1 ±

14.

7 ye

ars

(23–

65)

5-ye

ar d

ata

avai

labl

e on

38

1 pa

tient

sG

roup

sA

BC

DN

umbe

r of

patie

nts

T =

573

166

302

969

Gas

tric-

pouc

h di

latio

n

T =

24

(4. %

)

12(7

.2%

)p

< 0.

05

10(3

.3%

)1

(1%

)1

(11.

1%)

p <

0.01

Intra

gast

ric

band

m

igra

tion/

eros

ion

T =

12

(2.1

%)

3(1

.8%

)6

(1.9

%)

3 (3

.1%

)p

< 0.

01

0

Post

-op

erat

ive

mor

talit

y ra

teT

= 5

(0.8

7%)

1(0

.6%

)1

(0.3

%)

3 (3

.1%

)0

Con

vers

ions

to o

ther

type

s of b

aria

tric

surg

ery:

1.

4% (8

/573

)

Rem

oval

of g

astri

c ba

nd: 4

.2%

(24/

573)

Gro

ups

AB

CD

Num

ber

of p

atie

nts

T =

381/

573

(66.

5 %

)

96/1

66(5

7.8%

)21

4/30

2(7

0.8%

)64

/96

(66.

6%)

7/9

(77.

7%)

Initi

al B

MI

(kg/

m2 )

T =

30.2

± 8

.3

27.5

± 5

231

.6 ±

4.7

37.6

± 1

7.3

41.4

± 6

.9

Lost

BM

I(k

g/m

2 )

T =

12 ±

6

9.8

± 5.

412

.9 ±

5.2

15.8

± 8

.123

.2 ±

4.9

EWL

(%)

T =

54.8

± 2

2.3

54.6

± 3

2. 3

54.1

± 1

7.2

51.6

± 3

559

.1 ±

17.

1

< 25

% E

WL

T =

22/3

65(6

%)

9(9

.7%

)4

(1.9

%)

p <

0.05

9(9

.3 %

)0

< 50

% E

WL

T =

91/3

65

(24.

9 %

)

17(1

8.4%

)51

(24.

8%)

23(2

3.9%

)0

76

TAB

LE E

-4

Lap

aros

copi

c ad

just

able

gas

tric

ban

ding

(con

t’d)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I OR

INIT

IAL

WEI

GH

T FO

LLO

W-U

P (M

ON

THS)

AOT

(MIN

)AL

OS

(DAY

S)CO

MPL

ICAT

ION

S O

UTC

OM

ES

Ang

risan

iet

al.,

20

04b

(R)

Ret

rosp

ectiv

e,

mul

ticen

tre st

udy

of 2

10 o

f 33,

129

Lap-

Ban

d pa

tient

s bet

wee

n Ja

nuar

y 19

96 a

nd

Dec

embe

r 200

2

176

wom

en a

nd

34 m

en

Age

:38

.9 ±

11.

8 ye

ars

(17–

66)

BM

I ≤ 3

5 kg

/m2

Co-

mor

bidi

ties:

10

9 in

55

patie

nts

33.9

± 1

.1 k

g/m

2

(25.

1–35

)

Exce

ss w

eigh

t:29

.7 ±

7.1

kg

(8–4

1)

6–60

––

Tube

-por

t lea

k: 4

- tub

e-po

rt re

conn

ectio

n: 2

- p

ort r

epla

cem

ent:

2

Pouc

h di

lata

tion:

11

- ban

d defl a

tion:

5- b

and

repo

sitio

ning

: 2- b

and

rem

oval

: 2

Intra

gast

ric m

igra

tion:

2

- ban

d re

mov

al: 1

Dea

ths:

1(a

t 20

mon

ths f

ollo

win

g se

ptic

emia

cau

sed

by

perf

orat

ion

of th

e ga

stric

po

uch)

Follo

w-u

pEW

L (%

)B

MI

(kg/

m2 )

6 m

onth

s (n

= 21

0/21

0)28

.1 ±

20.

731

.1 ±

2.1

51

year

(n =

182

/197

)52

.5 ±

13.

229

.7 ±

2.1

92

year

s (n

= 11

9/14

8)61

.3 ±

14.

728

.7 ±

3.8

3 ye

ars (

n =

75/9

9)64

.7 ±

12.

226

.7 ±

4.3

4 ye

ars (

n =

49/7

3)68

.8 ±

15.

327

.9 ±

3.2

5 ye

ars (

n =

21/2

9)71

.9 ±

10.

728

.2 ±

0.9

Bef

ore

Afte

r(1

yea

r)Su

cess

(%)

Anx

iety

and

dep

ress

ion

472

95.8

Ost

eoar

thro

path

y43

490

.8H

yper

tens

ion

91

88.9

Gas

tro-e

soph

aege

al

refl u

x di

seas

e5

010

0

Non

-insu

lin-d

epen

dent

di

abet

es4

010

0

Res

pira

tory

dis

orde

rs1

10

At o

ne y

ear,

all c

o-m

orbi

ditie

s had

bee

n re

solv

ed in

49

of th

e 55

pat

ient

s (89

.1%

)

77

TAB

LE E

-4

Lap

aros

copi

c ad

just

able

gas

tric

ban

ding

(con

t’d)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I OR

INIT

IAL

WEI

GH

T FO

LLO

W-U

P (M

ON

THS)

AOT

(MIN

)AL

OS

(DAY

S)CO

MPL

ICAT

ION

SO

UTC

OM

ES

Bel

ache

w

et a

l.,19

98(R

)

550

43.0

kg/

m2

6062

Not

ava

ilabl

eE

arly

com

plic

atio

ns: 0

.4%

*- G

astri

c pe

rfor

atio

n: 1

Late

com

plic

atio

ns:

- Pou

ch d

ilata

tion:

28

- Ban

d er

osio

n: 1

8

Re-

oper

atio

ns: 5

6%

Dea

ths:

0

EWL:

50%

Bel

ache

wet

al.,

20

02(R

)

763:

Lap

-Ban

d(3

cen

tres)

42 k

g/m

2

(35–

65)

Ove

r 48

patie

nts

(90%

of p

atie

nts)

U

nspe

cifi e

dU

nspe

cifi e

dE

arly

com

plic

atio

ns:

- Gas

tric

perf

orat

ion:

0.5

%- L

arge

-bow

el p

erfo

ratio

n: 0

.1%

- Ble

edin

g: 0

.1%

Late

com

plic

atio

ns:

- Ban

d er

osio

n: 0

.9%

- Foo

d in

tole

ranc

e: 8

%- A

cces

s-po

rt pr

oble

ms:

2.5

%

(11.

1% re

-ope

rate

d)- C

onve

rsio

ns: 1

.3%

Dea

ths:

0.1

%

BM

I: 30

kg/

m2 at

4 y

ears

(2

8.6%

dec

reas

e)

EWL:

6 m

onth

s: 3

0%

1 ye

ar: 4

0%2

year

s: 5

0%4

year

s: 5

0–60

%

Dar

gent

,19

99(R

)

500

43.0

kg/

m2

(36–

60)

28N

ot a

vaila

ble

Not

ava

ilabl

eE

arly

com

plic

atio

ns:

0.8%

- Gas

tric

perf

orat

ion:

1- B

and

mig

ratio

n: 2

Late

com

plic

atio

ns:

- Pou

ch d

ilata

tion:

25

- Ban

d er

osio

n: 3

- Acc

ess-

port

com

plic

atio

ns: 5

Re-

oper

atio

ns:

3.6%

Dea

ths:

0

EWL:

6 m

onth

s: 4

5% (n

= 4

43)

1 ye

ar: 5

6% (n

= 2

70)

2 ye

ars:

65%

(n =

96)

3 ye

ars:

64%

(n =

19)

* Ex

clud

ing

food

into

lera

nce.

78

TAB

LE E

-4

Lap

aros

copi

c ad

just

able

gas

tric

ban

ding

(con

t’d)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I OR

INIT

IAL

WEI

GH

T FO

LLO

W-U

P (M

ON

THS)

AOT

(MIN

)AL

OS

(DAY

S)CO

MPL

ICAT

ION

SO

UTC

OM

ES

DeM

aria

et

al.,

2001

(R)

Lap-

Ban

d: 3

744

.5 ±

4 k

g/m

2

276

± 38

lbs

12–4

8U

nspe

cifi e

dU

nspe

cifi e

d- E

soph

agea

l dila

tatio

n: 7

1%- B

and

mig

ratio

n: 8

.5%

- Lea

kage

: 5.4

%- I

nfec

tion:

5.4

%

- Con

vers

ions

: 2.7

%- D

eath

s: 0

Follo

w-u

pB

MI

(kg/

m2 )

EWL

12 m

onth

s (n

= 28

)37

.0 ±

634

.5 ±

20%

24 m

onth

s (n

= 24

)37

.2 ±

736

± 2

3%

36 m

onth

s (n

= 15

)35

.8 ±

638

± 2

7%

48 m

onth

s (n

= 4)

3444

%

Dix

on

and

O’B

rien,

20

02(R

)

LSA

GB

: 50

patie

nts

with

type

2 d

iabe

tes

from

a c

ohor

t of 5

00

cons

ecut

ive

patie

nts

48.2

± 8

kg/

m2

137

± 30

kg

12U

nspe

cifi e

dU

nspe

cifi e

dE

arly

com

plic

atio

ns (6

% o

f pat

ient

s)- I

nfec

tion:

4%

- Res

pira

tory

: 2%

Late

com

plic

atio

ns:

30%

- Sto

mac

h pr

olap

se: 2

0%- B

and

eros

ion:

6%

- Lea

kage

: 4%

- Con

vers

ions

: 0

At 1

yea

r:- B

MI:

38.7

± 6

kg/

m2

- Wei

ght:

110

± 24

kg

- EW

L: 3

8 ±

14%

(47

± 17

%) (

coho

rt of

50

0 pa

tient

s)

Rem

issi

on o

f dia

bete

s in

32 p

atie

nts

(unc

hang

ed o

r hig

h gl

ycem

ic c

ontro

l in

18 p

atie

nts)

Impr

oved

qua

lity

of li

fe fo

r 34

of th

e la

st

35 o

pera

ted

patie

nts

Favr

etti

et a

l.,19

98(R

)

180

45.5

kg/

m2

1880

2–3

Ear

ly c

ompl

icat

ions

:

- Per

fora

tion:

1- B

and

mig

ratio

n: 1

Late

com

plic

atio

ns:

- Ban

d m

igra

tion:

6- B

and

eros

ion:

1

Re-

oper

atio

n: 2

.8%

Dea

ths:

0

BM

I:6

mon

ths:

37

kg/m

2 18

mon

ths:

35

kg/m

2

79

TAB

LE E

-4

Lap

aros

copi

c ad

just

able

gas

tric

ban

ding

(con

t’d)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I OR

IN

ITIA

L W

EIG

HT

FOLL

OW

-UP

(MO

NTH

S)AO

T(M

IN)

ALO

S(D

AYS)

COM

PLIC

ATIO

NS

OU

TCO

MES

Fiel

ding

et a

l.,

1999

(R)

335

46.7

kg/

m2

(34–

86)

1871

1.4

Ear

ly c

ompl

icat

ions

: 2.

1%

- Inf

ectio

n: 4

- Ban

d m

igra

tion:

2

Late

com

plic

atio

ns:

- Ban

d m

igra

tion:

12

- Acc

ess-

port

com

plic

atio

ns: 5

Dea

ths:

0

EWL:

12

mon

ths:

52%

(n =

125

)18

mon

ths:

62%

(n =

58)

Gre

enst

ein

et a

l.,19

99(P

)

250

48 k

g/m

260

Uns

pecifi e

dU

nspe

cifi e

dC

ompl

icat

ions

: 5.6

% (1

3 ca

ses)

Dea

ths:

1

EWL:

40

kg (m

ean)

Gus

tavs

son

and

Wes

tling

,20

02(R

)

90

(199

4–19

96)

43 k

g/m

284

Uns

pecifi e

dU

nspe

cifi e

d58

% o

f pat

ient

s req

uire

d re

-ope

ratio

nB

MI a

t 5 y

ears

: 33

.7 k

g/m

2 (24

–44)

Mill

er a

nd

Hel

l,19

99(N

CC

)

A: 1

02 (s

ilico

ne)

B: 5

4 (S

wed

ish)

45 k

g/m

2

43 k

g/m

228

(1.5

–46)

Uns

pecifi e

dA

: 4.3

B: 3

.3E

arly

com

plic

atio

ns:

- Sili

cone

: hem

atom

a (1

) - S

wed

ish:

wou

nd in

fect

ion

(1)

Late

com

plic

atio

ns:

- Sili

cone

: pou

ch d

ilata

tion

(2);

band

rupt

ure

(2)

- Sw

edis

h: p

ouch

dila

tatio

n (1

); ba

nd e

rosi

on (1

); ac

cess

-por

t com

plic

atio

ns (1

); re

-ope

ratio

ns (7

%)

Dea

ths:

0

BM

I:1

year

: 34

kg/m

2 3

year

s: 2

8 kg

/m2

80

TAB

LE E

-4

Lap

aros

copi

c ad

just

able

gas

tric

ban

ding

(con

t’d)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I OR

IN

ITIA

L W

EIG

HT

FOLL

OW

-UP

(MO

NTH

S)AO

T(M

IN)

ALO

S(D

AYS)

COM

PLIC

ATIO

NS

OU

TCO

MES

Neh

oda

et a

l.,20

01(R

)

320

(LSA

GB

)44

.29

kg/m

2

127.

8 kg

12(6

–28)

Uns

pecifi e

dU

nspe

cifi e

dR

e-op

erat

ions

: 10.

3%EW

L: 6

8% (3

1.0

kg: 4

.3 k

g/m

onth

the fi r

st 3

mon

ths)

Impr

oved

qua

lity

of li

fe

in 9

7% o

f cas

es

O’B

rien

et a

l.,19

99(P

)

277

of 3

02(L

ap-B

and)

44.5

kg/

m2

4857

(45–

110)

3.9

(1–7

)E

arly

com

plic

atio

ns: 4

.3%

(ban

d m

igra

tion)

Late

com

plic

atio

ns:

- Her

nia:

27

- Eso

phag

itis:

1

Dea

ths:

0

EWL:

1

year

: 51.

0 ±

17%

(n =

120

)2

year

s: 5

8.3

± 20

% (n

= 4

3)3

year

s: 6

1.6

± 2%

(n =

25)

4 ye

ars:

68.

2 ±

21%

(n =

12)

Rub

enst

ein,

2002

(R

)

63

(46

with

co

-mor

bidi

ties)

(Nov

embe

r 199

6 to

May

199

9)

48.8

kg/

m2

(36.

8–67

)6

(62

patie

nts)

12(5

9 pa

tient

s)

24(1

9 pa

tient

s)

36(1

3 pa

tient

s)

193

± 72

.1(s

tart)

120

± 25

.7(e

nd)

1.4

(1–2

)E

arly

com

plic

atio

ns:

- Gas

tric

perf

orat

ion:

1.5

%

- Acc

ess-

port

prob

lem

s: 7

.9%

Late

com

plic

atio

ns:

Ban

d m

igra

tion:

14.

2% (3

con

verte

d to

gas

tric

bypa

ss a

nd 6

requ

ired

band

rem

oval

); er

osio

n: 1

.5%

(1);

infe

ctio

n: 1

.5%

(1 g

astri

c sy

ndro

me)

Re-

oper

atio

ns:

0

Dea

ths:

0

EWL

6 m

onth

s: 2

7.2

± 14

.2%

1

year

: 38.

3 ±

15.6

%

2 ye

ars:

46.

6 ±

19.5

%

3 ye

ars:

53.

6 ±

23.8

%

81

TAB

LE E

-4

Lap

aros

copi

c ad

just

able

gas

tric

ban

ding

(con

t’d)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I OR

IN

ITIA

L W

EIG

HT

FOLL

OW

-UP

(MO

NTH

S)AO

T(M

IN)

ALO

S(D

AYS)

COM

PLIC

ATIO

NS

OU

TCO

MES

Szol

d an

d A

bu-A

beid

,20

02

(R)

715

(Nov

embe

r 199

6 to

May

199

9)

43.1

kg/

m2

(35–

66)

4878

(36–

165)

1.2

Ear

ly c

ompl

icat

ions

: 1.

1%

(0.8

% in

tra-o

pera

tive)

Late

com

plic

atio

ns: 7

.4%

- Inf

ectio

n: 1

- Ban

d er

osio

n: 3

- Spl

enic

abs

cess

: 2- A

cces

s-po

rt pr

oble

ms:

18

Re-

oper

atio

ns:

57

Dea

ths:

0

26.5

% d

ecre

ase

in in

itial

BM

I in

2 ye

ars

Zim

mer

man

n et

al.,

19

99

(R)

894

(199

5–19

98)

864

(Lap

-Ban

d)

33(S

wed

ish

band

)

42.0

kg/

m2

(35–

72)

(115

with

B

MI >

50)

1235

3.0

Ear

ly c

ompl

icat

ions

: 0.3

3%

- Hep

atic

ble

edin

g: 2

- Pne

umot

hora

x: 2

Late

com

plic

atio

ns:

- Pou

ch d

ilata

tion:

49

- Ban

d ru

ptur

e: 4

8- L

eaka

ge: 5

Re-

oper

atio

ns: 1

8

Dea

ths:

1

B

MI

EWL

(k

g/m

2 ) (%

)6

mon

ths (

n =

676)

35

32 12

mon

ths (

n =

233)

34

40 18

mon

ths (

n =

89)

33

46.5

24 m

onth

s (n

= 47

) 33

39

82

TAB

LE E

-5

Com

pari

sons

bet

wee

n op

en a

nd la

paro

scop

ic a

djus

tabl

e ga

stri

c ba

ndin

g

AUTH

OR

SN

UM

BER

O

F PA

TIEN

TS

BM

I OR

IN

ITIA

L W

EIG

HT

AOT

(MIN

)AL

OS

(DAY

S)FO

LLO

W-U

P(M

ON

THS)

COM

PLIC

ATIO

NS

OU

TCO

MES

De

Wit

et a

l.,19

99(R

C)

AG

B: 2

5W

eigh

t:14

6.4

± 19

.9 k

g

BM

I: 49

.7 ±

5.6

kg/

m2

76 ±

20

7.2

(5–1

3)12

Surg

ical

com

plic

atio

ns:

- Inc

isio

nal h

erni

a: 7

(3 p

atie

nts)

- Ban

d m

igra

tion:

1

Acc

ess-

port

com

plic

atio

ns:

6 (5

pat

ient

s)- R

e-op

enin

g: 1

- Dis

loca

tion:

4- I

nfec

tion:

1

Re-

adm

issi

on:

15 (7

pat

ient

s)

No

deat

hs

At 1

yea

r:

LAG

BA

BG

pth

resh

old

Wei

ght

(kg)

11

7.2

± 25

.211

2.0

± 19

.1ns

Wei

ght

loss

(k

g)35

34.4

ns

BM

I(k

g/m

2 )39

.7 ±

8.7

39.1

± 8

.2ns

- At o

ne y

ear,

no si

gnifi

cant

diff

eren

ces w

ere

foun

d in

th

e nu

mbe

r of p

ost-o

pera

tive

or e

arly

com

plic

atio

ns.

- Wei

ght l

oss w

as si

mila

r in

both

gro

ups.

- LA

GB

was

ass

ocia

ted

with

a sh

orte

r hos

pita

l st

ay a

nd a

low

er re

-adm

issi

on ra

te (s

ignifi c

ant

diffe

renc

es).

LAG

B: 2

5W

eigh

t:15

2.2

± 31

.4 k

g

BM

I: 51

.3 ±

10.

4 kg

/m2

150

± 48

5.9

(4–1

0)Su

rgic

al c

ompl

icat

ions

:- U

mbi

lical

her

nia:

1

Acc

ess-

port

com

plic

atio

ns:

7 (5

pat

ient

s)- R

e-op

enin

g: 2

- Dis

loca

tion:

5

Re-

adm

issi

on:

6 (5

pat

ient

s)

Con

vers

ions

: 2

- Due

to th

e in

abili

ty to

obt

ain

pneu

mop

erito

neum

(adh

esio

ns: 1

; he

pato

meg

aly:

1)

No

deat

hs

83

TAB

LE E

-5

Com

pari

sons

bet

wee

n op

en a

nd la

paro

scop

ic a

djus

tabl

e ga

stri

c ba

ndin

g (c

ont’d

)

AUTH

OR

SN

UM

BER

O

F PA

TIEN

TS

BM

I OR

INIT

IAL

WEI

GH

T AO

T (M

IN)

ALO

S(D

AYS)

FOLL

OW

-UP

(MO

NTH

S)CO

MPL

ICAT

ION

SO

UTC

OM

ES

Doh

erty

et a

l.,

2002

(PN

CC

)

Gro

up 1

: K

usm

ak

AG

B*:

40

(Mar

ch 1

992

to M

ay 1

995)

Mea

n B

MI:

50 k

g/m

2U

nspe

cifi e

dU

nspe

cifi e

dU

p to

96

- In

fect

ed b

and:

16%

-

Obs

truct

ive

aneu

rysm

al d

efor

mity

of

the

infl a

tabl

e bl

adde

r com

pone

nt o

f th

e ba

nd: 3

.2%

(AG

B: 2

) -

Enla

rged

pou

ch w

ith o

bstru

ctiv

e an

gula

tion

of th

e ou

tlet c

hann

el:

17.7

% (A

GB

: 7; L

ap-B

and:

4)

- H

erni

atio

n of

the

dist

al st

omac

h:

22.6

% (A

GB

: 11;

Lap

-Ban

d: 3

)-

30 re

-ope

ratio

ns re

quire

d to

co

rrec

t com

plic

atio

ns re

late

d to

the

impl

ante

d ba

nd

- B

and

rem

oval

in 2

7 ca

ses:

18

in

grou

p 1

and

9 in

gro

up 2

- 9

of 2

6 pa

tient

s com

plai

ned

of fr

eque

nt v

omiti

ng, g

astro

-es

opha

geal

refl u

x an

d ve

ry li

mite

d so

lid-f

ood

choi

ces

Year

12

34

56

78

Gro

up 1

:

Patie

nts

4040

3124

2018

1513

Wei

ght (

kg)

112

112

117

116

122

126

121

123

BM

I39

3833

3641

4440

44

% E

WL

4447

3340

3032

3332

Gro

up 2

:

Patie

nts

1918

1817

1513

Wei

ght (

kg)

118

121

120

128

134

127

BM

I40

4141

4447

43

% E

WL

2728

2517

2115

Gro

up 2

:(L

ap-B

and)

LAG

B: 1

7A

GB

: 5(1

995

to

Janu

ary

7,

1997

)

Mea

n B

MI:

47 k

g/m

2U

p to

72

Frie

d,20

00(R

NC

C)

310

AG

B(1

983–

1993

)B

MI

50.9

kg/

m2

(35.

4–86

.5)

Wei

ght

138.

6 kg

(93.

5–24

8.0)

Uns

pecifi e

d10

.536

(92%

of

patie

nts)

Ear

ly c

ompl

icat

ions

: 6.9

%

- M

ain

wou

nd-r

elat

ed

Late

com

plic

atio

ns:

12.6

%

of w

hich

9.4

% w

ere

hern

ias

- C

onve

rsio

ns o

r re-

oper

atio

ns:

0.6%

pos

t-ope

rativ

e7.

1% la

te

No

deat

hs

3 ye

ars:

LA

GB

A

GB

Mea

n w

eigh

t los

s (kg

): 37

.6

38.4

Mea

n B

MI (

kg/m

2 ):

37.1

36

.8

621

LAG

B(1

993–

1998

)B

MI

47.2

kg/

m2

(37.

6–58

.3)

Wei

ght

141.

3 kg

(90.

8–19

6.5)

2.8

Ear

ly c

ompl

icat

ions

: 1.

0%

- A

cces

s-po

rt co

mpl

icat

ions

Late

com

plic

atio

ns:

0.2%

- C

onve

rsio

ns o

r re-

oper

atio

ns:

1.3%

pos

t-ope

rativ

e6.

3% la

te

No

deat

hs

* In

this

stud

y, A

GB

refe

rs to

the

Kus

mak

type

of a

djus

tabl

e ga

stric

ban

d, a

nd L

ap-B

and

to th

e m

odel

mod

ifi ed

in 1

993.

84

TAB

LE E

-5

Com

pari

sons

bet

wee

n op

en a

nd la

paro

scop

ic a

djus

tabl

e ga

stri

c ba

ndin

g (c

ont’d

)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

BM

I OR

IN

ITIA

L W

EIG

HT

AOT

(MIN

)AL

OS

(DAY

S)FO

LLO

W-U

P(M

ON

THS)

COM

PLIC

ATIO

NS

OU

TCO

MES

Wes

tling

et a

l.,

1998

(RN

CC

)

AG

B: 2

743

kg/

m2

(34–

57)

913

36

A

GB

LA

GB

C

onve

rsio

nsE

arly

com

plic

atio

ns:

- Inc

isio

nal h

erni

a 0

1

–- I

nfec

tion

3 4

–

- Ban

d er

osio

n 1

6

–- E

soph

agiti

s 0

33

–

Late

com

plic

atio

ns:

- Inf

ectio

n 3

4

–- B

and

eros

ion

1 6

3

Dea

ths

0 0

0

Out

com

es a

re n

ot

pres

ente

d by

surg

ical

ap

proa

ch.

BM

I:1

year

: 32

kg/m

2

2 ye

ars:

31

kg/m

2

LAG

B: 6

316

52

Con

vers

ions

: 16

170

4

85

APPE

ND

IX F

O

UTC

OM

ES O

F ST

UD

IES

COM

PAR

ING

DIF

FER

ENT

TYPE

S O

F B

ARIA

TRIC

SU

RG

ERY

TAB

LE F

-1

Com

pari

sons

bet

wee

n bi

liopa

ncre

atic

div

ersi

on a

nd o

ther

typ

es o

f op

en p

roce

dure

s

AUTH

OR

STY

PE O

F PR

OCE

DU

RE

(NU

MB

ER

OF

PATI

ENTS

)

BM

I(K

G/M

2)

AOT

(MIN

)AL

OS

(DAY

S)CO

MPL

ICAT

ION

SM

OR

TALI

TY R

ATE

OU

TCO

MES

:EW

L

Mar

ceau

et

al.,

1998

(RN

CC

)

BPD

-DG

: 252

BPD

-DS:

465

(239

end

-to

-end

an

asto

mos

es,

a te

chni

que

intro

duce

d in

199

2)

46 ±

9(n

= 2

33)

(BPD

)

47 ±

9(n

= 4

57)

(BPD

-DS)

Uns

pecifi e

dA

nnua

l re-

oper

atio

n ra

te:

- BPD

: 1.7

%- B

PD-D

S: 0

.1%

- BPD

: 4%

(4 e

arly

de

aths

, 6 la

te)

- BPD

-DS:

3.8

%

(9 e

arly

dea

ths,

9 la

te)

100

± 20

mon

ths (

BPD

): 61

± 2

2%

(n =

233

)51

± 2

5 m

onth

s (B

PD-D

S): 7

3 ±

21%

(n

= 4

57)

85 ±

3 m

onth

s (B

PD):

63 ±

21%

(1

08 o

pera

ted

in 1

989)

74 ±

4 m

onth

s (B

PD-D

S): 7

0 ±

21%

(5

2 op

erat

ed in

199

0)

Sign

ifi ca

nt d

iffer

ence

: p <

0.0

01

Rab

kin,

1998

(RN

CC

)

BPD

-DG

: 32

RYG

B: 1

38B

PD-D

S: 1

05

45 49 49

Uns

pecifi e

dB

PD: u

nspe

cifi e

dRY

GB

: uns

pecifi e

dB

PD-D

S: 2

per

itoni

tis; 1

thro

mbo

phle

bitis

as

soci

ated

with

pul

mon

ary

embo

lism

; 1

panc

reat

itis;

2 w

ound

infe

ctio

ns; 9

her

nias

; 1

re-o

pera

tion

(dat

a on

the fi r

st 3

7 pa

tient

s)

- BPD

: uns

pecifi e

d- R

YG

B: u

nspe

cifi e

d- B

PD-D

S: 1

dea

th

(alc

ohol

ism

)

24

mon

ths

48 m

onth

sB

PD:

69%

73

%RY

GB

: 74

%

63%

BPD

-DS:

78

%

73%

Baj

ardi

et

al.,

2000

(RN

CC

)

VB

G: 9

3(1

990–

1995

)48

.7(3

7–65

.6)

60(4

2–12

0)9

- Gas

tric

outle

t ste

nosi

s: 2

1.5%

(req

uirin

g ba

nd re

mov

al in

17.

2% o

f cas

es)

- Pos

t-ope

rativ

e he

rnia

: 15%

0%2

year

s: 4

8%

BPD

-DG

: 142

(199

3–19

98)

50(3

5–81

)17

0(9

0–31

5)16

- Pos

t-ope

rativ

e he

rnia

: 24%

- Dee

p ve

nous

thro

mbo

sis:

2.1

%- H

emor

rhag

e: 0

.8%

- Bow

el o

bstru

ctio

n: 0

.8%

- P

ulm

onar

y em

bolis

m: 1

.2%

- Ana

stom

otic

leak

: 0.4

%- M

alnu

tritio

n sy

ndro

me:

19%

(vita

min

s, iro

n, h

ypop

rote

inem

ia)

3.5%

(1 d

eath

due

to

pulm

onar

y em

bolis

m

shor

tly a

fter s

urge

ry,

2 du

e to

chr

onic

he

patit

is a

nd 1

to

perit

oniti

s)

2 ye

ars:

60%

86

TAB

LE F

-2

Com

pari

sons

bet

wee

n ve

rtic

al b

ande

d ga

stro

plas

ty a

nd o

ther

bar

iatr

ic-s

urge

ry t

echn

ique

s

AUTH

OR

STY

PE O

F PR

OCE

DU

RE

BM

I(K

G/M

2)

AOT

(MIN

)AL

OS

(DAY

S)CO

MPL

ICAT

ION

SO

UTC

OM

ES

Cap

ella

and

C

apel

la,

1996

(RN

CC

)

VB

G

(329

ope

ratio

ns

perf

orm

ed o

n 32

8 pa

tient

s)

52 ±

9U

nspe

cifi e

dE

arly

com

plic

atio

ns:

0.3%

(1 c

ase)

Late

com

plic

atio

ns: 9

%

(29

case

s of l

eaka

ge, b

and

disl

ocat

ion

or

pulm

onar

y em

bolis

m)

Dea

ths:

1 d

ue to

pul

mon

ary

embo

lism

EW

L (%

)

BM

I (kg

/m2 )

30–4

2 m

onth

s 48

± 2

3 39

± 9

54–6

6 m

onth

s 47

± 2

3 40

± 9

VB

G-R

YG

B(6

23 o

pera

tions

on 5

60 p

atie

nts

(in 3

51 c

ases

, ga

stric

segm

ents

w

ere

com

plet

ely

sepa

rate

d)

52 ±

9E

arly

com

plic

atio

ns:

1% (6

cas

es)

Late

com

plic

atio

ns:

12%

(7

3 ca

ses o

f fi s

tula

s, ul

cers

and

stap

le-li

ne

disr

uptio

n)

Dea

ths:

0

30–4

2 m

onth

s 70

± 1

9 32

± 6

54–6

6 m

onth

s 62

± 1

7 34

± 6

87

TAB

LE F

-2

Com

pari

sons

bet

wee

n ve

rtic

al b

ande

d ga

stro

plas

ty a

nd o

ther

bar

iatr

ic-s

urge

ry t

echn

ique

s (c

ont’d

)

AUTH

OR

STY

PE O

F PR

OCE

DU

RE

BM

I OR

IN

ITIA

L W

EIG

HT

AOT

(MIN

)FO

LLO

W-U

P(M

ON

THS)

COM

PLIC

ATIO

NS

OU

TCO

MES

Hel

l et a

l.,20

00(P

CC

)

VB

G: 3

0LS

AG

B: 3

0RY

GB

: 30

46.9

± 9

.9 k

g/m

2

46.9

± 7

.8 k

g/m

2

45.2

± 8

.2 k

g/m

2

48 88 135

40.1

± 8

.339

.7 ±

7.6

60 ±

8.1

Agg

rava

tion

of c

linic

al st

atus

in

3%

of R

YG

B p

atie

nts

V

BG

LS

AG

B

RYG

B

(n)

(n)

(n)

EWL

0–24

%

1 1

025

–49%

12

13

2

50–7

4%

15

15

675

–100

%

2 1

22

Hel

l and

M

iller

,20

00

(PN

CC

)

VB

G: 1

01

46.9

± 9

.0 k

g/m

2

133.

7 ±

33.3

kg

Uns

pecifi e

d40

± 8

.3E

arly

com

plic

atio

ns:

- Wou

nd in

fect

ion:

3%

- Hem

atom

a: 1

%

Late

com

plic

atio

ns:

- Eso

phag

ogas

tric

obst

ruct

ion*

: 12%

- Eso

phag

itis:

2%

Con

vers

ions

or

re-o

pera

tions

: 2%

per

yea

r

EWL:

2 ye

ars (

n =

98):

61%

(40

kg)

5 ye

ars (

n =

15):

69%

(48

kg)

Impr

ovem

ent i

n co

-mor

bidi

ties:

B

efor

e A

fter

Type

2 d

iabe

tes

15%

0%

Hyp

erte

nsio

n 50

%

15%

LSA

GB

: 99

46.9

± 7

.8 k

g/m

2

133

± 22

.7 k

gU

nspe

cifi e

d39

.7 ±

7.6

Ear

ly c

ompl

icat

ions

:

- Wou

nd in

fect

ion:

1%

- Hem

atom

a: 1

%

Late

com

plic

atio

ns:

- Ste

nosi

s: 3

%- E

soph

agiti

s: 4

%

Con

vers

ions

or

re-o

pera

tions

:

- 1.8

–3%

per

yea

r

EWL:

2 ye

ars

59%

(46

kg) (

n =

97)

5 ye

ars

71%

(56

kg) (

n =

16)

Impr

ovem

ent i

n co

-mor

bidi

ties:

B

efor

e A

fter

Type

2 d

iabe

tes

15%

0%

Hyp

erte

nsio

n 50

%

15%

* C

ause

d by

the

pass

age

of th

e fo

od b

olus

in p

atie

nts w

ho a

re n

ot u

sed

to th

eir n

ew e

atin

g pa

ttern

s.

88

TAB

LE F

-3

Com

pari

sons

bet

wee

n R

oux-

en-Y

gas

tric

byp

ass

and

lapa

rosc

opic

adj

usta

ble

gast

ric

band

ing

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

WEI

GH

T AN

D

INIT

IAL

BM

I AO

T (M

IN)

ALO

S(M

EDIA

NIN

DAY

S)FO

LLO

W-U

PCO

MPL

ICAT

ION

SO

UTC

OM

ES

Bie

rtho

et a

l.,20

03(R

NC

C)

LRY

GB

: 456

(4

0.2

± 10

.5 y

ears

)W

eigh

t:13

5.4

± 26

.3 k

g(7

6–22

1)

BM

I:49

.4 ±

8.3

kg/

m2

(27–

77)

Uns

pecifi e

d3

± 0.

3 (2

–94)

3 m

onth

s (89

%)

6 m

onth

s (88

%)

12 m

onth

s (5

7%)

18 m

onth

s (3

7%)*

Maj

or in

tra-

oper

ativ

e co

mpl

icat

ions

: 2%

- Maj

or le

akag

e of

gas

troje

juna

l an

asto

mos

is: 1

- Rou

x lim

b to

o sh

ort:

3- E

nd-to

-end

ana

stom

osis

dev

ice

pulle

d th

roug

h st

omac

h: 1

- Nas

ogas

tric

tube

stap

led:

1

Ear

ly p

ost-

oper

ativ

e co

mpl

icat

ions

: 4.

2%- M

ajor

leak

age

of g

astro

jeju

nal

anas

tom

osis

: 6- D

eep

veno

us th

rom

bosi

s: 4

- Gas

tric

dila

tatio

n: 2

- Int

ra-a

bdom

inal

or i

ntes

tinal

bl

eedi

ng: 2

- Fis

tula

on

Rou

x lim

b: 1

- Pne

umon

ia: 1

- Par

esia

left

arm

: 1

Late

pos

t-op

erat

ive

com

plic

atio

ns:

8.1%

- Ste

nosi

s of g

astro

jeju

nal

anas

tom

osis

: 15

- Lap

aros

copi

c ch

olec

yste

ctom

y: 1

1- O

bstru

ctio

n in

retro

colic

tu

nnel

: 4- P

erfo

ratio

n : 3

- Pan

crea

titis

: 1- O

ther

: 3

Con

vers

ions

: 2%

Dea

ths:

0.4

4% (2

)

EWL

acco

rdin

g to

pre

-ope

rativ

e B

MI:

LR

YG

B

30–4

0 40

–50

50–6

06

mon

ths

55%

56

%

47%

12 m

onth

s 75

%

72%

57

%18

mon

ths

– 81

%

69%

LA

GB

6 m

onth

s 24

%

21%

18

%12

mon

ths

37%

32

%

26%

18 m

onth

s 41

%

40%

33

%

89

TAB

LE F

-3

Com

pari

sons

bet

wee

n R

oux-

en-Y

gas

tric

byp

ass

and

lapa

rosc

opic

adj

usta

ble

gast

ric

band

ing

(con

t’d)

AUTH

OR

SN

UM

BER

OF

PATI

ENTS

WEI

GH

T AN

D

INIT

IAL

BM

I AO

T (M

IN)

ALO

S(M

EDIA

NIN

DAY

S)FO

LLO

W-U

PCO

MPL

ICAT

ION

SO

UTC

OM

ES

Bie

rtho

et a

l.,(c

ont’d

)

LAG

B: 8

05(4

1.7

± 10

.9

year

s)

Wei

ght:

117

± 17

kg

(75–

224)

BM

I: 42

.2 ±

4.9

kg/

m2

(29–

64)

Uns

pecifi e

d5

± 2,

4(2

–22)

3 m

onth

s (97

%)

6 m

onth

s (97

%)

12 m

onth

s (97

%)

18 m

onth

s (97

%)*

Maj

or in

tra-

oper

ativ

e co

mpl

icat

ions

: 1.

3%- B

leed

ing:

4- L

iver

hem

atom

a: 4

- Eso

phag

eal p

erfo

ratio

n: 1

- Ble

edin

g fr

om g

astro

-epi

ploi

c ar

tery

: 1- G

as e

mbo

lism

: 1

Ear

ly p

ost-

oper

ativ

e co

mpl

icat

ions

: 1.

7%- P

neum

onia

: 7- P

ulm

onar

y em

bolis

m: 2

- Por

t hem

atom

a: 2

- Acu

te a

bdom

en: 1

- Por

t inf

ectio

n: 1

Late

pos

t-op

erat

ive

com

plic

atio

ns:

9.1%

- Rel

ated

to th

e ba

nd: 4

6- R

elat

ed to

the

port

or tu

be: 2

3- O

ther

: 4

Con

vers

ions

: 3.

0%

Dea

ths:

0%

* Th

e au

thor

s attr

ibut

e th

e di

ffere

nce

in su

rviv

al ra

tes a

t 18

mon

ths (

37%

and

97%

) to

the

gast

ric-b

ypas

s pro

cedu

re it

self

(whi

ch re

quire

s mor

e as

sess

men

ts, w

here

as th

e pa

tient

s com

e fr

om v

ario

us

regi

ons t

hat a

re so

met

imes

qui

te fa

r), w

hich

mak

es lo

ng-te

rm fo

llow

-up

diffi

cult.

90

APPE

ND

IX G

M

ETA-

ANAL

YSIS

OF

THE

IMPA

CT O

F B

ARIA

TRIC

SU

RG

ERY

ON

O

BES

ITY

CO-M

OR

BID

ITIE

STA

BLE

G-1

Impa

ct o

f ba

riat

ric

surg

ery

on o

besi

ty c

o-m

orbi

diti

es [

Buc

hwal

d et

al.,

200

4]

CO-M

OR

BID

ITIE

SG

RO

UPS

OF

SUR

GIC

ALLY

TR

EATE

D P

ATIE

NTS

*

GAS

TRO

PLAS

TY(M

AIN

LY V

BG

)

RYG

B(IN

CLU

DIN

G

VAR

IAN

TS)

GAS

TRIC

BAN

DIN

G

(AD

JUST

ABLE

AN

D

NO

N-A

DJU

STAB

LE)

BPD

(INCL

UD

ING

VA

RIA

NTS

)

Type

2 d

iabe

tes

Res

olut

ion:

1417

(76.

8) o

f 184

6 st

udy

patie

nts

(63

grou

ps)

Mea

n an

d 95

% C

I: 76

.8%

(70.

7–82

.9%

)p

< 0.

01 (t

est f

or h

eter

ogen

eity

)

Impr

ovem

ent o

r re

solu

tion:

414

(85.

4%) o

f 485

(3

0 gr

oups

) M

ean:

86.

0% (7

8.4–

93.7

%)

p <

0.01

New

or

wor

se:

12 (0

.7%

) of 1

835

(10

grou

ps)

45 (6

8.2%

) of 6

6 (1

1 gr

oups

)

71.6

% (5

5.1–

88.2

%)

p <

0.10

34 (8

9.5%

) of 3

8 (8

gro

ups)

90.8

% (7

6.2–

10.%

)p

< 0.

10

1 (6

.7%

) of 1

5 (1

gro

up)

829

(83.

8%) o

f 989

(2

6 gr

oups

)

83.7

% (7

7.3–

90.1

%)

p <

0.01

115

(90.

6%) o

f 127

(6

gro

ups)

93.2

% (7

9.3–

100%

)p

< 0.

01

6 (0

.5%

) of 1

142

(3 g

roup

s)

98 (4

7.8%

) of 2

05

(9 g

roup

s)

47.9

% (2

9.1–

66.7

%)

p <

0.01

174

(80.

2%) o

f 217

(9

gro

ups)

80.8

% (7

2.2–

89.4

%)

p <

0.10

1 (0

.2%

) of 5

21

(2 g

roup

s)

282

(97.

9%) o

f 288

(6

3 gr

oups

)

98.9

% (9

6.8–

100%

)N

S

89 (8

8.1%

) of 1

01

(6 g

roup

s)76

.7%

(42.

2–10

0%)

p <

0.01

No

data

pro

vide

d

Hyp

erlip

idem

ia†

Hyp

erch

oles

tero

lem

ia†

Hyp

ertri

glyc

erid

emia

†

Impr

ovem

ent:

846

(83.

0%) o

f 101

9(2

3 gr

oups

)M

ean:

79.

3% (6

8.2–

90.5

%)

p <

0.01

1777

(86.

6%) o

f 205

1(1

4 gr

oups

)M

ean:

71.

3% (5

5.5–

87.0

%)

p <

0.01

912

(92.

8%) o

f 983

(1

1 gr

oups

)M

ean:

82.

4% (7

1.1–

93.7

%)

p <

0.01

174

(80.

9%) o

f 215

(7

gro

ups)

73.6

% (6

0.8–

86.3

%)

p <

0.01

40 (3

9.2%

) of 1

02

(4 g

roup

s)38

.4%

(25.

4–51

.4%

)N

S

15 (7

1.4%

) of 2

1 (2

gro

ups)

72.4

% (5

3.4–

91.4

%)

NS

117

(93.

6%) o

f 125

(6

gro

ups)

96.9

% (9

3.6–

100%

)N

S

417

(95.

0%) o

f 439

(5

gro

ups)

94.9

% (9

0.7–

99.1

%)

p <

0.10

255

(94.

1%) o

f 271

(4

gro

ups)

91.2

% (8

3.6–

98.8

%)

p <

0.01

303

(71.

1%) o

f 426

(6

gro

ups)

58.9

% (2

8.2–

89.6

%)

p <

0.01

18 (7

8.3%

) of 2

3 (1

gro

up)

78.0

% (6

1.1–

94.9

%)

NS

10 (7

6.9%

) of 1

3 (1

gro

up)

77.0

% (5

4.1–

99.9

%)

NS

199

(99.

5%) o

f 200

(3

gro

ups)

99.1

% (9

7.6–

100%

)N

S

1234

(99.

7%) o

f 123

8(3

gro

ups)

87.2

% (5

9.2–

100%

)p

< 0.

10

588

(100

%) o

f 588

(2

gro

ups)

100%

(98.

1–10

0%)

NS

91

TAB

LE G

-1

Impa

ct o

f ba

riat

ric

surg

ery

on o

besi

ty c

o-m

orbi

diti

es [

Buc

hwal

d et

al.,

200

4] (c

ont’d

)

CO-M

OR

BID

ITIE

SG

RO

UPS

OF

SUR

GIC

ALLY

TR

EATE

D P

ATIE

NTS

*G

ASTR

OPL

ASTY

(MAI

NLY

VB

G)

RYG

B(IN

CLU

DIN

G

VAR

IAN

TS)

GAS

TRIC

BAN

DIN

G

(AD

JUST

ABLE

AN

D

NO

N-A

DJU

STAB

LE)

BPD

(INCL

UD

ING

VAR

IAN

TS)

Hyp

erte

nsio

nR

esol

utio

n:

3151

(65.

6%) o

f 480

5(6

7 gr

oups

)M

ean:

61.

7% (5

5.6–

67.8

%)

p <

0.01

Impr

ovem

ent o

r re

solu

tion:

1752

(81.

8%) o

f 214

1(4

3 gr

oups

)M

ean:

78.

5% (7

0.8–

98.1

%)

p <

0.01

277

(72.

5%) o

f 382

(2

0 gr

oups

)69

.0%

(59.

1–79

.0%

)p

< 0.

01

83 (8

0.6%

) of 1

03

(12

grou

ps)

85.4

% (7

4.1–

96.7

%)

p <

0.01

1594

(75.

4%) o

f 211

5(2

0 gr

oups

)67

.5%

(58.

4–76

.5%

)p

< 0.

01

379

(87.

1%) o

f 435

(1

1 gr

oups

)87

.2%

(78.

4–95

.9%

)p

< 0.

01

232

(38.

4%) o

f 604

(1

2 gr

oups

)43

.2%

(30.

4–55

.9%

)p

< 0.

01

490

(71.

5%) o

f 685

(1

0 gr

oups

)70

.8 %

(61.

9–79

.6%

)p

< 0.

01

629

(81.

3%) o

f 774

(7

gro

ups)

83.4

% (7

3.2–

93.6

%)

p <

0.10

718

(91.

8%) o

f 782

(7

gro

ups)

75.1

% (4

4.7–

100%

)p

< 0.

01

Slee

p ap

nea

Res

olut

ion:

1051

(87.

9%) o

f 119

5(3

8 gr

oups

)M

ean:

85.

7% (7

9.2–

92.2

%)

p <

0.01

Impr

ovem

ent o

r re

solu

tion:

585

(80.

6%) o

f 726

(2

4 gr

oups

)M

ean:

83.

6% (7

1.8–

95.4

%)

p <

0.01

33 (7

6.7%

) of 4

3 (1

0 gr

oups

)78

.2%

(53.

6–10

0%)

p <

0.01

25 (8

9.3%

) of 2

8 (6

gro

ups)

90.7

% (7

8.5–

100%

)N

S

776

(86.

6%) o

f 896

(1

3 gr

oups

)80

.4%

(68.

4–92

.3%

)p

< 0.

01

167

(94.

9%) o

f 176

(6

gro

ups)

94.8

% (9

1.5–

98.1

%)

NS

53 (9

4.6%

) of 5

6 (5

gro

ups)

95.0

% (8

8.8–

100%

)N

S

10 (5

5.6%

) of 1

8 (3

gro

ups)

68.0

% (2

6.2–

100%

)p

< 0.

10

157

(95.

2%) o

f 165

(6

gro

ups)

91.9

% (8

1.9–

100%

)p

< 0.

01

144

(86.

7%) o

f 166

(6

gro

ups)

71.2

% (3

4.5–

100%

)p

< 0.

01

* In

clud

es R

oux-

en-Y

gas

tric

bypa

ss, g

astri

c ba

ndin

g, g

astro

plas

ty, b

iliop

ancr

eatic

div

ersi

on a

nd m

ixed

gro

ups,

alon

g w

ith o

ther

less

com

mon

pro

cedu

res (

bilia

ry-in

test

inal

byp

ass,

ileog

astro

stom

y,

jeju

no-il

eal b

ypas

s and

uns

pecifi e

d ba

riatri

c su

rger

y).

† Fi

gure

s in

clud

e pa

tient

s w

ho h

ave

elim

inat

ed o

r dec

reas

ed th

eir m

edic

atio

n do

ses,

patie

nts

repo

rted

to h

ave

impr

oved

lipi

d pa

ram

eter

s, an

d al

l pat

ient

s w

ho h

ave

been

clin

ical

ly o

r bio

logi

cally

ev

alua

ted

for i

mpr

ovem

ent.

92

APPE

ND

IX H

D

ETAI

LED

OU

TCO

MES

OF

ECO

NO

MIC

STU

DIE

STA

BLE

H-1

Des

crip

tion

of

stud

ies

on b

aria

tric

sur

gery

wit

h an

eco

nom

ic a

naly

sis

AUTH

OR

S,

COU

NTR

YST

UD

Y D

ESCR

IPTI

ON

MAI

N C

LIN

ICAL

O

UTC

OM

ESM

AIN

ECO

NO

MIC

OU

TCO

MES

MET

HO

DO

LOG

Y D

ETAI

LS

Van

Gem

ert

et a

l., 1

999

Net

herla

nds

(mod

el)

Type

of m

odel

: ret

rosp

ectiv

e be

fore

–afte

r stu

dy c

ombi

ned

with

da

ta o

n th

e co

st o

f the

bur

den

of m

orbi

d ob

esity

in o

rder

to

calc

ulat

e a

cost

-effe

ctiv

enes

s rat

ioN

umbe

r of s

ubje

cts:

21

(con

secu

tive)

Leng

th o

f fol

low

-up:

24

mon

ths

Lost

to fo

llow

-up:

non

eSu

rgic

al te

chni

que:

VB

GB

MI:

47.2

2 ±

7.15

kg/

m2

BM

I: 30

.1 ±

7.1

kg/

m2

(at 1

yea

r)29

.17

± 6.

75 k

g/m

2 (a

t 2 y

ears

)

Δ 12

QA

LYs

Paid

em

ploy

men

t (be

fore

vs a

fter s

urge

ry):

19%

vs 4

8% (p

< 0

.05)

Sick

leav

e: 3

8% v

s 10%

(p <

0.0

5)C

ost o

f sur

gery

: US$

5,86

5C

ost o

f mor

bid

obes

ity: f

rom

US$

9,36

7 (p

reva

lenc

e: 0

.25%

) to

US$

8,30

4 (1

%)

Indi

rect

cos

ts o

f obe

sity

: US$

45,8

79Sa

ving

s: U

S$3,

928–

$4,0

04/Q

ALY

QA

LY: c

ombi

natio

n of

the

resu

lts o

f 3

QoL

que

stio

nnai

res a

nd e

stim

ated

nu

mbe

r of l

ife y

ears

gai

ned

(3.6

ba

sed

on p

ublis

hed

data

)B

urde

n of

obe

sity

: cos

t fi g

ures

from

a

natio

nal s

ourc

eD

isco

unt r

ate:

5%

Non

-incl

usio

n of

follo

w-u

p co

sts a

nd

patie

nts’

pers

onal

exp

ense

s

Sjös

tröm

et a

l.,19

95Sw

eden

(mod

el)

Type

of m

odel

: dat

a fr

om a

non

-ra

ndom

ized

stud

y co

mbi

ned

with

an

eco

nom

ic m

odel

ling

exer

cise

Leng

th o

f fol

low

-up:

24

mon

ths

Dire

ct c

osts

(SEK

) at 1

0 ye

ars p

er

100

patie

nts:

16.5

mill

ion

(sur

gica

l gro

up) v

s 14.

5 m

illio

n (c

ontro

l gro

up)

Prel

imin

ary

data

from

the

SOS

stud

y af

ter t

wo

year

s of f

ollo

w-u

pC

ompl

emen

tary

dat

a fr

om v

ario

us

sour

ces

Nar

bro

et a

l.,19

99

Swed

en(P

CC

)

Num

ber o

f sub

ject

s:

36

9 (S

= su

rger

y)

371

(C =

con

trols

)

Leng

th o

f fol

low

-up:

60

mon

ths (

48

post

-ope

rativ

ely)

Lost

to fo

llow

-up:

0 (d

ata

on si

ck

leav

e or

dis

abili

ty p

ensi

on)

Surg

ical

tech

niqu

e: G

B, V

BG

, AG

BB

MI:

41.6

kg/

m2 (

S); 4

1.0

kg/m

2 (C

)W

eigh

t: 11

9.6

kg (S

); 11

7.1

kg (C

)

Wei

ght l

oss:

S:

30.7

± 1

4.0

kg

(a

t 1 y

ear)

23

.5 ±

15.

3 kg

(at 4

yea

rs)

C:

1.1

± 7.

20 k

g

(at 1

yea

r)

+0.8

± 1

0.1

kg

(a

t 4 y

ears

)

Mea

n nu

mbe

r of s

ick-

leav

e da

ys w

ith

disa

bilit

y pe

nsio

n (S

vs C

):Ye

ar 1

: +50

% (p

< 0

.001

)Ye

ar 3

: –14

% (p

< 0

.01)

Year

4: N

S

Mea

n nu

mbe

r of d

ays o

f dis

abili

ty p

ensi

on

(S v

s C):

Year

1 :

+68%

(C) v

s 81%

(S) (

NS)

Year

s 3 a

nd 4

: S <

C (p

< 0

.05)

Thes

e be

nefi t

s are

sign

ifi ca

ntly

hig

her f

or

subj

ects

age

d 46

.7 a

nd o

lder

.

Med

ian

age:

46.

7 ye

ars

93

TAB

LE H

-1

Des

crip

tion

of

bari

atri

c-su

rger

y st

udie

s w

ith

an e

cono

mic

ana

lysi

s (c

ont’d

)

AUTH

OR

S,

COU

NTR

YST

UD

Y D

ESCR

IPTI

ON

MAI

N C

LIN

ICAL

OU

TCO

MES

MAI

N E

CON

OM

IC O

UTC

OM

ESM

ETH

OD

OLO

GY

DET

AILS

Ägr

en e

t al.,

2002

bSw

eden

(PC

C)

Num

ber o

f sub

ject

s:

510

(S =

surg

ery)

455

(C =

con

trols

)Le

ngth

of f

ollo

w-u

p: 7

2 m

onth

sLo

st to

follo

w-u

p: <

2%

Surg

ical

tech

niqu

e: G

B, V

BG

, AG

BB

MI:

41.8

± 4

.1 k

g/m

2 (S)

; 39

.9 ±

4.6

kg/

m2

(C)

Wei

ght l

oss a

t 6 y

ears

:S:

16.

2 %

± 1

1.6

C: –

0.8%

± 9

.6Pr

opor

tion

S vs

C:

Initi

ally

und

er d

rug

ther

apy:

CV

D: R

R =

0.7

7; p

< 0

.05)

Dia

bete

s: R

R =

0.7

1; p

< 0

.05)

Not

initi

ally

und

er d

rug

ther

apy:

CV

D: R

R =

0.8

0 (N

S)D

iabe

tes:

RR

= 0

.20

(p <

0.0

5)

Varia

tion

in m

edic

atio

n co

sts a

t 6 y

ears

for

subj

ects

initi

ally

und

er d

rug

ther

apy:

- CV

D: –

455

SEK

for w

eigh

t los

s > 1

5%

(p <

0.0

5; c

ompa

rison

in re

latio

n to

w

eigh

t los

s < 5

%)

- Dia

bete

s: –

673

SEK

for w

eigh

t los

s > 1

5%

(p <

0.0

5)

for a

ll su

bjec

ts a

nd b

oth

dise

ases

:- <

15%

: 439

–481

SEK

(77–

97%

)- ≥

15:

–20

SEK

(–7.

8)

Rel

ativ

e w

eigh

t los

s cla

ssifi

ed

acco

rdin

g to

4 c

ateg

orie

s:

< 5;

5–1

0%; 1

0–15

%; ≥

15%

Prop

ortio

n on

med

icat

ion:

dat

aga

ther

ed b

y qu

estio

nnai

re

Indi

vidu

al c

ost f

or e

ach

med

icat

ion,

taki

ng in

to a

ccou

nt

dosa

ge a

nd o

ffi ci

al p

rice

(bas

ed

on d

ecla

red

cons

umpt

ion

durin

g th

e 3

mon

ths p

rior t

o th

e as

sess

men

t)

Ägr

en e

t al.,

2002

aSw

eden

(PC

C)

Num

ber o

f sub

ject

s:

481

(S =

surg

ery)

481

(C =

con

trols

)Le

ngth

of f

ollo

w-u

p: 8

4 m

onth

sLo

st to

follo

w-u

p: 3

% (h

ospi

taliz

atio

n da

ta)

Surg

ical

tech

niqu

es: G

B, V

BG

, AG

BB

MI:

41.9

± 4

.2 k

g/m

2 (S)

; 40

.1 ±

5.0

kg/

m2

(C)

Wei

ght l

oss a

t 6 y

ears

:S:

16.

7% ±

1.8

(401

/481

subj

ects

)C

: –0.

9% ±

10.

1 (3

44/4

81 su

bjec

ts)H

ospi

taliz

atio

n ra

tes:

Year

0: 2

7.7%

(S);1

4.1%

(C)

Year

s 2 to

6: O

R ra

ngin

g fr

om 2

.70

(p <

0.0

001)

to 1

.32

(p =

0.1

1)Ye

ar 0

–6: O

R =

2.7

2 (9

5% C

I: 2.

06–3

.59)

Hos

pita

lizat

ion

days

:Ye

ar 0

: 0.9

(S);

0.7

(C) (

p =

0.42

)Ye

ar 1

(sur

gica

l tre

atm

ent):

9.4

Year

s 1 to

6: 6

.2 (S

); 0.

9 (C

) for

com

mon

po

st-o

p co

nditi

ons:

7.8

(S);

6 (C

) for

oth

er

cond

ition

s

Dis

coun

ted

cost

s in

US$

:Su

rger

y: 4

,207

(S)

Com

mon

pos

t-op

cond

ition

s: 2

,579

(S);

363

(C) (

p <

0.00

1)O

ther

con

ditio

ns: 2

,747

(S);

2,17

7 (C

) (p

= 0

.17)

Tota

l: 9,

553

(S);

2,54

0 (C

) (p

< 0.

001)

Diff

eren

ce b

etw

een

com

mon

he

alth

con

ditio

ns re

late

d to

ba

riatri

c su

rger

y an

d ot

her n

on-

rela

ted

heal

th c

ondi

tions

Dis

coun

t rat

e: 3

%

Mar

tin e

t al.,

1995

Uni

ted

Stat

es(R

NC

C)

Num

ber o

f sub

ject

s:

201

(S =

surg

ery)

161

(C =

con

trols

, med

ical

trea

tmen

t)Le

ngth

of f

ollo

w-u

p: 2

4–84

mon

ths

Lost

to fo

llow

: 75%

(S);

79%

(C) a

t the

5-

year

follo

w-u

p ex

amin

atio

nSu

rgic

al te

chni

que:

RY

GB

BM

I: 49

.3 k

g/m

2 (S)

; 41.

2 kg

/m2 (C

)

Perc

enta

ge o

f pat

ient

s who

redu

ced

thei

r exc

ess w

eigh

t by

at le

ast

one

third

and

who

mai

ntai

ned

this

ou

tcom

e:89

% (S

); 21

% (C

) (at

5 y

ears

)

Uni

t cos

t: U

S$3,

000

vs U

S$24

,000

for

med

ical

trea

tmen

t (C

) and

surg

ical

trea

tmen

t (S

) res

pect

ivel

y

Tota

l cos

ts p

er p

ound

lost

: hig

her v

alue

in th

e co

ntro

l gro

up (fi

gur

es n

ot p

rovi

ded

and

no

stat

istic

al te

st)

Fixe

d un

it co

st c

alcu

late

d ac

cord

ing

to e

stim

ated

fees

ch

arge

d fo

r exa

min

atio

ns a

nd

test

s, m

edic

al tr

eatm

ent a

nd

hosp

italiz

atio

n w

ith su

rgic

al

treat

men

t (ex

clud

ing

treat

men

t fo

r com

plic

atio

ns)

94

TAB

LE H

-1

Des

crip

tion

of

bari

atri

c-su

rger

y st

udie

s w

ith

an e

cono

mic

ana

lysi

s (c

ont’d

)

AUTH

OR

S,

COU

NTR

YST

UD

Y D

ESCR

IPTI

ON

MAI

N C

LIN

ICAL

OU

TCO

MES

MAI

N E

CON

OM

IC O

UTC

OM

ESM

ETH

OD

OLO

GY

DET

AILS

Ngu

yen

et a

l.,20

01U

nite

d St

ates

(RC

)

Num

ber o

f sub

ject

s:

LV

BG

: 79

V

BG

: 76

Leng

th o

f fol

low

-up:

24

mon

ths

Lost

to fo

llow

-up:

num

ber

varie

s acc

ordi

ng to

out

com

e m

easu

re a

nd ti

me

of

mea

sure

men

tSu

rgic

al te

chni

ques

: LV

BG

, V

BG

BM

I:

LVB

G: 4

7.6

± 4.

7 kg

/m2

V

BG

: 48.

4 ±

5.4

kg/m

2

Exce

ss w

eigh

t los

s:LV

BG

: 68

± 15

%V

BG

: 62

± 14

(p =

0.0

7)In

tens

ive

care

:LV

BG

: 6 (7

.6%

)V

BG

: 16

(21.

1%) (

p =

0.03

)R

e-op

erat

ions

: LV

BG

: 6 (7

.6%

)V

BG

: 5 (6

.6%

) (N

S)

Com

pari

sons

bet

wee

n LV

BG

and

VB

G:

Med

ian

hosp

ital l

engt

h of

stay

: 3 v

s 4 d

ays

(p <

0.0

01)

Ope

ratin

g tim

e: 2

25 v

s 195

min

utes

(p <

0.0

01)

Rec

over

y tim

e:-

norm

al a

ctiv

ities

: 8.4

vs 1

7.7

days

(p <

0.0

01)

- w

ork:

32.

2 vs

46.

1 da

ys (p

= 0

.02)

SF-3

6 sc

ores

: som

e di

ffere

nces

at 1

mon

th,

but s

imila

r at 3

mon

ths

BA

RO

S sc

ores

: 97%

vs 8

2% (f

rom

goo

d to

ex

celle

nt)

Tota

l dire

ct c

osts

: US$

7,47

8 vs

US$

7,44

0 (N

S)

- su

rger

y: U

S$4,

922

vs U

S$3,

591

(p <

0.0

1)-

othe

r ser

vice

s: U

S$2,

519

vs U

S$3,

742

(p =

0.0

2)To

tal c

osts

: US$

14,0

87 v

s US$

14,0

98 (N

S)

Inte

ntio

n-to

-trea

t prin

cipl

e

Qua

lity

of li

fe (S

F-36

and

BA

RO

S qu

estio

nnai

res)

Dire

ct su

rger

y co

sts d

istin

guis

hed

from

oth

er h

ospi

tal-s

ervi

ce c

osts

Dire

ct se

rvic

e-ut

iliza

tion

cost

s de

rived

from

a d

ecis

ion

supp

ort

syst

em d

atab

ase

Tota

l cos

ts: i

nclu

de g

ener

al se

rvic

es

Chu

a an

d M

endi

ola,

1995

U

nite

d St

ates

(RN

CC

)

Num

ber o

f sub

ject

s:

a) L

VB

G (1

993–

1994

): 11

b) G

B (1

987–

1992

): 11

c) G

B (1

986)

: 11

Leng

th o

f fol

low

-up:

no

follo

w-

upSu

rgic

al te

chni

ques

: VB

G, G

BB

MI:

a)

48.

2 ±

5.3

kg/m

2

b) 4

6.5

± 6.

79 k

g/m

2

c) u

nspe

cifi e

d

Wei

ght l

oss:

uns

pecifi e

dC

ompl

icat

ions

:

a) n

one

b)

3 su

bjec

ts

c) u

nspe

cifi e

d

Aver

age

leng

th o

f sta

y:

a)

3.9

days

b) 7

.4 d

ays (

afte

r exc

lusi

on o

f one

at

ypic

al c

ase)

c)

7.2

days

Ope

ratin

g tim

e:

a)

202

min

utes

b)

105

min

utes

c)

unsp

ecifi

edH

ospi

tal c

harg

es:

a)

US$

12,8

00b)

US$

16,6

69 (a

fter e

xclu

sion

of o

ne

atyp

ical

cas

e)c)

U

S$14

,131

No

clin

ical

info

rmat

ion

on 1

986

surg

ical

gro

up (c

)

Hos

pita

l cha

rges

: no

deta

ils

prov

ided

on

com

pone

nts o

r dat

a-co

llect

ion

met

hod

Cha

rges

for g

roup

s b) a

nd c

) wer

e co

nver

ted

into

cur

rent

cas

h va

lues

.

95

TAB

LE H

-1

Des

crip

tion

of

bari

atri

c-su

rger

y st

udie

s w

ith

an e

cono

mic

ana

lysi

s (c

ont’d

)

AUTH

OR

S,

COU

NTR

YST

UD

Y D

ESCR

IPTI

ON

MAI

N C

LIN

ICAL

OU

TCO

MES

MAI

N E

CON

OM

IC O

UTC

OM

ESM

ETH

OD

OLO

GY

DET

AILS

Ang

us e

t al.,

2003

Uni

ted

Stat

es(R

NC

C)

Num

ber o

f sub

ject

s:

a) R

YG

B (2

001)

: 122

b) L

RYG

B (2

001)

: 11

Leng

th o

f fol

low

-up:

30

days

Surg

ical

tech

niqu

es: R

YG

B, L

RYG

BB

MI:

a)

55.

32 ±

5.6

4 kg

/m2

b)

49.

54 ±

6.5

1 kg

/m2 (

p <

0.05

)

Blo

od lo

ss (m

l):a)

305

± 8

3b)

125

± 6

8 (p

< 0

.001

)In

tens

ive

care

(no.

of p

atie

nts)

:a)

3

b) 0

Com

plic

atio

ns a

t 30

days

:a)

13%

(16)

b) 4

5% (5

)

Aver

age

leng

th o

f sta

y (d

ays)

: a)

4.8

± 1

.2b)

3.5

± 0

.69

(p <

0.0

01)

Ope

ratin

g tim

e (m

inut

es):

a) 1

55 ±

48

b) 2

85 ±

50

(p <

0.0

01)

Dire

ct c

osts

(US$

):a)

3,1

79 ±

101

b) 4

,180

± 3

82 (p

< 0

.001

)In

dire

ct c

osts

(US$

):a)

2,1

37 ±

285

b) 1

,792

± 2

63 (p

< 0

.001

)To

tal c

osts

(US$

): a)

7,8

94 ±

264

b) 6

,350

± 7

5 (p

< 0

.001

)

Inte

ntio

n-to

-trea

t prin

cipl

e

Cos

ts b

ased

on

hosp

ital c

harg

es

Dire

ct c

osts

: sur

gery

cos

ts

(ope

ratin

g tim

e, o

pera

ting-

room

su

pplie

s, po

st-a

nest

hesi

a ca

re,

excl

udin

g re

usab

le la

paro

scop

ic

equi

pmen

t); h

ospi

tal-s

ervi

ce

cost

s (nu

rsin

g, p

harm

aceu

tical

, ra

diol

ogy)

Indi

rect

cos

ts: h

ouse

keep

ing,

ov

erhe

ad a

nd e

mpl

oyee

ben

efi ts

)

Gal

lagh

er

et a

l.,

2003

Uni

ted

Stat

es(R

)

Num

ber o

f sub

ject

s: 2

5

Tim

e pe

riod

unde

r stu

dy:

3 ye

ars f

or p

re-o

pera

tive

adm

issi

ons,

and

up to

3 y

ears

for

post

-ope

rativ

e ad

mis

sion

s (m

ean

follo

w-u

p of

18

mon

ths)

Surg

ical

tech

niqu

e: R

YG

B

BM

I: 52

± 2

kg/

m2

Age

: 52

± 2

year

s

Sex:

72%

(M);

28%

(F)

Inte

nsiv

e ca

re (d

ays)

: 1.4

± 0

.5

Re-

adm

issi

ons:

6 p

atie

nts f

or

12 a

dmis

sion

s

Cos

t of p

re-o

pera

tive

out

-pat

ient

car

e: 8

± 0

.5 d

ays

Cos

t of p

re-o

pera

tive

out-p

atie

nt c

are

5,47

6 ±

682

(US$

)A

dmis

sion

s 13

,211

± 6

,906

Hom

e-he

alth

dev

ices

1,

383

± 34

9

TOTA

L 10

,558

± 2

,470

Peri-

oper

ativ

e co

sts :

- S

urge

ry

1,90

0 (fi

xe)

- Hos

pita

lizat

ion

7,07

6 ±

497

TOTA

L 8,

976

± 49

7Po

st-o

pera

tive

outp

atie

nt c

are

≈ 1

,800

± 3

00A

dmis

sion

s ≈

5,00

0 ±

1600

TOTA

L 2,

840

± 62

2

Excl

usio

n of

adm

issi

ons a

nd

cons

ulta

tions

not

rela

ted

to

obes

ity o

r to

its c

o-m

orbi

ditie

sSe

rvic

es in

clud

e ho

me-

heal

th

devi

ces.

Cos

t and

oth

er d

ata

are

base

d on

in

form

atio

n pr

ovid

ed b

y th

e ad

min

istra

tive

supp

ort s

ervi

ces o

f th

e su

rger

y de

partm

ent.

Fixe

d un

it co

sts w

ere

assi

gned

to

the

diffe

rent

type

s of s

ervi

ces.

96

TAB

LE H

-1

Des

crip

tion

of

bari

atri

c-su

rger

y st

udie

s w

ith

an e

cono

mic

ana

lysi

s (c

ont’d

)

AUTH

OR

S,

COU

NTR

YST

UD

Y D

ESCR

IPTI

ON

MAI

N C

LIN

ICAL

OU

TCO

MES

MAI

N E

CON

OM

IC O

UTC

OM

ESM

ETH

OD

OLO

GY

DET

AILS

Potte

iger

et

al.,

2004

Uni

ted

Stat

es(R

)

Num

ber o

f sub

ject

s: 5

3 (b

ut 2

exc

lude

d)Fo

llow

-up:

pre

-ope

rativ

e as

sess

men

t, th

en a

t 3-m

onth

and

9-m

onth

in

terv

als p

ost-o

pera

tivel

ySu

rgic

al te

chni

ques

: RY

GB

(30)

and

LR

YG

B (2

1)B

MI g

reat

er th

an 4

0 kg

/m2

Age

: 45

year

s (27

–63)

Sex:

16

mal

es a

nd 3

7 fe

mal

es

Co-

mor

bidi

ties

- D

iabe

tes +

hyp

erte

nsio

nin

34%

of p

atie

nts (

18/5

3)-

Dia

bete

s: 5

5.7%

(29/

53)

- H

yper

tens

ion:

44.

3% (2

4/53

)

Mor

talit

y: 0

Com

plic

atio

ns: 2

5.5%

(13

patie

nts)

Impr

ovem

ent o

r res

olut

ion:

D

iabe

tes:

92%

(47)

Hyp

erte

nsio

n: 7

8% (4

0)

Aver

age

post

-ope

rativ

e st

ay (d

ays)

: 3.

29 ±

20.

7 (5

1/53

)R

educ

tion

in n

umbe

r (n)

and

cos

t (U

S$) o

f m

edic

atio

ns:

Dia

bete

sB

efor

eA

fter

n1.

12 ±

1.1

50.

12 ±

0.4

8U

S$13

6.9

± 20

6.6

26.6

± 1

07.1

Hyp

erte

nsio

n n1.

32 ±

1.2

50.

44 ±

0.6

4U

S$50

.4 ±

59.

9115

.97

± 24

.6To

tal

n2.

44 ±

1.8

60.

56 ±

0.8

1U

S$18

7.24

± 2

37.4

142

.53

± 11

6.6

(for

all

devi

atio

ns: p

< 0

.001

)

Cos

t per

pat

ient

(US$

):H

ospi

tal c

osts

: 10

,508

± 3

,704

Clin

icia

n co

sts:

4,16

8 ±

1,59

5(in

clud

ing

surg

eon)

: 2,

340

± 1,

031

Tota

l cos

ts:

14,6

76 ±

5,2

99

Cos

ts b

ased

on

actu

al c

osts

to

the

med

ical

cen

tre

Hos

pita

l cos

ts: h

ospi

tal s

uppl

ies

and

serv

ices

Clin

icia

n co

sts:

fees

for s

urge

ry,

med

ical

trea

tmen

t and

co

nsul

tatio

ns

Excl

usio

ns: o

ne o

f the

subj

ects

ex

clud

ed (S

ubje

ct 1

) had

slee

p ap

nea

and

chro

nic

obst

ruct

ive

pulm

onar

y di

seas

e an

d w

as

hosp

italiz

ed fo

r 50

days

for

recu

rren

t pne

umon

ia a

nd

pulm

onar

y re

habi

litat

ion;

th

e ot

her e

xclu

ded

subj

ect

(Sub

ject

2) w

as h

ospi

taliz

ed

for 1

36 d

ays f

or a

n an

asto

mot

ic le

ak c

ompl

icat

ed

by a

cute

resp

irato

ry d

istre

ss

synd

rom

e.To

tal c

osts

(US$

):Su

bjec

t 1: 1

35,3

91Su

bjec

t 2: 3

33,8

56

Mon

k et

al.,

20

04U

nite

d St

ates

(R)

Num

ber o

f sub

ject

s: 8

7 of

100

pat

ient

s us

ing

pres

crip

tion

med

icat

ion

pre-

oper

ativ

ely

(but

23

lost

to fo

llow

-up)

Leng

th o

f fol

low

-up:

16

mon

ths

(6–6

0)

Surg

ical

tech

niqu

e: R

YG

BM

ean

BM

I: 57

kg/

m2 (

36.6

–85.

4)A

ge: 4

4 ye

ars (

27–6

4)Se

x: 1

3 m

ales

and

51

fem

ales

Co-

mor

bidi

ties (

64 p

atie

nts)

:- S

leep

apn

ea (3

8)- T

ype

2 di

abet

es (2

3)- H

yper

tens

ion

(31)

- Gas

tro-e

soph

agea

l refl

ux

dise

ase

(21)

- Ast

hma:

23

Slee

p ap

nea:

of t

he 2

5 pa

tient

s who

pr

e-op

erat

ivel

y re

quire

d ai

rway

m

anag

emen

t at n

ight

, onl

y 2

cont

inue

d to

do

so.

Type

2 d

iabe

tes:

21

patie

nts d

isco

ntin

ued

thei

r med

icat

ion

and

2 ot

hers

dec

reas

ed

thei

r dos

ages

by

50%

.H

yper

tens

ion:

11

disc

ontin

ued

thei

r m

edic

atio

n an

d 15

dec

reas

ed th

eir

dosa

ges.

Gas

tro-e

soph

agea

l refl

ux

dise

ase:

5

of th

e 8

patie

nts d

isco

ntin

ued

thei

r med

icat

ions

.A

sthm

a: 1

8 pa

tient

s red

uced

thei

r dos

ages

or

dis

cont

inue

d at

leas

t one

of t

heir

med

icat

ions

.

Med

ical

exp

ense

s ($U

S) re

late

d to

co-

mor

bidi

ties:

Dis

ease

B

efor

e A

fter

Savi

ngs

Slee

p ap

nea

225.

00

18.0

0 20

7.00

Dia

bete

s 75

.60

4.60

71

.00

Hyp

erte

nsio

n 26

.59

10.3

3 16

.26

GER

D

81.7

3 47

.86

33.8

7A

sthm

a 52

.45

32.7

9 19

.66

All

317.

30

135.

20

182.

10

Wilc

oxon

test

: p <

0.0

1

Cos

t of m

edic

atio

n al

one

Excl

usio

n of

pat

ient

s who

di

d no

t use

med

icat

ion

pre-

oper

ativ

ely

Inco

mpl

ete

data

on

23 p

atie

nts

97

TAB

LE H

-1

Des

crip

tion

of

bari

atri

c-su

rger

y st

udie

s w

ith

an e

cono

mic

ana

lysi

s (c

ont’d

)

AUTH

OR

S,

COU

NTR

YST

UD

Y D

ESCR

IPTI

ON

MAI

N C

LIN

ICAL

OU

TCO

MES

MAI

N E

CON

OM

IC O

UTC

OM

ESM

ETH

OD

OLO

GY

DET

AILS

Snow

et a

l.,20

04U

nite

d St

ates

(R)

Num

ber o

f sub

ject

s: 7

8 ov

er th

e ag

e of

54

who

had

bee

n fo

llow

ed a

m

inim

um o

f 6 m

onth

s (ex

tract

ed

from

a d

atab

ase

of 1

060

patie

nts)

Leng

th o

f fol

low

-up:

up

to 2

yea

rs

Surg

ical

tech

niqu

e: L

RYG

B

BM

I: 48

kg/

m2 (

36–7

0)

Wei

ght:

136

kg (8

5–22

6)

Age

: 60

year

s (55

–75)

Sex:

17

mal

es a

nd 6

1 fe

mal

es

Num

ber o

f pat

ient

s with

co

-mor

bidi

ties r

equi

ring

med

icat

ion:

- H

yper

tens

ion

and/

or C

VD

: 51

- Ty

pe 2

dia

bete

s: 2

8-

Pulm

onar

y in

suffi

cien

cy: 2

4-

Ost

eoar

thrit

is: 3

2-

Anx

iety

or d

epre

ssio

n: 3

4-

Hyp

erlip

idem

ia: 2

0-

GER

D: 2

1-

Urin

ary

inco

ntin

ence

: 3-

All

co-m

orbi

ditie

s: 7

0

Intra

-ope

rativ

e m

orta

lity:

0

Dea

ths (

betw

een

30 a

nd

180

days

pos

t-ope

rativ

ely)

: 3

Con

vers

ions

: 10

(12.

4%)

Num

ber o

f co-

mor

bidi

ties

(per

pat

ient

ave

rage

): 3

vs 1

fo

r pat

ient

s < 5

5 ye

ars

Mea

n bl

ood

loss

: 132

cc

Aver

age

oper

atin

g tim

e:

124

min

utes

Impr

ovem

ent o

r res

olut

ion:

Dia

bete

s: 9

2% (4

7)

Hyp

erte

nsio

n: 7

8% (4

0)

Cha

nges

in n

umbe

r of p

resc

riptio

ns (R

x), c

osts

and

sa

ving

s (U

S$) p

er p

atie

nt p

er m

onth

:

Bef

ore

Afte

r6

mos

1 yr

2 yr

s*N

o. o

f Rx

324

112

113

38N

o. o

f pa

tient

s4.

21.

41.

41.

5

Cos

t36

911

911

910

5Sa

ving

s25

025

026

4R

educ

tion

68%

68%

72%

Ann

ualiz

ed c

osts

and

savi

ngs (

US$

) per

pr

escr

iptio

n:In

terv

alC

osts

Savi

ngs

Pre-

op34

5,05

6.40

6 m

os p

ost-o

p11

1,47

7.60

233,

578.

801

year

pos

t-op

111,

057.

1223

3,98

1.28

2 ye

ars p

ost-o

p97

,961

.76

247,

150.

80

Tota

l cos

ts o

f car

e: $

US6

31,0

00 (b

ased

on

aver

age

cost

of $

US8

,090

per

inte

rval

)

Num

ber o

f pre

scrip

tions

: dat

a w

ere

obta

ined

from

pat

ient

s an

d ch

ecke

d ag

ains

t med

ical

re

cord

s.

Pres

crip

tion

cost

s: c

ost o

f a

30-d

ay su

pply

of e

ach

drug

w

as o

btai

ned

from

thre

e re

tail

sour

ces a

nd a

vera

ged.

Aver

age

savi

ngs:

diff

eren

ce

betw

een

the

aver

age

cost

at e

ach

stud

y in

terv

al a

nd th

e av

erag

e pr

e-op

erat

ive

cost

.

Cos

t per

stud

y in

terv

al: a

vera

ge

cost

of s

urge

ry a

nd m

edic

al

fees

, con

sulta

tions

and

hos

pita

l se

rvic

es o

btai

ned

from

the

data

bank

of a

sing

le in

sure

r (in

surin

g 75

% o

f the

pat

ient

s in

the

stud

y da

taba

se).

* 25

of t

he in

itial

78

patie

nts

98

APPENDIX I METROPOLITAN LIFE INSURANCE COMPANY TABLES

(Prepared from the 1979 Build Study)TABLE I-1

Metropolitan Life Insurance Company table (women with medium frames)

Height (cm) Weight (kg) Height (cm) Weight (kg)

148 49.6–55.1 166 58.1–64.5149 50.0–55.5 167 58.7–65.0150 50.3–55.9 168 59.2–65.5151 50.7–56.4 169 59.7–66.1152 51.1–57.0 170 60.2–66.6153 51.5–57.5 171 60.7–67.1154 51.9–58.0 172 61.3–67.6155 52.2–58.6 173 61.8–68.2156 52.7–59.1 174 62.3–68.7157 53.2–59.6 175 62.8–69.2158 53.8–60.2 176 63.4–69.8159 54.3–60.7 177 64.0–70.4160 54.9–61.2 178 64.5–70.9161 55.4–61.7 179 65.1–71.4162 55.9–62.3 180 65.6–71.9163 56.4–62.8 181 66.1–72.5164 57.0–63.4 182 66.6–73.0165 57.5–63.9 183 67.1–73.5

TABLE I-2

Metropolitan Life Insurance Company table (men with medium frames)

Height (cm)

158159 160 161 162 163164 165 166 167 168 169 170 171 172 173 174 175

Weight (kg)

5 9 . 6 – 6 4 . 2 5 9 . 9 – 6 4 . 5 6 0 . 3 – 6 4 . 9 6 0 . 6 – 6 5 . 2 6 1 . 0 – 6 5 . 6 6 1 . 3 – 6 6 . 0 6 1 . 7 – 6 6 . 5 6 2 . 1 – 6 7 . 0 6 2 . 4 – 6 7 . 6 6 2 . 8 – 6 8 . 2 6 3 . 2 – 6 8 . 7 6 3 . 8 – 6 9 . 3 6 4 . 3 – 6 9 . 8 6 4 . 8 – 7 0 . 3 6 5 . 4 – 7 0 . 8 6 5 . 9 – 7 1 . 4 6 6 . 4 – 7 2 . 4 66.9–72.4

Height (cm)

176 177 178 179 180 181 182 183 184 185 186187188189190191192193

Weight (kg)

67.5–73.0 68.1–73.5 68.6–74.0 69.2–74.6 69.7–75.1 70.2–75.8 70.7–76.5 71.3–77.2 71.8–77.9 72.4–78.6 73.0–79.3 73.7–80.0 74.4–80.7 74.9–81.5 75.4–82.2 76.1–83.0 76.8–83.9 77.6–84.8

* For people aged 25 to 69, these fi gures assume that women are wearing shoes with 2.5-cm heels and outdoor clothing weighing 1.4 kg and that men are wearing outdoor clothing weighing 2.3 kg.

99

APPENDIX J BAROS SCORING KEY(Bariatric Analysis and Reporting Outcome System)

Source: Oria and Moorehead, 1998.

WEIGHT LOSS

% OF EXCESS MEDICAL CONDITIONS QUALITY OF LIFE QUESTIONNAIRE

Weight gain Aggravated 1. SELF-ESTEEM

(–1) (–1)

–1.0 –0.50 0 +0.50 +1 0–24 Unchanged 2. PHYSICAL

(0) (0)

–0.50 –0.25 0 +0.25 +0.50 25–49 Improved 3. SOCIAL

(1) (1)

–0.50 –0.25 0 +0.25 +0.50 50–74 One major resolved 4. LABOUR

(2) Others improved (2)

–0.50 –0.25 0 +0.25 +0.50 5. SEXUAL

75–100 All major resolved (3) Others improved (3)

–0.50 –0.25 0 +0.25 +0.50

Subtotal: Subtotal: Subtotal:

Complications: minor: deduct 0.2 points major: deduct 1 pointRe-operation: deduct 1 point

TOTAL SCORE

Outcome groupsScoring keyFailure 1 point or lessFair > 1 to 3 pointsGood > 3 to 5 pointsVery good > 5 to 7 pointsExcellent > 7 to 9 points

100

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