ueda 2016 bariatric surgery -fawzy el mosalamy
TRANSCRIPT
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Bariatric surgery: options, trends,
and latest innovations
Fawzy El-Messallamy
A Prof. of Internal Medecine Diabetes & Endocrinology
Zagazig University
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Metabolic Surgery
Alteration of the gastrointestinal tract that affects
cellular and molecular signaling leading to a
physiologic improvement inEnergy balance .
Nutrient utilization .
Metabolic disorders.
Kaplan LM, Seeley RJ, Harris JL. Bariatric Surgery and the Road Ahead, Bariatric Times, 9
(9): Supplement C, September 2012. http://bariatrictimes.epubxp.com/i/82655 4
What are parameters of obesity?
1) Body mass index
Normal BMI 20-25
Over weight 25-30
Obese >30
Class I 30-35
Class II 35-40
Class III > 40
BMI = )(m Height
kg/Weight2
Waist circumference
risk Substantial risk
Female 80 cm 88 cm
Male 94 cm 102 cm
Apple-shaped more risk than Pear-shaped
Dramatic increase during last 2 decades
2/3 US individuals are overweight
50% of these are obese
5% morbidly obese
Rapid growth in BMI subgroups ≥ 35 and ≥ 40
Increase in comorbidities
2.5 million deaths per year worldwide from comorbidities
1. National Center for Health Statistics NHANES IV Report2. Flegal KM et al: Prevalence and trends in obesity among US adults 1999-2000. JAMA 2002; 288: 1723-1727
Derived from Center for Disease Control and Prevention website www.cdc.gov
Derived from Center for Disease Control and Prevention website www.cdc.gov
BMI ≥ 35 kg/m²: Risk of death ≈ 2.5 times greater than if BMI of 20-25
kg/m²
BMI ≥ 40 kg/m²: Risk of death 10 times greater
Obesity
2nd leading cause of preventable premature death in US (smoking)
Stroke
Coronary
heart
disease
Cancer (endometrial, breast,
colon)
Diabetes
THE PROBLEMS
20 Years Ago
210 Calories
2.4 ounces
Today
610 Calories
6.9 ounces
How to burn* 400
calories:
Walk 2 hr 20 MinutesLow HDL
Insulin
Resistance
CARDIOMETABOLIC
Syndrome
High LDL
Hypertension
Endothelial Dysfunction
Mortality
Obesity associated conditionsDiabetes
Hypertension
Sleep apnea
Congestive heart failure
Hyperlipidemia
Stroke
Coronary Artery Disease
Osteoarthritis
Gastroesophageal Reflux Disease
Non-alcoholic fatty liver
Psychological disturbances
1. Calle et al. N Eng J Med, 1999; (15)341:1097-105. 2. Ali H, Mokdad AH, et al. JAMA 2004;291:1238-1245.
Relatively ineffective:
Diet with and without support organizations
Pharmaceutical agents
Only long-term options:
Bariatric surgery
Metabolic surgery
1991 National Institute of Health Guidelines
BMI ≥ 40 or ≥ 35 with significant comorbidities
1. North American Association for the Study of Obesity and the National Heart, Lung, and Blood Institute. The Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. Bethesda, Md: National Institutes of Health; 2000. NIH 00-4084.
2. Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA 2004;292: 1724-37.
3. National Institutes of Health Consensus Development Panel. Gastrointestinal surgery for severe obesity. Ann Intern Med. 1991; 115: 956-961
First line of treatment
Calorie restriction
Exercise regimen
Behavior modification
Pharmacotherapy
Average weight loss ≈ 5% to 10% initial body weight at 3 to 6 months
Regain weight after 1 to 2 years
1. Yanovski SZ, Yanovski JA. Obesity. N Engl J Med 2002;346: 591-602
Consensus Guidelines 2003
Surgical therapy should be considered for individuals who: Have a BMI of greater than 40 kg/m²
OR
Have a BMI greater than 35 kg/m² with significant comorbidities
AND
Can show that dietary attempts at weight control have been ineffective
Derived from American Society of Bariatric Surgery website: www.asbs.org
Bariatric Surgery
Diet
Exercise
Behavior Modification
“Postoperative care, nutritional counseling, and surveillance should continue for an indefinitely long period.”
Obesity related to a metabolic or endocrine disorder
History of substance abuse or major psychiatric problem
Surgery contraindicated or high risk
Women who want to become pregnant within the next 18 months
Period or Decade Incidence of surgery Reason for change
Late 1970’s Early 1980’s
25,000 procedures per year
Innovative procedures• gastroplasty• loop GBP• jejuno-ileal bypass
Late 1980’s1990’s
5,000 procedures per year
Multifactorial:• High M&M• Ineffective long-term• Perceived failure• Surgeon experience
2000’s80,000 to 110,000 procedures per year
Multifactorial:• Laparoscopy• Long-term data• Centers of Excellence
1. National Hospital Discharge Survey Public-use data file and documentation. Multi-year data CD-ROM. National Center for Health Statistics, 1979-1996.
2. Nguyen et al. Accelerated growth of bariatric surgery with the introduction of minimally invasive surgery. Arch Surg 2005; 140: 1198-202.3. Griffen et al. The decline and fall of the jejunoileal bypass. Surg Gynecol Obstet 1983; 157: 301-8.4. Shirmer et al. Bariatric Surgery Training: Getting Your Ticket Punched. J Gastrointest Surg 2007;11: 807-12.
Study Type and size Effect on weightEffect on
comorbidities
Buchwald et al.Meta-analysisn = 22,094 pts
Mean excess weight loss: 61%
Resolution of: •Diabetes: 70%• HTN: 62%• Sleep apnea: 86%
Swedish Obese Subject trial (SOS)
Prospective matched cohortn = 4,047 pts
At 10 years:• Med: 1.6% gain• Surg: 16% loss
Improved by surg:• Diabetes• Lipid profile• HTN• Hyperuricemia
1. Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA 2004;292: 1724-37.
2. SjostromL, Lindros AK, Peltonem M, Torgerson J, Bouchard C, Carlsson B, et al. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med 2004;351: 2683-93.
Jejuno-ileal bypass
70% excess weight loss
Reduced caloric intake
Malabsorption
Dehydration
Acidosis
Electrolyte abnormalities
Liver failure
Bacterial overgrowth
1. Griffen WO Jr, Bivins BA, Bell RM. The decline and fall of the jejunoileal bypass. Surg Gynecol Obstet 1983; 157: 301-8.
Loop gastric bypass
Reduced capacitance
Aversive eating
Dumping syndrome
Alkaline reflux gastritis
Esophagitis
Horizontal gastroplasty
“Gastric stapling”
1970’s
Regained weight
Many pts left
GERD
Obesity
May seek re-operation for correction anatomy
1. Salmon PA. Salvage of failed horizontal gastroplasty by the addition of a distal gastric bypass. Obes Surg 1993;3:45-51.
“Gold Standard”
80% of bariatric proc.
Lap vs Open
Restrictive and Malabsorptive:
Reduced calorie intake
Macronutrient malabsorption
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Controversy Study Type and size Results
Defunctionalizedjejunum limb lenght
Brolin et al.
Prospective (n = 45)22 pts: 75 cm length23 pts: 150 cm lengthMean f/u: 43 ± 17 m
Mean exc. wght loss:• 50% for short limb• 64% for long limb• No difference in complications
Internal hernia • Lap vs Open• Roux limb position• Mesocolic closure
Higa et al.Retrospective (n = 2000)
Hernia site:• mesocolic: 67%• Jejunal: 21%• Petersen: 7.5%
Leaks or bleeding:• Drain placement• UGI series
Dallal et al.
Prospective(n = 352)
No drains or UGI
Small complication rate recognized from tachycardia
1. Brolin RE. Long limb Roux en Y gastric bypass revisited. Surg Clin North Am 2005;85:807-17, vii.2. Higa KD, Ho T, Boone KB. Internal hernias after laparoscopic Roux-en-Y gastric bypass: Incidence, treatment and prevention.
Obes Surg 2003;13(3):350–4.3. Dallal RM, et al. Back to basics – clinical diagnosis in bariatric surgery. Routine drains and upper GI series are unnecessary. Surg
Endosc 2007;21:2268-71. Epub 2007 May 5.
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Popular in 80’s and 90’s
Less common than RYGB
Purely restrictive
Rapid sense of satiety
Reduced calorie intake
Pouch creation
Hole through anterior and posterior wall
Staple line to angle of His
Nondistensible band around distal neo-pouch
Randomized trials:
VBG vs RYGB
Better weight loss w/ RYGB
Similar operative risks
Replaced by Adjustable gastric band
Similar outcomes
Technically easier
1. Hall JC, Watts JM, O’Brien PE, Dunstan RE, Walsh JF, Slavotinek AH, et al. Gastric surgery for morbid obesity. The Adelaide Study. Ann Surg 1990;211:419-27.
2. Howard L, Malone M, Michalek A, Carter J, Alger S, Van Woert J. Gastric bypass and vertical banded gastroplasty – a prospective randomized comparison and 5 – year follow-up. Obes Surg 1996;5:55-60.
Dr. Cadiere 1992
Technically simple
Purely restrictive
Decrease hunger
Early satiety
Food aversion
Adjustment to stoma diameter
Scopinaro (Italy)
Significant weight loss 75% excess weight loss
Maintained > 20 yrs
Super-morbid obesity BMI ≥ 60 kg/m²
Restrictive
Malabsorptive
Decreased hunger Hormonal changes: distal delivery of nutrients
1. Marinary GM, Murelli F, Camerini G, Papadia F, Carlini F, Stabilini C, et al. A 15 year evaluation of biliopancreatic diversion according to the Bariatric Analysis Reporting Outcome (BAROS). Obes Surg 2004;14:325-8.
2. Scopinaro N, Gianetta E, Adami GF, Friedman D, Traverso E, Marinari GM, et al. Biliopancreatic diversion for obesity at eighteenyears. Surgery 1996;119:261-8.
Partial gastrectomy
200 – 500 ml gastric pouch
Ileal transection
250 cm above ileocecal valve
Gastro-ileal anastomosis
End-to-side ileoileostomy
50 cm proximal to ICV
Alimentary channel = 200 cm
Common channel = 50 cm
Induced weight loss: Improves comorbidities before 2nd operation
Silechia et al: 41 superobese pts
2nd stage operation
60% resolved comorbidities
24% resoved prior to 2nd procedure
Avoids complications: Anastomotic leak
Stricture
Internal hernia1. Silechia G, et al. Effectiveness of laparoscopic sleeve gatrectomy (first stage of biliopancreatic diversion with duodenal switch) on
comorbidities in super obese high-risk patients. Obes Surg 2006;16:1138-44.2. Frezza EE, et al. Laparoscopic vertical sleeve gastrectomy for morbid obestiy. The future procedure of choice? Surg Today 2007;37:275-81.
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OPEN ↑ post op pain
Longer hospitalizations
↑ wound complications Infection
Hernias
Seromas
Return to work in 4-8 weeks
LAPAROSCOPIC ↓ post op pain
Early mobility
↓ Wound complications
2-3 day hospital stay
Return to work in 1-3 weeks
1. Nguyen NT, et al. Accelerated growth of bariatric surgery with the introduction of minimally invasive surgery. Arch Surg 2005;140:1198-202.
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VBG vs LAGB
Similar % excess weight loss:
38% at 12 months
45% at 24 months
54% at 36 months
European trials: LAGB up to 70%
1. Ren CJ, Horgan S, Ponce J. US experience with the LAP-BAND system. Am J Surg 2002;184(6B):46S-50S.2. Belachew M, Belva PH, Desaive C. Long term results of laparoscopic adjustable gastric banding for the treatment of morbid
obesity. Obes Surg 2002;12:564-8.
Laparoscopic Adjustable Gastric Banding LAGB Vertical Banded Gastroplasty VBG
RYGB vs LAGB
Recent Italian randomized study
5 year follow-up
RYGB: significantly lower weight and BMI
BPD or Duodenal switch
Greater weight loss in super-obese
70% excess weight loss up to 25 yrs post op
Minimal rebound at 10 yrs post op
Laparoscopic Adjustable Gastric Banding LAGB Vertical Banded Gastroplasty VBG Biliopancreatic Diversion BPD
1. Angrisani L, et al. Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 5 year results of prospective randomized trial Surg Obes Relat Dis 2007;3:127-32, discussion 132-2.2. Prachand VN, et al. Duodenal switch provides superior weight loss in the super-obese (BMI > 50) compared with gastric bypass. Ann Surg 2006;244:611-19.3. De Maria EJ, Schauer P, Patterson E, Nguyen NT, Jacob BP, Inabnet WB, et al. The optimal surgical management of the super-obese patient: the debate. Presented at the annual meeting of the Society of
American Gastroenterology and Endoscopic Surgeons, Hollywood, Florida, USA, April 13-16, 2005. Surg Innov 2005;12:107-21.
Surgical patients vs Control subjects
Recent studies: Mortality decreased by 40% in surgical group
Long-term death lower in surgical group
Multiple studies: Weight loss and improved comorbidities
30% to 85% Reduced Mortality
compared to nonsurgical care
N=1041 year post op
NumberPre-op % Worse
% No change
% Improved
% Resolved
Osteoarthritis 64 2 10 47 41
Hypercholesterolemia 62 0 4 33 63
GERD 58 0 4 24 72
Hypertension 57 0 12 18 70
Sleep Apnea 44 2 5 19 74
Hypertriglyceridemia 43 0 14 29 57
Peripheral Edema 31 0 4 55 41
Stress Incontinence 18 6 11 39 44
Asthma 18 6 12 69 13
Diabetes 18 0 0 18 82
Average 1.6% 7.8% 35.1% 55.7%
90.8% Improved or Resolved
Schauer, et al. Ann Surg 2000 Oct;232(4):515-29
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Rapid decrease in serum blood sugar
Decrease in medication requirements
66% to 75% complete resolution
Increased insulin sensitivity
Inhibits progression of disease
Swedish Obese Subject Trial:
Reduced relative risk by factor of 30 compared to medically treated population
1. Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA 2004;292: 1724-37.
2. Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, et al. Who would have thought it ? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg 1995;22:339-50, discussion 350-2.
3. SjostromL, Lindros AK, Peltonem M, Torgerson J, Bouchard C, Carlsson B, et al. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med 2004;351: 2683-93.
50% complete resolution
25% reduced medications
Swedish Obese Subject Trial: 2 years post op
Decreased relative risk of new onset HTN = 10
Time interval for resolution not cleared
1. SjostromL, Lindros AK, Peltonem M, Torgerson J, Bouchard C, Carlsson B, et al. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med 2004;351: 2683-93.
70% prevalence in gastric bypass pts
80% improvement
No more CPAP
Decreased pCO2
Increased pO2
1. Dixon JB, et al. Predicting sleep apnea and excessive day sleepiness in the severity obese: indicators for polysomnography. Chest 2003;123:1134-41.
2. Sugerman HJ, et al. Gastric surgery for respiratory insufficiency of obestiy. Chest 1986;90:81-6.
Non-alcoholic fatty liver:
Resolution of steatosis
Improved liver contour
Osteoarthritis:
50% reduced medication intake
Decreased joint stress from weight loss
Delayed operative joint intervention
Depression:
High prevalence in obese
Decreased medication use1. Clark JM, et al. Roux-en-Y gastric bypass improves liver histology in patients with non-alcoholic fatty liver disease. Obes Res
2005;13:1180-62. Abu-Abeid S, et al. The influence of sugically-induced weight loss on the knee joint. Obes Surg 2005;15:1437-42.3. Sarwer DB, et al. Psychiatric diagnoses and psychiatric treatment among bariatric surgery candidates. Obes Surg 2004;14:1148-56.
Surgical
Technical errors
Errors in judgment
Type of procedure
1. Mason EE, et al. Causes of 30-day bariatric surgery mortality: with emphasis on bypass obstruction. Obes Surg 2005;71:9-14.
Metabolical
Malabsorption
Nutrients
Vitamins
CarbohydrateLipid
ProteinsCa²+Fe ²+
B 12
A, D, E, K
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A growing consensus favors bariatric surgery
page 57
“Bariatric surgery should be considered for adults with BMI ≥
35 kg/m2 and type 2 diabetes, especially if the diabetes is
difficult to control with lifestyle and pharmacologic therapy.”
– American Diabetes Association (2009)
“When indicated, surgical intervention leads to significant
improvements in decreasing excess weight and co-
morbidities that can be maintained over time.”
– American Heart Association (2011)
“Bariatric surgery is an appropriate treatment for people with
type 2 diabetes and obesity not achieving recommended
treatment targets with medical therapies”
– International Diabetes Federation (2011)
“The beneficial effect of surgery on reversal of existing DM
and prevention of its development has been confirmed in a
number of studies”
– American Association of Clinical Endocrinologists (2011)
Sources: American Diabetes Association. Standards of medical care in diabetes – 2009. Diabetes Care 2009; 32(S1):S13-S61,
Poirier P, Cornier M-A, Mazzone T et al. Bariatric surgery and cardiovascular risk factors: A scientific statement from the American Heart Association. Circulation 2011; 123:00-00.
International Diabetes Federation. Bariatric surgical and procedural interventions in the treatment of obese patients with type 2 diabetes. 2011.
Handelsman Y, Mechanick JI, Blone L et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for developing a diabetes mellitus comprehensive plan. Endocr Prac 2011; 17(Suppl 2).
A growing consensus favors bariatric surgery
“The Endocrine Society recommends that practitioners
consider several factors in recommending surgery for
their obese patients with type 2 diabetes, including
patient’s BMI and age, the number of years of diabetes and
the assessment of the (patient’s) ability to comply with the
long-term lifestyle changes that are required to maximize
success of surgery and minimize complications.”
“… remission of diabetes, even if temporary, will still
lead to a reduction in the progression to secondary
complications of diabetes (such as retinopathy,
neuropathy and nephropathy), which would be an important
outcome of … surgery.”
– The Endocrine Society (March 2012)
page 58
Source: The Endocrine Society, Evaluating the Benefits of Treating Type 2 Diabetes with Bariatric Surgery, March 30, 2012.
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60This article was published on March 31, 2014, at NEJM.org.
In short-term randomized trials (duration, 1 to 2 years), bariatric surgery has been associated with improvement in type 2 diabetes mellitus.
Assessed outcomes 3 years after the randomization of 150 obese patients with uncontrolled type 2 diabetes :
1. Intensive medical therapy alone.
2. Intensive medical therapy plus Roux-en-Y gastric bypass.
3. Intensive medical therapy plus sleeve gastrectomy.
The primary end point was a glycated hemoglobin level of 6.0% or less.
At 3 years, the criterion for the primary end point was met by:
1. 5% of the patients in the medical-therapy group.
2. 38% of those in the gastric-bypass group (P<0.001)
3. 24% of those in the sleeve-gastrectomy group (P = 0.01).
The use of glucose-lowering medications, including insulin, was lower in the surgical groups than in the medical-therapy group
Reductions in weight from baseline, with reductions of
1. 24.5±9.1% in the gastric-bypass group.
2. 21.1±8.9% in the sleeve-gastrectomy group.
3. 4.2±8.3% in the medical-therapy group (P<0.001 for both comparisons).
Quality-of-life measures were significantly better in the two surgical groups than in the medical-therapy group.
There were no major late surgical complications.
Among obese patients with uncontrolled type 2 diabetes, 3 years of intensive medical therapy plus bariatric surgery resulted in glycemic control in significantly more patients than did medical therapy alone.
Secondary end points, including body weight, use of glucose-lowering medications, and quality of life, also showed favorable results at 3 years in the surgical groups, as compared with the group receiving medical therapy alone.
(Funded by Ethicon and others; STAMPEDE ClinicalTrials.gov number, NCT00432809.)
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Significant improvement in the albumin-to-creatinine ratio with surgery as compared with medical therapy.
The incidence of Nephropathy (defined as a doubling of the serum creatinine level, >20% reduction in the estimated glomerular filtration rate, new macro- albuminuria, or the need for renal-replacement therapy) was increased in the surgical groups, particularly in the gastric-bypass group.
Gastric bypass surgery is associated with : Long -term increase in urinary oxalate excreation .
Risk of urolithiasis.
Increased oxalate absorption, probably due to fat malab-
sorption and subsequent reductions in the intra- luminal free
calcium concentration,may provide one mechanism for renal
injury after gastric bypass surgery.
The devastating consequences of oxalate
nephropathy after bypass surgery in a case
series of 11 patients.
Although bariatric surgery represents a
valuable treatment to combat the epidemic of
obesity and its complications, unintended
consequences of this gross distortion of gut
physiology should not be overlooked
We have some concerns about the conduct and interpretation of this study
First: Medical- therapy group did receive intensive glucose-lowering therapy. After 3 years, the mean (±SD) glycatedhemoglobin level was 8.4±2.2%, the number of glucose-lowering drugs was 2.6±1.1, and only 55% of patients used insulin. Hence, although not reaching protocol targets, medical therapy was not intensified according to published guide- lines. Nearly half the patients did not use insulin despite ample evidence that it can improve glycemic control.
Second : levels of low-density lipoprotein cholesterol and blood pressure were not significantly reduced in the surgical groups, findings that are at variance with those in previous reports from us and others
Despite convincing data, the question remains whether surgery can provide the solution to the obesity epidemic.
In the past 20 years, rates of severe obesity tripled in the United States.
According to current projections, 50% of the adult population will be obese by 2030. Thus, do we need more bariatric surgery?
At an estimated cost of about $25,000 per surgery,operating on only severely obese persons would consume 15 to 20% of annual health care expenditures.
Expenditures do not stop with the surgical procedure, as prior studies have shown persistently high health care utilization and costs for at least 6 years after surgery.
Truly overcoming this epidemic will require different strategies that have proved affordable and effective in dealing with the devastating effects of unhealthy food
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Bariatric surgery is an effective treatment for diabetes
and impaired glucose tolerance in patients with a body
mass index of at least 35 but less than 40 kg/m2 who are
followed up to 2 years.
Weight-loss and glucose-control outcomes achieve
greater improvement than typically seen with behavioral
interventions (e.g., diet, exercise).
Head-to-head comparisons are needed to determine
comparative effectiveness among surgical interventions.
Maglione MA, Gibbons MM, Livhits M, et al. AHRQ Comparative Effectiveness Review No. 82.Available at www.effectivehealthcare.ahrq.gov/weight-loss-surgery.cfm.
The rates of short-term adverse effects (cardiovascular, respiratory, gastrointestinal, and metabolic) were low.
Reported complications of laparoscopic adjustable gastric banding include band slippage, leakage, and pouch dilation, and those reported for Roux-en-Y gastric bypass include stricture, ulcers, and rarely hemorrhage.
While not discussed in the review, it has been suggested that weight regain and recurrence of diabetes might be observed after bariatric surgery.
Maglione MA, Gibbons MM, Livhits M, et al. AHRQ Comparative Effectiveness Review No. 82.Available at www.effectivehealthcare.ahrq.gov/weight-loss-surgery.cfm.
Despite promising short-term outcomes, very few studies of this target population have follow up durations greater than 2 years.
The long-term effects of bariatric surgical procedures on major clinical endpoints in this patient population with a lower body mass index are not known.
Studies comparing surgical intervention to comprehensive care and behavioral interventions to each other are also needed to determine the relative effectiveness of these strategies in the long term.
Maglione MA, Gibbons MM, Livhits M, et al. AHRQ Comparative Effectiveness Review No. 82.Available at www.effectivehealthcare.ahrq.gov/weight-loss-surgery.cfm.
There is a scarcity of high-quality studies for patients with a body mass index of 30.0 to 34.9 kg/m2 and metabolic comorbidities.
Very few studies had long-term follow up (more than 2 years).
The effectiveness of bariatric surgery in preventing the clinical consequences of diabetes and its impact on major clinical endpoints such as cardiovascular mortality or morbidity have not been studied.
Of the 54 studies included in the comparative effectiveness review, a very limited number were conducted in the United States, making applicability of findings from studies conducted outside the United States to American patients unclear.
Maglione MA, Gibbons MM, Livhits M, et al. AHRQ Comparative Effectiveness Review No. 82. Available www.effectivehealthcare.ahrq.gov/weight-loss-surgery.cfm.
Quality-of-life and psychological outcomes after surgery were rarely reported.
Most studies were not designed to assess adverse events and reflected events reported by the surgeon or the surgical team. The rates of adverse events in these studies may, therefore, be lower than rates experienced in the wider community.
For all surgical procedures, there is concern that published studies usually come from academic medical centers. Outcomes for patients in these studies may not reflect the outcomes achieved in the wider community.
Maglione MA, Gibbons MM, Livhits M, et al. AHRQ Comparative Effectiveness Review No. 82.Available at www.effectivehealthcare.ahrq.gov/weight-loss-surgery.cfm.
The possible benefits of bariatric surgery for patients with a body mass index between 30.0 and 34.9 kg/m2 and with diabetes or IGT
The possibility that the patient could be referred to a surgeon who would discuss the different types of bariatric surgery recommended for the patient
The possible adverse effects of bariatric surgery
Whether or not the specific bariatric surgery recommended for the patient would be covered by the patient's insurance and how that would impact the patient's decision making
Lifestyle changes that are necessary to fully benefit from bariatric surgery
Nonsurgical treatment options for diabetes and other metabolic conditions
The expected course of the patient's diabetes with continued nonsurgical therapy
Maglione MA, Gibbons MM, Livhits M, et al. AHRQ Comparative Effectiveness Review No. 82.Available at www.effectivehealthcare.ahrq.gov/weight-loss-surgery.cfm.
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