bowel prep talaga

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R E S E A R C H • R E C H E R C H E

Preoperative bowel preparation for patients

undergoing elective colorectal surgery a clinical

practice guideline endorsed by the C anadian

S ociety of C olon and R ectal S urgeons

Cagia E skiciog lu, MD , MSc*' ''

Shaw n S. Forbes, MD , MSc ^

Darlene S. Fenech, MD, MSc *

Robin S. McLeod, MD*^^

For the Best Practice in General

Surgery Commit tee

From the *Department of S urgery,

University of Toronto, the tZa ne Cohen

Digestive Diseases Clinical Research

Centre and Mount Sinai Hospital, the

tSunnybrook Health Sciences Centre

and the §Department of Health Policy,

Management and Evaluation, University

of Toronto, and the Samuel Lunenfeld

Research Ins titute, Toron to, Ont.

Accepted for publication

May 19, 2009

C orrespondence to

Dr. R.S. McLeod

Mount Sinai Hospital, Rm. 449

600 University Ave.

Toronto ON M5G 1X5

[email protected]

ackground Despite evidence that mechanical bowel preparation (MBP) does not

reduce the rate of postoperative complications, many surgeons still use MBP before

surgery. We sought to appraise and synthesize the available evidence regarding preop-

erative bowel preparation in patients undergoing elective colorectal surgery.

Methods

We searched MEDLINE, EMBASE and Cochrane Databases to identify

randomized controlled trials (RCTs) comparing padents who received a bowel prepa-

ration with those who did not. Two authors reviewed the abstracts to identify articles

for critical appraisal. We used the methods of the United States Preventive Services

Task Force to grade study quality and level of evidence, as well as formulate the final

recommendations. Outcomes assessed included postoperat ive infect ious complica-

tions, such as anastomotic dehiscence and superficial surgical site infecdons.

Resu lt s Our review idendfied 14 RCTs and 8 meta-analyses. Based on the quality

and content of these original manuscripts, we formulated 6 recommendadons for vari-

ous aspects of bowel preparadon in padents undergoing elecdve colorectal surgery.

Conc lus ion Taking into account the lack of difference in postoperadve infecdous

complicadon rates when MBP is omitted and the adverse effects of MBP, we believe

that, based on the literature, MBP before surgery should be omitted.

Contex t e : En dépit de données probantes indiquant que la préparadon mécanique

de l intesdn (PMI) ne réduit pas le taux de comp licadons postopératoires, beauco up

de chirurgiens utilisent toujours la PM I avant l intervention. No us avons cherché à

évaluer et résumer les données probantes disponibles sur la préparadon préopératoire

de l intesdn chez les pade nts qui subissent une ch irurgie colorectale élecdve.

Méthod e s

: Nous avons effectué une recherche dans MEDLINE, EMBASE et les

bases de données Cochrane pour repérer les essais contrôlés randomisés (ECR) où

l on a comparé les patients qui ont reçu une prépara don de l intesdn à ceux qui n en

ont pas reçu. Deux auteurs ont analysé les résumés pour repérer les árdeles à soumet-

tre à une évaluadon critique. Nous avons udlisé les métho des du Gro upe de travail sur

les services de prévendon des États-Unis (United States Prevendve Services Task

Force p our évaluer la qualité de l étude et le niveau des éléments probants, et po ur

fomiuler des recommandations finales. Les résultats évalués ont inclus les complica-

dons infectieuses postopé ratoires com me la déhiscence de l anastomose et les infec-

dons superficielles du site chirurgical.

Résu l t a t s

: Notre étude a permis de repérer 14 ECR et 8 méta-analyses. Compte

tenu de la qualité et du contenu de ces manuscrits originaux, nous avons formulé

6 recom man dations portant sur divers aspects de la préparation de l intestin chez les

patients qui subissent une chirurgie colorectale élective.

Conc lus ion

: Com m e il n y avait pas de différence au niveau des taux de co mplica -

tions infecdeuses postopératoires lorsque la PMI est omise et compte tenu des effets

indésirables de la PM I, nous somm es d avis, en nous basant sur les publicadons, qu il

faudrait abandonner la PMI avant les intervendons chirurgicales.

echanical bowel preparation (MBP) before elective colorectal

surgery has been the standard in surgical pracdce for over a century.

It is believed that MBP decreases intraluminal fecal mass and pre-



R H R H

decrease in fecal load and bacterial contents reduces the

rates of infectious postoperative complications, such as

anastomotic dehiscence. These theories, however, have

been based largely on clinical experience and expert opin-

ion.'- The first study to challenge the need for MBP was

published in 1972.' Since then, there has been moundng

level-I evidence indicadng that MBP does not reduce the

rate of postoperadve complicadons, including anastomodc

failure.'^'

Despite this evidence, a survey of colorectal surgeons in

the United States published in 2003 revealed that 99% of

the surgeons surveyed used MBP before surgery. In 2006,

a muldnadonal audit of 1082 padents from 295 hospitals in

Europe and the United States revealed that 86%-97%

(mean 94%) of patients received preoperative MBP.'

These surveys indicate that a large gap exists between the

evidence surrounding the use of MBP and surgeon prac-

dces. It is unclear why surgeons have no t changed pracdce

to parallel the best evidence, since prescribing MBP also

results in unnecessary costs (i.e., preadmission of padents,

nursing care) as well as increased risks and discomfort for

padents. Communicadon with local experts has indicated

that the major hurdles may include lack of w reness of the

evidence and, simply, reluctance to change.

ecommend tions

1.

There ¡s good evidence for the omission o f mechanical

bowel preparation in the preoperative management of

patients undergoing elective open right-sided colorectal

surgery.

Grade A recommendation)

2.

There is good evidence for the omission of mechanical

bowel preparation in the preoperative management of

patients undergoing elective open left-sided colorectal

surgery.

Grade A recommendation)

3. There is insufficient evidence to support or refute the

omission of mechanical bowel preparation in the pre-

operative management of patients undergoing elective

low anterior resections with or without diverting

ileostomy.

Grade I recommendation)


omission of mechanical bowel preparation in the pre-

operative management of patients undergoing elective

laparoscopic colorectal surgery.

Grade I recommend-

ation)

5. There is fair evidence to recommend normal diet on the

day prior to surgery in the preoperative management of

patients undergoing elective colorectal surgery.

Grade

B recommendation)


use of enemas in the preoperative management of

patients undergoing elective colorectal surgery.

Grade

I recommendation)

There is some evidence that guidelines can be used a

knowledge transladon strategy to target physician awa

ness.' Th is guideline has been prepared for general s

geons and general surgery residents who are involved

the preoperadve management of padents undergoing el

tive colorectal surgery. The question addressed by t

guideline is this: In padents undergoing elecdve colorec

surgery, do MBP, dietary modificadons and enemas redu

the risk of infecdous complicadons, such as superficial s

gical site infecdons (SSIs) and anastom odc leaks?

METHODS

efinitions

Bowel preparadon before elecdve colorectal surgery c

include a variety or combination of interventions. For t

purposes of this guideline, MBP refers to the use of

oral laxative solution used to cleanse the colon of fec

contents (e.g., polyethylene glycol, sodium phospha

sodium picosulphate, magnesium citrate). Preoperati

dietary modifications and the use of enemas are al

addressed as separate components of bowel preparatio

The use of normal diet refers to allowing padents a re

ular, unrestricted diet on the day before surgery. This c

be replaced with a clear-fiuid diet, which restricts patie

from eating solid food. An enema is the administration

liquid in the rectum to evacuate stool.

Literature review

We performed 2 searches with the assistance of medi

librarian. The first search identified articles evaluad

postoperative complications in patients who did and d

not receive bowel preparation (including MBP, dieta

restrictions and enemas). The second search identifi

articles describing adverse effects related to the use

MB P. These search strategies complete w ith medical su

ject headings are outlined in Tab le 1.

We searched MEDLINE, EMBASE and Cochra

databases to identify relevant articles published betwe

January 1950 and February 2009 that compared ad

patients who received bowel preparation or no bow

preparadon and reported postoperadve infecdous comp

cadons as an outcome (search 1). The search was limited

randomized controlled trials (RCTs) involving adu

human participants using the sensitivity strategy

Robinson and Dickersin. W e excluded nonrandomiz

controlled trials and studies including padents undergoi

emergency colorectal surgery.

We also searched MEDLINE, EMBASE and Cochra

databases to idendfy relevant árdeles pertaining to adver

effects (search 2). T'he search strategy was not limited

publieadon type. We manually searched the reference li



R E S E R H

S.S.F.

independently assessed all tide s and abstracts

on selection was resolved by consensus.

uality

ssessment

authors (C.E ., S.S.F.). T he selected manuscripts were

the trial, there was no crossover

he 2 groups, minimum follow-up of 80 was

eported, interventions were clearly defined, well-defined

nd reproducible outcome assessments were used equally

n both groups, outcome assessors were blinded,

ntention-to-treat analysis was employed and appropriate

ttention was given to confounders in the analysis. Stud-

es were deemed to be of poor quality if they had any one

f the following: gross differences between the interven-

tion and control groups at the start of the study, greater

than 10 crossover between the 2 group s, substantial

(> 20 ) loss to follow-up, lack of

power calculation, or

interventions that were not clearly defined. Studies with

minor methodological flaws received a fair rating. Meta-

analyses received a good rating if they were published

within the last 3 years, included a comprehensive litera-

ture search, duplicated study selection and/or data extrac-

tion, used relevant selection criteria, provided character-

istics of the included studies, documented and used a

quality assessment to formulate conclusions, used statis-

tical methods to combine study findings described (i.e.,

pooled analysis, tests for heterogeneity), assessed the like-

lihood of publication bias and stated confiicts of interest.

ecommendations

After critical appraisal of the methodology and evidence of

the included studies, we made recommendations using the

criteria established by the USPSTF.'^ Outcomes assessed

included anastomotic dehiscence and superficial SSIs.

These outcomes were reviewed for all patients unde rgoing

elective colorectal surgery as well as for the following sub-

groups: patients undergoing low anterior resections with

or without diverting ileostomies and patients undergoing

laparoscopic colorectal surgery. Recommendations are

also made regarding preoperative dietary modifications

and the use of preoperative enemas. Finally, the Canadian

Society of Colon and Rectal Surgeons endorsed this

guidehne. |

Table 1. Search strategy for finding evidence regarding mechanical bowel preparation MBP) in patients undergoing elective

colorectal surgery

Search

MEDLINE/Cochrane

EMBASE

: MBP and 1. (mechanical adj2 bowe l adj2 prepar:).ti.ab. OR exp cathartics/

postoperative OR laxatives/

complications 2. exp Colorectal Neoplasms/ OR exp Colonie

3. Neoplasms/OR exp Rectal Neoplasms/

4.

exp Colorectal Surgery/ or exp Surgery/ OR exp Colorectal

Neoplasms/su or exp Colonie Diseases/su or exp Rectal

Diseases/su or Anastom osis, Surgical/ or Colorectal Surgery

5

AN D

2

A ND

3

6. Robinson Dickersin Sens itivity Strategy

7

4

A ND 6

2: MBP and 1- (mechanical adi2 bowe l adj2 prepar:).ti,ab. OR exp cathartics/

adverse effects OR laxatives/

2. exp Cathartics/ae [Adverse Effectsl OR exp laxatives/ae

3. OR 2

4.

exp Colorectal Neoplasms/OR exp Colonie Neoplasms/ OR

exp Rectal Neoplasms/

5. exp Colorectal Surgery/ or exp Surgery/ OR exp C olorectal

Neoplasms/su or exp Colonie Diseases/su or exp Rectal

Diseases/su or Anastomosis, Surgical/ or Colorectal Surgery/

6 OR 5

3 A ND 4

8. Robinson Dickersin Sens itivity Strategy

9. 7 A ND 8

1. (Bowel adj5 PreparO.mp.

2. exp Intestine Preparation/ OR exp Laxative/

3

AN D 2

4.

exp PELVIS SURGERY/ or exp MAJOR SURGERY/ or exp

MINIMA LLY INVASIVE SURGERY/ or exp LAPAROSCOPIC

SURGERY/ or exp ANUS SURGERY/ or exp COLON

SURGERY/ or exp INTESTINE SURGERY/ or exp

GASTROINTESTINAL SURGERY/ or exp RECTUM SURGERY/

or exp COLORECTAL SURGERY/ or exp ABDOMINAL

SURGERY/ or exp SURGERY/ or exp CANCER SURGERY/ or

exp GENERAL SURGERY/ or exp ELECTIVE SURGERY/

5. exp Intestine Tumor/ OR exp Large Intestine Disease/

6

3

A ND

4

A ND 5

7. exp Postoperative Co mplication

8

6

A ND 7

9. Robinson Dickersin Sensitivity Strategy

10. 8 A ND 9

1. (Bowe l adj5 Prepar:).mp.

2.

exp Intestine Preparation/ OR exp Laxative/

3.

AN D 2

4.

exp Adverse Drug Reaction

5 3 AND 4

6. exp Intestine Tumor/ OR exp Large Intestine Disease/

7 5 A ND 6

8. Robinson Dickersin Sensitivity Strategy

9

7

A ND 8



R H R H

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RESE R H

RESULTS

Our search idendfied 14 unique R C T s. *' ' ' One trial'^

was published twice and included only o nce. A nother

trial-' was publisbed as botb an interim and fin l analysis;

we included only

the

final analysis. Tw o trials published

subgroup analyses

as

separate manuscripts

and

were

excluded from furtber review

to

eliminate duplicate

results.

A

summary

of

our quality assessment

of tbe

RCTs is shown in Table

2

We did not assess the quality

of trials'^'' because they were no t publisbed in E nglish.

The literature review identified 8 meta-analyses.'' '

These meta-analyses reported different combinations of

the 14 publisbed RCTs. The largest meta-analysis pub-

lisbed in 2009 combined the results of the 14 RC Ts . The

Cochrane review was publisbed in 2003 and was updated in

2005.-'' We included tbe most current version. The

Cochrane review was also published in another source sep-

arately by the same authors, and we excluded this duplicate

publicadon. A summary of the quality assessment of these

8 m eta-analyses is shown in Table 3.

echanicai bowel preparation

Patients undergo ing open elective colorectal surgery:

anastomo tic leaks

Ml 14 trials compared anastomotic leak rates in patients

receiving MBP and tbose not receiving MBP. Tbe results

for anastomotic leak rates in these trials are summ arized

in Table

4.

Tw o

of

the 14 trials found significant differ-

ences

in

anastomodc leak rates

in

favour

of

the omission

of MBP. ' '

The

other

12

trials found

no

significant

dif-

ferences

in the

anastomodc leak rates. Tw o

of

these trials

were large

and are

described

in

furtber detail below. -'

Tbe main flaw in tbe othe r trials was that they were

underpowered.

An RC T by Contan t and colleagues- published in 2007

was a muldcentre trial where invesdgators from 13 hospi-

tals in the Netherlands randomly assigned 670 padents to

receive MBP and 684 padents to no MBP. Those padents

receiving MBP were prescribed eitber polyetbylene glycol

with bisacodyl

or

a sodium phosphate soludon. There was

no significant difference in anastomodc leaks (difference

0.6%, 95% confidence interval [CI] -1.7% to 2.9%,

p = 0.69).-- This was a fair-quality RCT with one of its

strengths being its large sample size. However, like many

of the RCTs performed on this topic, outcome assessment

was not blinded. Furthermore, the groups were not com-

parable at the beginning of the trial; there was a larger pro-

pordon

of

smokers and padents with inflammatory bowel

disease in tbe M BP group.

In the next R C T by Jung and colleagues,-'' ail Swedish

centres and 1 German colorectal unit pardcipated. In all,

686 padents were randomly assigned

to

receive MBP

and

657 padents to no MBP;' ' 47% of padents in the MBP

group were prescribed a polyethylene glycol preparation

and 48.5% received a sodium phosphate preparation.

There were no significant differences betwe en tbe

2 groups for the primary outcomes of cardiovascular, gen-

eral infecdous and surgical-site complicadons. Specifically,

anastomodc dehiscence was seen in 2.3% of padents in the

MBP group and 2.6% of padents in the no MBP group.

Six padents in each group died

p =

0.94).''

The authors examined the generalizability of the results

and potential selection bias by comparing study partici-

pants

to

those padents who were not enrolled

in

the study

at 3 pardcipadng centres. They found no stadsdcally sig-

nificant differences in the demographics or the outcomes

between tbese

2

groups

of

patients. This study

did not

show a significant difference but was also underpowered

in

that

it

was powered

to

detect a 50% difference

in

compli-

cation rates. However,

it is

unlikely that

the

addidon

of

Table 3. Quality criteria for meta-analyses of mechanical bowel preparation MBP) reporting postoperative complications as an

outcome

Study

Slim et al.^'

Pineda et al

Muller-Stich

et al.»

Guenaga et a l .

Bucher et a l .

Slim et aL '

Wille-Jorgensen

e t a l .

Piateil and Hair

Quality

rating

Fair

Poor

Poor

Fair

Fair

Fair

Fair

Poor

Recent

Yes

Yes

Yes

No

No

No

No

No

Comprehensive

literature search

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

Literature search

not described

Duplicate

selection or

extraction

Yes

No mention

No mention

Yes

Yes

Yes

Yes

No mention

Relevant

selection

criteria

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Characteristics

of included

studies

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Quality used

to

Quality formulate

assessment conclusions

Yes

No

No

Yes

Yes

Yes

Yes

Yes

Yes

No

No assessment

of quality

No

No assessment

of quality

Yes

Yes

Yes

Yes

Yes

Pooled

analysis

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Publication

bias

Yes

No mention

No mention

Yes

Yes

Yes

Yes

No mention

Conflicts

of

interest

stated

No

Yes

No

Yes

No

No

No

No



R H R H

57 patients (for a total of 1400 patients as required by the

reported sample size calculation) would change the conclu-

sion.-' For these reasons, this was not deemed a fatal flaw

and w e gave the trial a fair rating .

Our review of the included meta-analyses revealed that

1 meta-analysis provided

no

pooled data

and

reported only

a descriptive analysis

of the

inc luded s tudies . - '

Of the

remaining 7 m eta-analyses, 4 reported statistically signifi-

cant differences in the pooled results for anastomotic leak-

age.'' -'

Of

these

4

meta-analyses showing

a

difference,

the

largest and most recent was

the

Coch rane review published

in

2005.-'''

T h r e e of the 7 meta-analyses found no significant

difference between the M BP and the no MB P groups .-' '

Of the

3

meta-analyses that reported

no

difference

in

anas-

tomotic leak rates, 1 was the oldest review,' includin g only

3 trials, and th e oth er 2-'' were the mo st recent reviews.

T h e 2 most recent fair-quality meta-analyses were pub-

lished

by

Guenaga

and

colleagues

in

2005'' '

as a

Cochrane

systematic review and by Slim and colleagues in 2009.

The fair-quality review by the former group was an update

of

the

f ir s t Co chr an e rev iew publ i shed

in

2003

and

included

9

trials with

a

total

of

1592 patients.'''

Of

these

padents, 789 were allocated to the MBP group and 80 3 to

th e no MBP group . The main outcome was anastomotic

leakage; other outcomes eva lua ted inc luded morta l i ty,

superficial SSIs, peritonitis

and

reoperation.

The

overall

anastomotic leakage in both grou ps indicated that M BP

was associated with a higher rate of anastomotic leakage

(odds ratio [OR] 2.03, 95%

CI

1.276-3.26, 0.003).-'

T h e a u t h o r s of th i s r ev iew conc lud ed tha t MBP for

patients undergoing elective colorectal surgery has not

proven valuable

and the

procedure should

be

omitted

as it

may increase

the

risk

of

anastomotic dehiscence.

The pri-

mary s t r ength of this meta-analys is was the t h o r o u g h

discussion of the quality and methodo logy of the inclu

articles.

The meta-analysis published by Slim and colleagues

2009 included

14

trials with

a

total

of

4859 patients

provided different results. Th is m eta-analysis included s

stantially more patients because

of the

inclusion

of

t r ia ls by J u n g and c o l l e a g u e s ' ' and C o n t a n t and

leagues,'' which were published after the meta-analysis

Guenaga

and

colleagues.''' T hi s m eta-analysis w as give

fair quality rating because conflicts

of

interest were

reported. In all, 2452 patien ts were ran dom ly assigned

the MBP group and 2407 to the no MBP group . The

comes repor ted were ra tes of anas tom otic leakage

superficial SSIs.

The

poo led results revealed

no

signifi

dif fe rence

in

anas tom ot ic l e akage ra te s be tw een

2 groups widi

a

fairly narrow 95%

CI (OR 1.12,

9 5 %

0.82 4-1.5 32,/? = 0.46). Altho ugh these results diffe

from the results of the Co chrane review, these auth

again concluded that there is no benefit to us ing MBP

patients undergoing elecdve colorectal surgery.

Patients undergoing open elective colorectal surgery: S

All 14 RC Ts in c luded superfic ial SSIs as a n o t h e r e

point, and these results are summarized in Table 5. In

14 trials, there were

no

significant differences

in die

r

of superficial SSIs in die M B P and no MBP groups.-*

O n e of th e 7 meta-analyses reported a significant dif

ence

in

superficial SSIs between

the 2

groups , with

increased rate

of

superficial SSIs

in

padents who recei

M B P ( d i f f e r e n c e 3.4%, 95% CI -1 .6% to 8.4

p = 0.002).' T h e other 6 meta-analyses found no differe

in

the

rates

of

superficial SSIs when com paring pad e

who did and did not receive MB P.'' ' ' Guenaga and

leagues-''' rep orte d rates of superficial SSIs as 7.4% (59/7

Table 4. Summary of evidence for anastomotic leaks for the

14 randomized controlled trials

Study

Brownson

e t a l .

Burke

et

a l . '

Santos et a l .

Filimann

et

a l .

Miett inen

et

al.'°

Young Tabusso

e t a l .

Fa-Si-Oen e t a l .

Zmora

et

a l . '

Bueher et a l .

Ram et ai. '

Pla te l le t a l .

Contant

et

al.'^

Jung

et

al.^^

Pena-Soria

et

a l .

No .

patients

134

169

149

60

267

47

250

38 0

153

329

294

1354

1343

97

Anastomotie

MB P

8/67

3/82

7/72

2/30

5/138

6/24

7/125

7/187

5/78

1/164

3/147

32/670

13/686

4/48

Mß P = mechanicai bowel prepa ration.

(12.0)

(3.7)

(9.7)

(6.7)

(3.6)

(21.0)

(5.6)

(3.7)

(6.4)

(0.6)

(2.0)

(4.8)

(1.9)

(8.3)

leaks, no.

( )

No MBP

1/67

(1.5)

4/87 (4.6)

4/77 (5.2)

1/30

(3.3)

3/129

(2.3)

0/23 (0)

6/125

(4.8)

4/193 (2.1)

1/75

(1.3)

2/165

(1.2)

7/147

(4.8)

37/684 (5.4)

17/657

(2.6)

2/49

(4.1)

value

0.030

0.91

0.29

1.00

0.72

0.050

0.78

0.33

0.21

1.00

0.20

0.60

0.39

0.44

Table 5. Summary of evidence for superficial surgical site

infections SSIs) for the 14 randomized controlled trials

Study

Brownson

et

a l .

Burke et al.°

Santos

et

a i .

Filimann

et

a l .

Miett inen e t a l .

Young Tabusso

e t a l .

Fa-Si-Oen e t a l .

Zmora

et

a l . '

Bucher e t a l .

Ram et al.

Platell et a l .

Contant

et

a i .

Jung

et

a l . ' '

Pena-Soria

et al. '

No.

patients

179

169^

149

60

267

47

250

38 0

153

32 9

294

1354

1343

97

Superfieial

MB P

5/86

4/82

17/72

1/30

5/138

2/24

9/125

12/187

10/78

16/164

19/147

90/670

54/686

6/48

MB P

=

mechanical bowel preparation.

(5.8)

(4.9)

(24.0)

(3.3)

(4.0)

(8.3)

(7.2)

(6.4)

(13.0)

(9.8)

(12.9)

(13.4)

(7.9)

(12.5)

SSIs, no.

%)

No MBP

7/93

3/87

9/77

2/30

3/129

0/23

7/125

11/193

3/75

10/165

21/147

96/684

42/657

6/49

(7.5)

(3.5)

(12.0)

(6.7)

(2.0)

(0)

(5.6)

5.7)

4.0)

6.1)

(14.3)

(14.0)

(6.4)

(12.2)

p valu

0.77

0.71

0.06

1.00

0.72

0.49

0.61

0.77

0.07

0.21

0.73

0.82

0.29

0.97



R E S E R H

in the MBP group and 5.4% (43/803) in the no MBP

group (OR 1.46, 95% CI 0.97-2.18, p = 0.07). In the meta-

analysis by Slim and colleag ues, the rate of superficial

SSIs in the MBP group was 9.5% compared with 8.3% in

the no M BP group (OR 1.17, 9 5% CI 0.96-1.44, p = 0.11).

Patients undergoing low anterior resections with or

without diverting ileostomy

It has been well documented that the risk of anastomotic

dehiscence is greater following low colorectal or coloanal

anastomoses, and these low anastomoses have been associ-

ated with high rates of morbidity and mortality.' ' For this

reason, many surgeons performing these operations opt to

protect the anastomosis with a diverting stoma. The use

or omission of MBP in patients undergoing low anterior

resection (LAR) with or without diverting stoma in par-

dcular poses a difficult dilemma and raises important con-

c e r n s . Surgeons may hes i t a te to omi t MBP in the se

patients because it would leave a column of stool between

the stoma and the anastomosis. In the event that such

patients experience an anastomotic leak, there would still

be a risk of fecal contamination despite the anastomosis

having been protected. In patients who do not receive a

diverting stoma, surgeons may also be concerned with the

potentially increased morbidity associated with an anasto-

modc leak.

Padents undergoing an LAR with a diverdng ileostomy

were poorly represented in the 14 RCTs included in our

review for 2 main reasons. Some RCTs (2 of 14) excluded

patients who underwent LAR or LAR with anastomoses

below the peritone al reflecdon.' '- Ot he rs (5 of 14) excluded

pad ents wh o had planned diver dng stomas.̂ ' *'-'•* Finally, in

some RCTs (3 of 14) the level of the anastomosis and

wheth er the patients had diverdng stomas was unclea r.' ' ' ' '

Five RCTs included padents undergoing LAR, and the

results of 4 of them'*''

'•* '

were included in a subgrou p analy-

sis reported in the Cochrane review.- ' ' In one of these

RCT s,'^ whe ther p adents received diverting stomas was no t

mendoned. In another,^ padents with diverdng stomas were

excluded, and th e othe r 2 s tud ies ' ' c lear ly s ta te th a t

padents did not receive diverdng stomas. When the results

of this subgroup of LAR padents from these 4 RCTs were

pooled in the Cochrane review, the rate of anastomotic

leakage for LAR was 9.8% (11 of 112) in padents in the

MBP group compared with 7.5% (9 of 119) in padents in

die no MBP group.- T he O R was 1.45 (95%C I 0.57-3.67,

p

0.40) and w as not stadsdcally significant, w ith 'wide 9 5%

CIs, likely because of the small sample size.' *

Th ere is 1 R C T published by Platell and colleagues ' '

that included a substantial proportion of padents having

LAR with diverdng stomas. This study was underpow ered

to show equivalence, although it did reveal stadsdcally sig-

nificant differences in some secondary outcomes. There-

fore, we gave this study a fair rating. Patients were ran-

or a single phosphate enema only. For the purpose of this

guideline, we considered the enema group to be the no

MBP group because none of these padents received an oral

MBP. In all, 147 padents were randomly assigned to MBP

and 147 patients to no MBP.-'' Sixty-four percent (94 of

147) of padents in the MBP group and 55% (81 of 147) of

pa t i en t s in the no MBP group unde rwent an an te r ior

resection.-' Furthermore, 39% (57 of 147) of patients in

die MBP group and 32% (47 of 147) of padents in the no

MBP group had a diverting stoma. The authors stated that

padents undergoing a low or ultra-low anterior resecdon

w e r e r o u t i n e l y c o v e r e d w i t h a d e f u n c t i o n i n g l o o p

ileostomy. -' There were 3 anastomodc leaks in the MBP

group and 7 in the no MBP group (2% and 4.8%, respec-

tively,

= 0.20).-'' How ever, n on e of the pa den ts in the

MBP group compared with the 6 padents in the no MBP

group required reo peration (0 % and 4. 1 % , respectively,

0.013).-' These results led to the trial being closed pre-

maturely. The mortality rate in the MBP group was 2.7%

compared with 0.7% in the no MBP group (OR 1.62,

95% CI 0.45-36.98,

0.18). T h er e was no significant dif-

ference in the rate of superficial SSIs between the MBP

and no MBP groups. ' '

These results are in contrast to those of all the other

RC Ts and meta-analyses. However, this trial differs in that

padents in the no MBP group received an enema. To make

further conclusions about the use of enemas in the pre-

operadve preparadon of patients undergoing elecdve colo-

rectal surgery, an RCT examining only the enema inter-

ven don w ould be required. W e included this trial in this

guideline because many surgeons who disagree with the

om iss ion of M BP c i t e th i s a r t i c le a s an example of

inc rea sed compl ica t ions when no MBP i s p re sc r ibed .

However, as demonstrated above, it is important to disdn-

guish this study from the others as it compares a different

intervent ion in addi t ion to comparing MBP versus no

M B P .

Patients undergoing laparoscopic colorectal resections

Although there are no studies examining the elfect of

MBP in padents undergoing elecdve laparoscopic surgery,

the evidence presented in this guideline likely can be

extrapolated to this population. There is no clinical reason

why padents having laparoscopic colorectal surgery would

be more likely to develop postoperadve infecdous compli-

cations. Some argue that M BP may be required in p adents

with small tumours that may not be appreciated laparo-

scopically, thus requiring intraoperative colonoscopy, but

preoperadve tattooing of the lesion would obviate such a

need. Some surgeons have also indicated that the unpre-

pared colon may be slightly heavier and thus difficult to

manipulate laparoscopically.

Adverse events associated wi th M P



R H R H

examined the adverse histological effects of MBP. There

were many other citations in the fonn of letters to the edi-

tor and case reports describing the adverse effects related

to MBP. The RCT published by Bücher and colleagues

reported the histological changes in intestinal mucosa

25 patients who had M BP w ith polyethylene glycol co

pared with 25 patients who did not receive MBP. Th

was a significant difference in the loss of superficial mu co

Table 6. Evidence from case reports reporting the adverse effects of mechanical bow el prepa ration (MBP)

Study

Gray and

Colwel l

Frizelle and

Colls

Ayus et al.

Mackey et al.

Hookey et al.'

Tan et

al, '

Ullah et al. '

ADRAC

Franga an d

Harris'

Boivin and

Kahn

Oh et

al.'

Vukasin et al.

ADRAC

Study type

Review

Case reports:

3 patients

Case reports:

4 patients

Letter to the

editor

Review:

20 publications

describing

adverse events

in 29 patients

Case reports:

6 patients

•

Case report

Case reports:

16 reports

Case report

Case reports:

2 patients

Case reports:

2 patients

Case report

Case reports:

3 reports

Type of preparation used

Polyethylene glycol

:

Sodium phosphate

2:

Sodium picosulfate/

magnesium citrate

3: Sodium phosphate

Polyethylene glycol

Sodium phosphate

Sodium phosphate

Sodium phosphate

Sodium phosphate

Sodium picosulfate

Polyethylene glycol

Sodium phosphate

: Magnesium citrate

2: Sodium phopshate

Sodium phosphate

Sodium phosphate

Outcome

Spontaneous rupture of the esophagus

Grand mal seizure activity, hyponatremia

1,2: Hyponatremia

3, 4: Hypematremia

4 cases of tonic-clonic seizures

Hypocalcemia, hypotension, hypematremia,

hypokalemia, renal failure, hypo volemia.

hyperphosphatemia

1, 2: Delayed awakening from general

anesthesia

3-6: Severe electrolyte abnormalities

Severe hyperphosphatemia, acute pulmonary

edema, cardiorespiratory arrest

Hyponatremia with seizures, hyponatremia/

hypokalemia with syncope, unconsciousness.

metabolic acidosis

Pancreatitis

: Hypocalcemia with severe tetany

2:

Hypocalcemia with perioral

numbness/tingling

1:

Ischémie colitis: patchy submucosal

hemorrhage and mucosal denudation

2:

Ischémie colitis: friable mucosa.

submucosal hemorrhage with ulcération

Severe hyperphosphatemia and hypocalcemia

with tetany

:

Hyperphosphatemia/hypocalcemia

2: Hypocalcaemia, hyponatremia and

hypokalemia

3: Hyperphosphatemia, hypocalcaemia,

paraesthesia, carpal spasm and

OT prolongation

ADRAC = Adverse Drug Reactions Advisory Committee; COPD = chronic obstructive pulmonary disease.

Comments

• 4 case reports: 3 patients survived after

surgical intervention, 1 death

• epilepsy has developed in of 3 patients

1

1:

Status epilepticus: complete recovery

2: Grand mal seizures: cardiac arrest, death

3: Metabolic alkalosis: respiratory arrest, death

4: Seizures, aspiration: cardiac arrest, death

• 4 patients with no history of seizure or

electrolyte abnormalities

• Attributed to electrolyte imbalance resulting i

seizures

• Many of these adverse events are attributed

inappropriate dos ing, pre-existing renal

impairment

• 4 of 29 patien ts did not have any clear or

probable predisposing factors (dose or relativ

contraindication)

1: Baseline chronic renal failure: developed

hypocalcemia, hypokalemia, hypematremia.

hyperphosphatemia and eventually required

long-term hemodialysis

2: Healthy: developed metabolic and respiratory

acidosis w ith ac ute renal failure and

completely recovered

3: Dehydration, breathlessness, complete

recovery

4:

Coma, complete recovery '

5: Tonic-clonic seizures, death

6: Seizures, central pontine m yelinosis, death

• 55-year-old man with diabetes, hypertension

and end-stage renal disease

• 4 reports of syncope and dehydration with out

concomitant electrolyte abnormalities

• 75-year-old wom an with a history of

hypertension, COPD, peripheral vascular

disease and no prior history of pancreatitis

• Progressed to develop pancreatic pseudocyst

1:

Attributed to chronic renal failure

2:

No history of renal disease; attributed to

magnesium depletion

: Took m agnesium citrate in preparation for a

screening sigmoidoscopy

2:

Previously had 5 colonoscopies with

polyethylene glycol or sodium phosphate

preparations and had no adverse reactions

• Otherw ise healthy patient, no renal failure

• All laboratory values returned to normal by

2 weeks i

1:

Followed by renal failure and death (90-year-o

man with no history of renal failure)

2: Dehydration and subsequent death (70-year-o

woman with no history of renal failure)

3: Required hemodialysis; patient had history of

renal failure



RESEARCH

p < 0.001), loss of ep ithelial cells p < 0.01), edema of th e

lamina propria p 0.01), lymphocyte infiltradon p 0.02)

and polymorphonuclear cell infiltradon p 0.02) when the

2 groups were compared. These changes were all more fi e-

quent in those patients who had received MBP. /Vlthough

it is unclear if these morphological changes are clinically

relevant, they could potendally result in bacterial trans-

locadon and anastomodc disrupdon. '^

W e reviewed 13 oth er selected árdeles describing the

adverse effects of MBP. *^ T h e details of these m an u-

scripts can be seen in Table 6. In brief these case reports

revealed that many of the different types of MBP, such as

sodium picosulfate, polyethylene glycol, sodium phosphate

and magnesium c i t ra te , were assoc ia ted with adverse

effects. ^'•^' ''* The primary adverse effects were related to

e lec t ro ly te and volume d i s turbances in bo th hea l thy

padents and padents with underlying cardiac or renal dis-

ease. Furthermore, these electrolyte disturbances led to

seizures, syncope, coma and even death in some padents.

Finally, there have also been reports of MBP-associated

ischémie colids, pancreadds and esophageal perforadon. ^' *

Dietary m odifications

one of the 14 RCTs included in this review performed a

d i rec t compar i son of d i f f e ren t d ie ta ry mod i f ica t ions

be fore surge ry . Ta ble 7 de sc r ibe s the spec if i c M BP ,

dietary modificadons and enemas that were used in each

roup in each RC T. Nin e of the 14 RC Ts sdpulated no

Table 7. Description of interven tions

Study

Brownson et al.

Burke et al.'

Santos et al.

Fillmann

et

a l .

Miett inen et al.

Young Tabusso

et

al.

Fa-Si-Oenetal .

Zmora et al.'

Bûcher et a l.

Ram et al.

Platell et al .

Contant et al.

Jung

e t

a l .

Pena-Soria

MBP intervention

PEG

Sodium picosulphate,

CitraFleet x 24 h

Mineral oil 3 times/d x

5 d, optimal dose.enema

2 d, CitraFleet x 24 h

Mann itol + orange juice

PEG,

no solid food

Mann itol or PEG,

CitraFleet x 48 h

PEG

PEG,

DA T, enenna for

rectal resections

PEG,

DAT, enema for

anterior resections

Sodium phosphate, low-

residue diet

PEG,

CitraFleet x 24

h

PEG or sodium

phosphate, FF x 24 h

PEG,

sodium phosphate

or enema

PEG enemas, dietary

restrictions x 24 h

No MBP intervention

—

DA T

Low-residue diet x 24 h

Orange juice

DA T

CitraFleet x 48 h

DAT until 10 h before

surgery

DAT, enem a for rectal

resections

DAT, enema for anterior

resections

Low-residue diet x 24 h

Enema, CitraFleet x 24 h

DA T

DA T

DA T

DAT = diet as tolerated: FF = full-fluid diet; MBP = mechanical bow el preparation;

PEG = percutaneous endoscopie gastrostomy.

dietary restricdons before surgery, and padents in the no

MBP arm received a normal or low-residue diet on the

day before surgery. Since most of these trials allowed

padents in the no MBP arm to have a normal diet before

surgery and these patients did not have increased post-

operadve infecdous complicadons, it is likely safe to omit

dietary modificadons in the preoperadve management of

padents u ndergo ing elecdve colorectal surgery.

Enemas

Again, none of the 14 RCTs included in this review per-

formed a direct comparison of enema versus no enema

before surgery. Th ree of the 14 RC Ts prescribed enemas

for left-sided or rectal resections in patients in the no

M BP group.̂ '*-^' Also, in 5 of the 14 RC Ts , pad ents in die

MBP group also had an enema.' ' '''''^* Applying this evi-

dence, it is difficult to draw conclusions and make recom-

mendations regarding the use or omission of enemas in

padents un dergoin g elecdve colorectal surgery.

DISCUSSION

Summary of th evidence

Most of the evidence supports the omission of MBP and

reveals that MBP is not associated with an increased risk of

anastomodc dehiscence. Furthermore, there appears to be

no difference in other postoperadve complicadons, such as

superficial SSIs. Based on the population of patients in

these trials, these results can be applied to padents under-

going elecdve, open right-sided and left-sided colorectal

resecdons. Mechanical bowel preparadon is generally safe,

but it has been associated with serious complicadons in

padents with exisdng cardiac and renal disease as well as

previous ly hea l thy pa t ients . Fur thermore , most pa t ients

find MBP to be unpleasant. Thus, the use of MBP has not

been shown to be beneficial, but rather has been shown to

be associated with rare but serious adverse effects.

There is less evidence regarding patients undergoing

LAR with or without a diverdng ileostomy. After thorough

assessment of the included R CT s, only 1 provided a com -

parison of MBP and no MBP in this specific populadon,

and all others excluded this group of padents. This fair-

quality RCT revealed that patients receiving MBP had

lower rates of anastomodc dehiscence, but this was not sta-

tistically significant.-' This study was designed to be an

equivalence study but was ended early owing to the need

for reoperadons in padents who experienced a leak. How-

ever, all padents in the no MBP group received a phos-

phate enema, which might account for the differences seen

between the 2 groups. Furthermore, the Cochrane review

included a subgroup analysis of padents tindergoing LAR

and showed no stadsdcally significant difference in anasto-



RECHERCHE

Padents undergoing laparoscopic colorectal resecdons

are not included in any of the RCTs discussed in this

guide l ine . The resul ts f rom the inc luded RCTs where

padents underwent open procedures, however, hkely can

be generalized to this padent populadon.

ecommend tions

A synthesis of tbe level-I evidence reveals that there is

good evidence suppor t ing the omiss ion of MBP in the

preoperative management of padents undergoing elecdve

right-sided and left-sided colorectal surgical resections

(grade A recommendation). Examining the data specifi-

cally for paden ts underg oing LAR with or without divert-

ing stomas has revealed that there is insufficient evidence

to support or refute the omission of MBP in the preopera-

dve management of these padents (grade I recommenda-

tion). There is no specific evidence regarding patients

undergoing laparoscopic colorec ta l surgery. Therefore ,

there is insufficient evidence to support or refute the

omiss ion of MBP in the preope ra t ive management of

pa t i en t s unde rgoing e lec t ive l apa roscopic co lorec ta l

surgery (grade I recomm endation).

Although there is some heterogeneity when evaluadng

dietary modifications before elective colorectal surgery,

most RCTs allowed padents in tbe no MBP group to con-

sume a regular die t unt i l midnigbt on the day before

surgery. These intervendons have revealed that there is fair

evidence to recommend nonnal diet undl midnight the day

before surgery in the preoperadve management of padents

undergoing elecdve colorectal surgery (grade B recommen-

dadon). Finally, there is insufficient evidence to support or

refute the use of enemas in the preoperadve m anagem ent of

paden ts und ergoing elecdve colorectal surgery (grade I rec-

ommendadon) .

These recommendadons are driven mosdy by the 2 large

RC Ts'--' ' and the 3 recent meta-a nalyses.' ' ' ' ' Although the

prim ary R C T s have no t shown a stadsdcally significant dif-

ference in postoperadve complicadons when comparing the

M BP and no MB P groups, the comm on flaw in these stud-

ies is inadequate sample size and power. The udlity of the

meta-analyses is directed at this pardcular problem. Fur-

tbermore, tbe reports surrounding adverse effects of MBP

reveal that although complicadons are rare and more com-

mon in individuals with underlying cardiac and renal dis-

ease, these com plicadons are extremely serious. Takin g into

account the lack of difference in postoperative infectious

complicadon rates when MBP is omitted and the adverse

effects of MBP, we believe tbat we are jusdfied in making a

strong recommendadon based on the Uterature.

Competing interests None declared.

Contributors

All authors helped design the study, review and article

and approved its publication. Drs. Eskicioglu and Forbes acquired and

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