Mechanical Bowel Prep Elective Colorectal Surgery Cochrane

Mechanical bowel preparation for elective colorectal surgery
(Review)
Guenaga KKFG, Atallah ÁN, Castro AA, Matos D, Wille-Jørgensen P
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2008, Issue 4
http://www.thecochranelibrary.com
Mechanical bowel preparation for elective colorectal surgery (Review)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Analysis 1.1. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 1 Anastomosis leakage 20
stratified for colonic or rectal surgery. . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.2. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 2 Overall anastomotic 22
leakage for colorectal surgery. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.3. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 3 Mortality. . . . . 23
Analysis 1.4. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 4 Peritonitis. . . . . 23
Analysis 1.5. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 5 Reoperation. . . . 24
Analysis 1.6. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 6 Wound infection. . 24
Analysis 1.7. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 7 Infectious extra- 25
abdominal complications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.8. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 8 Non-infectious extra- 26
abdominal complications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.9. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 9 Surgical site infections. 26
Analysis 1.10. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 10 Sensitivity analysis 1 - 27
Studies with dubious randomisation procedure excluded. . . . . . . . . . . . . . . . . . . .
Studies published as abstract only excluded. . . . . . . . . . . . . . . . . . . . . . . .
Studies including children excluded. . . . . . . . . . . . . . . . . . . . . . . . . . .
Studies including patients without anastomosis excluded. . . . . . . . . . . . . . . . . . . .
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
NOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Mechanical bowel preparation for elective colorectal surgery (Review) i

[Intervention review]
Mechanical bowel preparation for elective colorectal surgery
Katia KFG Guenaga1 , Álvaro N Atallah2 , Aldemar A Castro3 , Delcio Matos4 , Peer Wille-Jørgensen5
1 Surgical
Gastroenterology Department, Ferderal University of São Paulo, Guarujá, Brazil. 2 Brazilian Cochrane Centre, Universidade
Federal de São Paulo / Escola Paulista de Medicina, São Paulo, Brazil. 3 Department of Public Health, State University of Heath
Science, Maceió, Brazil. 4 Brazilian Cochrane Centre, Universidade Federal de São Paulo, São Paulo, Brazil. 5 Department of Surgical
Gastroenterology K, Bispebjerg Hospital, Copenhagen NV, Denmark
Contact address: Katia KFG Guenaga, Surgical Gastroenterology Department, Ferderal University of São Paulo, Marivaldo Fernandes,
152 apto. 13, Guarujá, São Paulo, 11 440-050, Brazil. kaci@uol.com.br. (Editorial group: Cochrane Colorectal Cancer Group.)
Cochrane Database of Systematic Reviews, Issue 4, 2008 (Status in this issue: Edited)
DOI: 10.1002/14651858.CD001544.pub2
This version first published online: 24 January 2005 in Issue 1, 2005. Re-published online with edits: 8 October 2008 in Issue 4,
2008.
Last assessed as up-to-date: 20 October 2004. (Dates and statuses?)
This record should be cited as: Guenaga KKFG, Atallah ÁN, Castro AA, Matos D, Wille-Jørgensen P. Mechanical bowel
preparation for elective colorectal surgery. Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD001544. DOI:
10.1002/14651858.CD001544.pub2.
ABSTRACT
Background
For over a century the presence of bowel content during surgery has been linked to anastomotic leakage. Mechanical bowel preparation
has been considered an efficient agent against leakage and infectous complications. This dogma is not based on solid evidence, but on
observational data and expert’s opinions.
Objectives
To determine the effectiveness and safety of prophylactic mechanical bowel preparation for morbidity and mortality rates in elective
colorectal surgery.
Search strategy
We searched MEDLINE, EMBASE, LILACS, and the Cochrane Central Register of Controlled Trials. We also searched relevant
medical journals, and conference proceedings from major gastroenterological congresses and contacted experts in the field. We used
the search strategy described by the Colorectal Cancer Review Group, without limitations for date of publication and language. I
Selection criteria
Randomised, clinical trials that compared any strategy in mechanical bowel preparation with no mechanical bowel preparation.
Data collection and analysis
Data were independently extracted by the reviewers and cross-checked. The same reviewers assessed the methodological quality of each
trial. Details of the randomisation (generation and concealment), blinding, whether an intention-to-treat analysis was done, and the
number of patients lost to follow-up was recorded. For analysis the Peto odds ratio (OR) was used as defaults.
Main results
Mechanical bowel preparation for elective colorectal surgery (Review) 1
Of the 1592 patients (9 trials), 789 were allocated to mechanical bowel preparation (Group A) and 803 to no preparation (Group B)
before elective colorectal surgery. For anastomotic leakage (main outcome) the results were:
- Low anterior resection: 9.8% (11 of 112 patients in Group A) compared with 7.5% (9 of 119 patients in Group B); Peto OR 1.45,
95% confidence interval (CI): 0.57 to 3.67 (non-significant);
- Colonic surgery: 2.9% (Group A) compared with 1.6% (Group B) ; Peto OR 1.80, 95% CI: 0.68 to 4.75 (non-significant);
Overall anastomotic leakage: 6.2% (Group A) compared with 3.2% (Group B); Peto OR 2.03, 95% CI: 1.276 to 3.26 (p=0.003).
For the secondary outcome of wound infection the result was: 7.4% (Group A) compared with 5.4% (Group B); Peto OR 1.46, 95%
CI: 0.97 - to 2.18 (p=0.07);
Sensitivity analyses excluding studies with dubious randomisation, studies published as abstracts only, and studies involving children
did not change the overall conclusions
Authors’ conclusions
There is no convincing evidence that mechanical bowel preparation is associated with reduced rates of anastomotic leakage after elective
colorectal surgery. On the contrary, there is evidence that this intervention may be associated with an increased rate of anastomotic
leakage and wound complications. It is not possible to be conclusion on the latter issue because of the clinical heterogeneity of
trial inclusion criteria, methodological inadequacies in trial (in particular, poor reporting of concealment and allocation), potential
performance biases, and failure of intention-to-treat analyses. Nevertheless, the dogma that mechanical bowel preparation is necessary
before elective colorectal surgery should be reconsidered.

PLAIN LANGUAGE SUMMARY
Key findings: Preoperative mechanical bowel preparation before colorectal surgery does not reduce anastomotic leakage.
Preoperative mechanical bowel preparation before colorectal surgery is a widely-practised treatment, but its efficacy has never been
proven outside observational studies and animal experiments.
This systematic review of nine trials (1592 patients) found that there is no convincing evidence that mechanical bowel preparation is
associated with reduced rates of anastomotic leakage after elective colorectal surgery, but on the contrary, there is evidence that this
intervention may be associated with an increased rate of anastomotic leakage and wound complications.
There was no difference in other outcomes, such as mortality, peritonitis, re-operation, infectious extra-abdominal complication, non-
infectious extra-abdominal complication, and surgical site infection.
Mechanical bowel preparation before colorectal surgery cannot be recommended as routine.
BACKGROUND Schein 1995), and clinical trials in emergency surgery (Baker 1990;
Dorudi 1990; Duthie 1990) have been published in order to sup-
The importance of efficient mechanical bowel preparation in pre-
port this theory.
venting infectious complications and anastomotic dehiscence after
colorectal surgery has been a dogma among surgeons for more than Two randomised trials from Ireland and Brazil concluded that the
a century (Halsted 1887 ; Thornton 1997 ). Clinical experiences role of bowel preparation in colorectal surgery requires re-evalua-
and observational studies have shown that mechanical removal of tion (Burke 1994; Santos 1994). If bowel preparation is shown to
gross faeces from the colon has been associated with decreased be needless, it could mean a shorter hospital stay for the patient
morbidity and mortality in patients undergoing operations of the and avoidance of the potential complications associated with the
colon (Nichols 1971). One author (Chung 1979) was categorical: cleansing procedure such as gastric intolerance, low serum potas-
“One of the most important factors within the control of the sur- sium level, bowel explosion, mucosal lesions, electrolyte distur-
geon, that affect the outcome of a colonic operation, is the degree bance and fluid overload.
of emptiness of the bowels”.
Analysed in isolation, the results of published trials have not shown
An early randomised clinical trial questioned this view and con- any significant difference in outcomes between patients who un-
cluded that vigorous mechanical bowel preparation is not neces- derwent mechanical bowel preparation and those who did not,
sary (Hughes 1972). Omission of enemas and bowel washes from but as the individual studies contain a high risk of a statistical type
the preoperative procedures will be welcomed by both patients II error it seemed justified to perform a meta-analysis.
and nursing staff.
One trial (Irving 1987) questioned the necessity of preoperative or
intra operative mechanical bowel preparation of the colon, before OBJECTIVES
primary anastomosis. The authors argue that preoperative bowel To determine the necessity of prophylactic mechanical bowel
preparation is time-consuming, expensive, and unpleasant for pa- preparation in patients undergoing elective colorectal surgery.
tients - even dangerous on occasion - and completely unnecessary.
Traditionally, “bowel preparation” has been used to reduce faecal The incidence of anastomotic dehiscence is increasing as more
mass and also bacterial counts. Most surgeons consider mechan- anal the anastomosis is performed (Goligher 1970). Because bowel
ical bowel preparation to be essential, and the systematic admin- preparation might have different effect in colon and rectum, we
istration of appropriate antibiotics has been shown effective in re- will stratify the analyses for colon and rectum separately whenever
ducing infectious complications in numerous randomised trials. possible.
Furthermore, mechanical bowel preparation is recommended by
many guidelines from surgical associations and scientific societies
(ASCGBI 2001; Moore 1999; SIGN 1997). METHODS
Different methods of mechanical bowel preparation have been
tested and approved and the potential danger of having faeces Criteria for considering studies for this review
in contact with a newly performed anastomosis when the colon
was not prepared has been discussed (Grabham 1995 ; Mealy
Types of studies
1992 ). Both experimental studies (Smith 1983; O’Dwyer 1989;
(i) Randomised clinical trials comparing preoperative mechanical 13) Anastomotic leakage and wound infection in studies in which
bowel preparation versus no preparation (or placebo) in bowel continuity was restored.
(ii) patients undergoing elective colorectal surgery and in which
(iii) the primary outcome (anastomotic leakage) is clearly stated
in both treatment arms. Search methods for identification of studies
To be included in this review, trials had to meet all three criteria. See: Collaborative Colorectal Cancer Review Group search strat-
EXCLUSION CRITERIA: egy (Wille-Jørgensen 1999).
Studies evaluating two or more different cleansing methods; stud- The studies were identified from the following sources: MED-
ies including patients undergoing emergency surgery. LINE, EMBASE, CINAHL, LILACS, SCISEARCH, Controlled
Clinical Trials Database, Trials Register of the Cochrane Colorec-
Types of participants tal Cancer Group, and the Cochrane Central Register of Con-
Patients undergoing elective colorectal surgery. trolled Trials (CENTRAL). Reference lists were checked, hand-
searching was carried out, and through letters sent to study au-
thors. Conference proceedings from major gastrointestinal confer-
Types of interventions
ences (World Congress of Gastroenterology, Annual Meetings of
Any strategy in mechanical bowel preparation for patients under- American Sociery of Colon and Rectal Surgery, Annual meetings
going elective colorectal surgery compared to no mechanical bowel of Association of Coloproctology of Great Britain and Ireland,
preparation. Tripartites meetings) were scrutinised back to 1994 (last possible
retrieval of abstract-material). There were no limits regarding lan-
Types of outcome measures guage, date, or other restrictions in the searches. All searches were
PRIMARY OUTCOME MEASURES: performed up to July 2004.
1) Anastomotic leakage, defined as discharge of faeces from the Search strategy:
anastomosis site, externalising through the drainage opening or #1 Cochrane Collaboration search strategy for randomised con-
the wound incision; or just the existence of an abscess adjacent to trolled trials (Handbook 2004)
the anastomosis site. The anastomotic leakage was confirmed by #2 Tw INTESTIN* or Tw BOWEL
either clinical or radiological investigation. #3 Tw LARGE or Tw GROSSO or Tw GRUESO
The type of surgery and anastomosis site were stratified in: #4 #2 and #3
A: Low anterior resection, extra-peritoneal anastomosis (rectum #5 Tw COLO* or Tw CECO
considered extra-peritoneal); #6 Tw RECT* or Tw RET*
B: Colonic surgery, intra-peritoneal anastomosis. #7 #4 or #5 or #6
2) Overall anastomotic leakage: total number of anastomotic de- #8 #3 and #7
hiscence in all of colon and rectum. #9 Tw PREPARA*
SECONDARY OUTCOME MEASURES: #10 Tw SURGERY or SURGICAL
3) Mortality: number of postoperative deaths related to the surgery. #11 #8 and #9 and #10
4) Peritonitis: presence of postoperative infections at the abdomi- #12 #1 and #11
nal cavity, localized (abscess) or not.
5) Re-operation: surgical re-intervention for anastomotic compli-
Data collection and analysis
cation.
6) Wound infection: defined as a discharge of pus from the ab- LOCATING AND SELECTING STUDIES
dominal wound. The reviewers (KFG and PWJ) independently selected the trials to
7) Infectious extra-abdominal complication: postoperative infec- be included in this review. Disagreement on selection was solved
tious complication at extra-abdominal site. in a consensus meeting. Only studies designed and stated as ran-
8) Non-infectious extra-abdominal complications (e.g. deep ve- domised controlled trials were considered for inclusion.
nous thrombosis, cardiac complications, wound rupture). CRITICAL APPRAISAL OF STUDIES
9) Overall infections in surgical sites. The reviewers assessed the methodological quality of each trial. We
SENSITIVITY AND SUBGROUP ANALYSES recorded details of the randomisation method, blinding, whether
10) Anastomotic leakage and wound infection in studies with an intention-to-treat analysis was done, and the number of patients
adequate randomisation. lost to follow-up to evaluate the risk of bias in the individual
11) Anastomotic leakage and wound infection in studies published studies (Handbook 2004). We assessed the external validity of the
as full articles. studies in an analysis of the characteristics of the participants and
12) Anastomotic leakage and wound infection in studies only deal- the interventions as collected below.
ing with adult patients. COLLECTING DATA

We included studies in which allocation concealment was regarded included, and one study previously included as an abstract is now
adequate were included. A few studies with unclear allocation included as a full paper version.
concealment were included as well . The reviewers independently
extracted and cross-checked the data. The result of each trial was
summarised in 2 x 2 tables for each outcome. RESULTS
We evaluated study validity according to participants and inter-
ventions: Description of studies
PARTICIPANTS: Category of disease (colorectal cancer, inflam-
See: Characteristics of included studies; Characteristics of excluded
matory disease, megacolon, polyposis, diverticular disease), gen-
studies.
der, age, topography, operative procedure, antibiotic therapy, sur-
We identified fourteen studies of which nine were included, and
geon experience. The calculation of the sample size and the sample
five trials were excluded. The reason for exclusion was absence
representativeness was observed.
of a control group (Irving 1987 , Dorudi 1990 , Duthie 1990 ),
INTERVENTIONS: Types of mechanical bowel preparation: an-
elemental diet in the control group (Matheson 1978), or lack of
terograde (oral) or retrograde (enemas) versus no mechanical bowel
description of the primary outcome and insufficient description
preparation.
of the secondary outcomes (Hughes 1972) see “Characteristics of
Information data from the studies published more than once, was
excluded studies”.
only included once.
One of the included studies was published in Portuguese (Fillmann
Data were entered into Review Manager 4.2 by single data-entry
1995 ), and identified in the Lilacs database. One study was in
by KFG and controlled by PWJ.
Spanish (Tabusso 2002 ). The others were published in English
ANALYSING AND PRESENTING RESULTS
language. Three studies were published as abstracts only (Brown-
If appropriate we stratified the studies for different meta-analy-
son 1992, Bucher 2003 , Fa-Si-Oen 2003 ). Data from the latter
sis (Review Manager 4,2) according to the analysis of the defined
study were retrieved from another publication (Slim 2004).
outcomes. We used various techniques: in the dichotomous out-
Three new studies were identified and included in this update
come measures, the combined logarithm of the Peto Odds Ratio
(Bucher 2003 , Tabusso 2002 , Fa-Si-Oen 2003 ). Two were con-
(fixed effect model) was used as default. We performed a test for
ference proceedings (Bucher 2003, Fa-Si-Oen 2003).
statistical heterogeneity in each case. If we detected heterogeneity,
TYPES OF PARTICIPANTS
results were reported as Odds Ratio using random-effects mod-
The inclusion criteria was the same for all studies: patients ad-
elling. For the analysis, we reviewed only patients who underwent
mitted for elective colorectal surgery. One trial (Santos 1994) in-
elective colorectal surgery; according to type of interventions, type
cluded children. Two studies included patients without anasto-
of participants, to assess whether there were important differences
mosis (Fillmann 1995, Santos 1994); one study (Brownson 1992)
between them. All inclusion criteria had to be met.
excluded these patients in only one of the outcomes: anastomosis
We assessed statistical heterogeneity and potential publication bias
leakage; two of them (Burke 1994, Miettinen 2000) excluded pa-
in the results of the meta-analysis both by inspection of graphical
tients for whom bowel continuity was not restored.
presentations (“funnel plot”: plotting the study weight or sample
In two of the new trials included in the review (Bucher 2003 ,
size (on the “Y” axis) against the Odds Ratio (on the “x” axis)
Tabusso 2002) one of the inclusion criteria was patients undergo-
and by calculating a test of heterogeneity (standard chi-squared
ing elective “left-sided” colorectal surgery. One new trials stated
test on N degrees of freedom where N equals the number of tri-
only “elective colorectal surgery” (Fa-Si-Oen 2003).
als contributing data minus one). The funnel plot is possible for
None of the studies reported the use of preoperative adjuvant
outcomes described in five or more studies. Three possible reasons
chemotherapy or radiation. Seven stated use of prophylactic an-
for heterogeneity were pre-specified: (i) that responses differ ac-
tibiotics, and there was no information on this from two studies
cording to difference in the quality of the trial; (ii) that response
(Zmora 2003, Bucher 2003) .
differ according to sample size; (iii) that response differ according
Five trials (Burke 1994, Fillmann 1995, Miettinen 2000, Santos
to clinical heterogeneity. If we detected heterogeneity, sensitivity
1994, Zmora 2003) described the two allocation groups as being
analyses were performed in subgroups.
equal according to gender, age, types of operation, and diagnosis.
SENSITIVITY ANALYSIS.
Three of them (Brownson 1992, Bucher 2003, Fa-Si-Oen 2003)
We used a fixed sample model with Peto Odds ratio was used as
did not give details. One (Tabusso 2002 ) described a statistic
default. If heterogeneity was apparent, a random effects model was
difference between the two groups regarding age, hemoglobin level
applied.
and serum albumin.
IMPROVING AND UPDATING THIS REVIEW
The criteria for exclusion of patients were reported in different
As a minimum, updates will be considered on an biannual basis.
ways: A) patients who had been taken antibiotics for at least 15
This is the first update performed two years after the first appear-
days before surgery, or if there was evidence of infection, or any as-
ance in The Cochrane Library. Three additional studies have been
sociated disease requiring antibiotic therapy, and patients in whom

the mechanical bowel preparation was not feasible (Santos 1994); 1994, Fillmann 1995, Miettinen 2000, Santos 1994, Zmora 2003).
B) any patients who could not tolerate the preparation; C) patients 4) Peritonitis: four of the studies (Brownson 1992, Fillmann 1995,
who had bowel preparation for colon one week before surgery, Miettinen 2000,Tabusso 2002) included this.
patients who where unable to drink the solution, patients not re- 5) Re operation: four trials described this outcome (Burke 1994,
quiring opening of the bowel, and one patient who refused to be Fillmann 1995, Miettinen 2000, Santos 1994).
randomised (Miettinen 2000); D: Two trials excluded patients in 6) Wound infection: all of the included studies described it
whom bowel continuity was not restored (Burke 1994, Miettinen (Brownson 1992, Bucher 2003 , Burke 1994 , Fa-Si-Oen 2003 ,
2000). One trial (Brownson 1992) excluded the patients in whom Fillmann 1995 , Miettinen 2000 , Santos 1994 , Tabusso 2002 ,
bowel continuity was not restored in the analysis of the primary Zmora 2003).
outcome: anastomotic leakage. E: One of the trials (Zmora 2003) 7) Infectious extra-abdominal complication: two studies
included only patients with primary anastomosis. F) no patients (Fillmann 1995; Miettinen 2000) described this outcome.
were excluded, (Fillmann 1995 ) ; G) did not give details on ex- 8) Non-infectious extra-abdominal complication: four studies
clusion (Brownson 1992, Bucher 2003, Tabusso 2002, Fa-Si-Oen (Burke 1994; Fillmann 1995; Miettinen 2000, Zmora 2003) de-
2003 ). scribed this.
Two studies, (Fillmann 1995 , Santos 1994 ), included patients 9) Surgical site infection: two studies (Miettinen 2000 , Zmora
undergoing any of the following surgical procedures: abdomi- 2003).
nal excision of the rectum, Hartman’s procedure, defunctioning OTHER CHARACTERISTICS
colostomy, colonic anastomosis with colostomy; some of the pa- None of the studies contained an indication of how the sample
tients without anastomosis. One of the trials (Tabusso 2002) in- size was calculated. One author (Fillmann 1995 ) replied to our
cluded patients without anastomosis. enquiry that the sample size was calculated, but didn’t give more
TYPES OF INTERVENTIONS details. Two of the studies(Burke 1994, Miettinen 2000) described
All of the included studies compared mechanical bowel prepara- the sampling as consecutive.
tion with no preparation of the bowel prior to colorectal surgery : SENSITIVITY ANALYSIS AND SUBGROUP ANALYSES ON
Preparation of the bowel was either polyethylene glycol electrolyte ANASTOMOTIC LEAKAGE AND WOUND INFECTION
solution; laxatives (mineral oil, agar and phenolphthalein); man- In five of the studies (Brownson 1992, Bucher 2003, Burke 1994,
nitol; enemas (water, 900 ml; glycerin, 100 ml); sodium picosul- Tabusso 2002 , Fa-Si-Oen 2003 ) the allocation method was not
phate 10 mg; Bisacodyl (10 mg)+enemas; and diets, low and non- well-described . A sensitivity analysis was performed leaving out
residue. these studies (outcome 10). As three of the studies (Brownson
Only two studies mentioned the experience of the surgeon. wo 1992, Bucher 2003; Fa-Si-Oen 2003) were published as abstracts,
of them (Burke 1994, Miettinen 2000) described the operations an analysis was performed, leaving out these studies (outcome 11).
performed by or under the supervision of a consultant surgeon; In one study (Santos 1994) children were included. This study was
one (Santos 1994), described the operations performed by senior excluded in the third sensitivity analysis (outcome 12). In three of
residents. the trials (Fillmann 1995 , Santos 1994, Tabusso 2002 ) patients
The duration of follow-up was described as follows: A) 30 days or without anastomosis were included and an analysis was carried out
until hospital discharge (Santos 1994 ); B) 30 days after surgery without these studies(outcome 13).
(Fillmann 1995 , Zmora 2003 ) ; C) 1-2 months after surgery
(Miettinen 2000 ); D) less clearly (Burke 1994 , Tabusso 2002 ):
7 days after surgery ; E) not described (Brownson 1992, Bucher Risk of bias in included studies
2003, Fa-Si-Oen 2003).
None of the studies used an intention to treat analysis.
TYPES OF OUTCOMES MEASUREMENTS
SELECTION BIAS (Systematic differences in comparison
PRIMARY OUTCOMES
groups)
1) Anastomotic leakage: two of the studies (Burke 1994; Miettinen
In two trials (Santos 1994, Miettinen 2000), the allocation process
2000) stratified the anastomosis between rectal and colonic. Data
was described as randomised cards. One author (Fillmann 1995)
on stratification were obtained by personal contact with two au-
replied to our enquiries and described the process using a random
thors (Zmora 2003, Santos 1994). The others (Brownson 1992,
number table. In one study a computer generated list was used
Fillmann 1995, Tabusso 2002, Fa-Si-Oen 2003) did not refer to
(Zmora 2003 ). In these studies the allocation process was con-
the site of the anastomosis. Two studies described all anastomosis
sidered sufficient. In the others (Brownson 1992, Bucher 2003 ,
to be left-sided (Bucher 2003, Zmora 2003).
Burke 1994, Tabusso 2002, Fa-Si-Oen 2003), the allocation pro-
2) Overall anastomotic leakage: All the included studies described
cess was not clearly specified and thus considered unclear, leading
this outcome.
to a sensitivity analysis. In general, the allocation concealment in
SECONDARY OUTCOMES
all studies was not described. This is known to create biases (Juni
3) Mortality: five of the studies described this outcome (Burke
2002).

PERFORMANCE BIAS (Systematic differences in care provided (Burke 1994), and 35 from a third (Zmora 2003). In two studies
apart from the intervention being evaluated) no patients were excluded (Fillmann 1995, Miettinen 2000). The
None of the studies reported the use of preoperative adjuvant others, gave no information on exclusion (Brownson 1992, Bucher
chemotherapy or radiation. They all used prophylactic antibiotics, 2003, Tabusso 2002, Fa-Si-Oen 2003).
and all but two (Brownson 1992, Bucher 2003 ) described the
two allocation groups as being equal according to gender, age,
types of operation, and diagnosis. Another one (Tabusso 2002 ) Effects of interventions
indicated a difference between the allocation groups with the age,
Nine randomised controlled trials including a total of 1592 pa-
haemoglobin level and serum albumin. No relevant performance
tients, of whom 789 were allocated for mechanical bowel prepa-
bias was thus detected
ration (Group A), and 803 for no bowel preparation (Group B)
BLINDING
prior to elective colorectal surgery were included.
One trial (Fillmann 1995) described as a double-blind, in which
The results of each outcome were:
orange juice was used as placebo, must be considered only to the
PRIMARY OUTCOMES:
surgeon due to the differences in taste for the patient between
1) Anastomotic leakage - stratified:
the intervention and the control. One study (Burke 1994 ) was
A) Low anterior resection: 9.8% (11 of 112 patients in Group A)
described as a single-blind study, as the surgeons were aware of
compared to 7.5% (9 of 119 patients in Group B); Peto OR 1.45,
allocation of patients to bowel preparation. The rest of the studies
95% CI: 0.57 to 3.67 (non-significant) - no statistical heterogene-
contained no mention of blinding methods.
ity (Burke 1994, Miettinen 2000, Santos 1994, Zmora 2003);
ATTRITION BIAS (Systematic differences in withdrawals from
B) Colonic surgery: 2.9% (11 of 367 patients in Group A) com-
the trial)
pared to 1.6% (6 of 367 patients in Group B) ; Peto OR 1.80,
Brownson 1992, Bucher 2003, Tabusso 2002, Fa-Si-Oen 2003 did
95% CI: 0.68 to 4.75 (non-significant) - no statistical heterogene-
not describe withdrawals or dropouts. Burke 1994 had 9.1% (17/
ity (Burke 1994, Miettinen 2000, Santos 1994, Zmora 2003);
186 patients) withdrawal, and no dropout; Santos 1994 , with
2) Overall anastomotic leakage:
5% (8/157 patients) withdrawal, and no dropout, and Zmora
Overall anastomotic leakage: 6.2% (48 of 772 patients in Group
2003 8.6% (35/415). Two trials (Fillmann 1995, Miettinen 2000)
A) compared to 3.2% (25 of 777 patients in Group B); Peto OR
described that all patients completed the study. The author of
2.03, 95% CI: 1.276 to 3.26 (p=0.003) - no statistical hetero-
Fillmann 1995 supplied this information on written request.
geneity. (Brownson 1992, Bucher 2003 , Burke 1994 , Fillmann
DETECTION BIAS (Systematic differences in outcomes assess-
1995 , Santos 1994 , Miettinen 2000 , Tabusso 2002 , Zmora
ment)
2003,Fa-Si-Oen 2003);
No studies described any kind of concealment of assessment was
SECONDARY OUTCOMES:
described, except for the blinding procedure in the Fillmann-study
3) Mortality: 1% (5 of 509 patients in Group A) compared to 0.6%
(Fillmann 1995).
(3 of 516 patients in Group B); Peto OR 1.72, 95% CI: 0.43 to
(Burke 1994 ) measured the incidence of anastomotic leakage in
6.95 (non-significant) - no statistical heterogeneity (Burke 1994,
the first half of the study by performing water soluble contrast
Fillmann 1995, Miettinen 2000, Santos 1994, Zmora 2003);
enemas in all patients. In the second half of the study, enema was
4) Peritonitis: 5.7% ( 16 of 278 patients in Group A) compared
used on clinical suspicion of leakage due to the experience that
to 2.5% (7 of 275 patients in Group B); Peto OR 2.28, 95% CI:
two of the six leaks on day 7 after surgery occurred immediately
0.99 to 5.25) (p=0.05) - no statistical heterogeneity (Brownson
after administration of the routine water-soluble contrast enema.
1992, Fillmann 1995, Miettinen 2000, Tabusso 2002);
The contrast enema was used on clinical suspicion in four trials
5) Reoperation: 4.0% ( 16 of 393 patients in Group A) compared
(Burke 1994; Miettinen 2000; Santos 1994; Fillmann 1995).
to 2.2% (9 of 392 patients in Group B); Peto OR 1.80, 95%
For the diagnostics of the various outcomes, the trials:
CI: 0.81 to 3.98) (non-significant) - no statistical heterogeneity
a) did not describe the methodology (Brownson 1992, Bucher
(Bucher 2003 , Burke 1994 , Fillmann 1995 , Miettinen 2000 ,
2003, Tabusso 2002, Fa-Si-Oen 2003);
Santos 1994,Tabusso 2002);
b) used clinical symptoms and laboratory results (Burke 1994 ,
6) Wound infection: 7.4% (59 of 789 patients in Group A) com-
Santos 1994);
pared to 5.4% (43 of 803 patients in Group B); Peto OR 1.46, 95%
c) used laboratory results in patients in whom the clinical diagnosis
CI: 0.97 to 2.18 (p=0.07) - no statistical heterogeneity (Brownson
was unclear (Fillmann 1995);
1992, Bucher 2003, Burke 1994, Fillmann 1995, Miettinen 2000,
d) described all of the methods used for diagnosing the complica-
Santos 1994, Tabusso 2002, Zmora 2003);
tions (Miettinen 2000, Zmora 2003).
7) Infectious extra-abdominal complication: 8.3% ( 14 of 168
As stated in the beginning of this section, none of the studies used
patients in Group A) compared to 9.4% (15 of 159 patients in
an intention to treat analysis. Eight patients were excluded after
Group B); Peto OR, 95%: 0.87 (0.41 to 1.87) (non-significant) -
randomisation from one study (Santos 1994 ), 17 from another
no statistical heterogeneity (Fillmann 1995, Miettinen 2000);

8) Non-infectious extra-abdominal complication: 16.8% ( 73 of sions should be taken into consideration, when trying to answer
433 patients in Group A) compared to 16.1% (71 of 439 patients the question stated under ’objectives’.
in Group B); Peto OR 1.19, 95% CI: 0.61 to 2.32 (non-signifi-
We found no convincing evidence that mechanical bowel prepa-
cant) - no statistical heterogeneity (Burke 1994, Fillmann 1995,
ration before elective colorectal surgery reduces the incidence of
Miettinen 2000);
postoperative complications. When looking at the primary out-
9) Surgical site infection: 9.8% (31 of 325 patients in Group A)
come - anastomosis leakage - mechanical bowel preparation was
compared to 8.3% (27 of 322 patients in Group B); Peto OR
dangerous when looking at colorectal surgery as a whole (statis-
1.20, 95% CI: 0.70 to 2.05 (non-significant) - no statistical het-
tically significant result). The subgroup analyses did not alter the
erogeneity (Miettinen 2000, Zmora 2003);
direction of association, although the statistical significance disap-
SENSITIVITY ANALYSES:
peared.
Applying the random effects model in the only statistical signifi-
cant outcome still shows significant difference in favour of avoid- The outcome anastomosis leakage was split into leakage after low
ing cleansing. OR 2.09, CI: 1.16 to3.78, p =0.01. anterior resection and leakage after colonic surgery. It was only
10) Excluding the four studies where the allocation procedure was possible to obtain results from four authors (Burke 1994, Santos
considered unclear did not change the Peto OR substantially for 1994 , Miettinen 2000 , Zmora 2003 ). After this stratification,
the two clinical most important outcomes (anastomosis leakage the results tended to favour the group without mechanical bowel
and wound infection), although the significance disappeared due preparation.
to the smaller total the sample size (p = 0.1 and 0.14 respectively).
Some of the studies included patients in whom bowel continuity
11) Excluding the two studies only presented as abstracts substan-
was not restored when analysing the outcome anastomosis leakage
tially changed neither the Peto OR nor the level of significance for
(Tabusso 2002; Fillmann 1995; Santos 1994). Because the number
the two analysed outcomes.
of non-anastomotic patients were equally distributed between the
12) Excluding the study which included children did not change
groups so we do not feel this potential bias to be of significance.
the significant higher incidence of anastomotic leakage in the me-
chanical bowel preparation group, but the potential negative effect None of the studies included an intention to treat-analysis nor had
of cleansning on wound infection became smaller. any of the authors calculated the sample size before the study. Seven
13) Excluding the studies that included patients without anasto- of the studies must be considered underpowered from the begin-
mosis for the outcome anastomosis leakage, the Peto OR was 2.14 ning - only the Peruvian study (Tabusso 2002 ) showed its own
(p = 0.03) compared with the Peto OR of 2.29 (p = 0.002) before significance in favour of no cleansing. In this respect, the meta-
these studies were excluded. There was no substantially difference analysis is a good tool, and when there is no heterogeneity among
for the wound infection outcome. the studies the overall result can be accepted as valid. Allthough
no statistical heterogeneity was found between the outcomes of
the individual studies, some methodological and clinical hetero-
DISCUSSION geneity exists. Whether or not this should modify the conclusions
is debatable. We have tried with sensitivity-analysis to elucidate
In 1987 Irving (Irving 1987) questioned the efficacy of mechanical the consequences of the heterogeneity, and none of the analysis
bowel cleansing. The study was criticised by the editor (Johnston led to the conclusion that preparation would be of benefit for the
1987): “the paper which challenges accepted surgical practice, is a patient. The significance for the primary outcome although dis-
veritable little bomb of a paper, brief, iconoclastic, and disrespect- appers in some of the analyses, but the tendency is still strong,
ful of hallowed tradition in colorectal surgery”. At that time, the and always in the same direction - preparation might lead to more
mechanical bowel preparation was an incontestable routine - and anastomotic leakage. When performing the sensitivity-and sub-
still is according to guidelines from some surgical associations and group-analyses the reduced volume of material makes the analyses
scientific societies (ASCGBI 2001 ; Moore 1999 ; SIGN 1997 ), statistically underpowered. This increases the risk of a type II error
while other guidelines are now more up to date (Kronborg 2002). when evaluating the primary outcome. The Peto Odds Ratio re-
mains almost unchanged during the sensitivity-analyses although
The nine included trials were all prospective and randomised. Typ-
the significance disappears. This strongly supports the conclusion:
ically for studies of surgical practice, the allocation procedure was
Mechanical bowel cleansing leads to more anastomotic dehiscence
not very well described, but was considered adequate in half of
in colorectal surgery.
the studies. Most of the studies were performed before the im-
portance of allocation concealment (Schulz 1996) became general A stratified analysis between colonic and rectal surgery was only
knowledge. Only one of the studies tried to include some kind of feasible for four studies, and the results were inconclusive, although
blinding (Fillmann 1995) - an almost impossible task in trials of the tendency goes in the same direction as the overall results -
this kind. Despite these methodological flaws, the included stud- bowel preparation cannot be recommended in patients undergoing
ies must be considered of such a scientific value that their conclu- elective colorectal surgery.

Only one of the included trials evaluated the length of hospital AUTHORS’ CONCLUSIONS
stay (Tabusso 2002 ), and found that the group of patients that
Implications for practice
underwent mechanical bowel preparation had a longer hospital
stay than the other group of patients (statistically significant). It Prophylactic mechanical bowel preparation before colorectal
would be interesting to know how much time is needed to stay at surgery has not been proven valuable for patients. Controversially
the hospital before the surgery, just for the bowel to be cleaned. it seems that the preparation might lead to more anastomotic leak-
Analysing the types of interventions, from the table of included age and thus the procedure should be omitted.
studies, could provide some indication:
Implications for research
A) patients were prepared one day before surgery (Group A); the
The results of this systematic review show the necessity of complet-
patients of Group B have to be at the hospital in a few hours before
ing more trials addressing the safety and the clinical effectiveness
surgery (Brownson 1992, Burke 1994, Miettinen 2000);
of mechanical bowel preparation compared with no preparation
B) No difference due to the “doublle-blind” design, (Fillmann before elective colorectal surgery. Concealment of allocation is im-
1995); perative, especially as such a trial would probably require a multi-
centre design. Stratification between colonic and rectal surgery is
C) needed 5 days for Group A; and 1 day, for Group B (Santos
important. The use of pre-operative radiotherapy needs to be reg-
1994);
istered. Collaborative (properly designed) randomised controlled
D) patients were admitted to the hospital 48 hours before the trials that involve a large, representative number of individuals,
surgery (Tabusso 2002). See “Characteristics of included studies”. with explicit clinical inclusion and exclusion criteria, well defined
hospital discharge criteria, sufficient duration of follow-up, de-
In the protocol of the review, we discussed “length of hospital stay”
scription of dropouts and withdrawals, and uniform diagnosis of
as an outcome, but the trials did not describe this point clearly,
all relevant outcome measures should be planned.
and thus this outcome was excluded from the comparisons.
All included studies and almost all of the excluded studies used
prophylactic antibiotics in each group. This has raised the question ACKNOWLEDGEMENTS
of whether the antibiotic use could explain why no effect of the
mechanical bowel preparation was found. This review cannot give We want to thank the Cochrane Colorectal Cancer Group for
any substantial information on this matter. hosting one of the reviewers (KFG) for three weeks (November,
1999), to finish the review.
The results of this review do not show any benefit of performing
mechanical bowel preparations. A “semi prepared” colon is usually We also want to thank Dr. Zmora, Dr. Santos and Dr. Fillmann
full of liquid faeces that can be difficult to control, resulting in for supplying us with supplementary data.
spillage into the peritoneal cavity which can cause significant con-
Thanks to Mr. Henning K. Andersen and Mrs. Ina Fjeldmark for
tamination. By omitting mechanical preparation one overcomes
assisting with the review, and their special attention, when KFG
the problems of the poorly prepared bowel. The content of the
was in Copenhagen.
bowel (bulky stools) can be manipulated into the bowel segment
to be resected , enough to make the site of the anastomosis clear. The Valerie Jefferson Fund kindly supported this review financially
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trial. Br J Surg. 1992; Vol. 79:461–462.
Fa-Si-Oen 2003 {unpublished data only}
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∗
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Halsted 1887
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J Surg 1987;74:553–554.
Dorudi 1990 {published data only} Juni 2002
Dorudi S, Wilson NM, Heddle RM. [Primary restorative colectomy Juni P, Egger M. Allocation concealment in clinical trials. JAMA
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Duthie GS, Foster ME, Price-Thomas JM, Leaper DJ. [Bowel prepa- drup P, Harling H, Jakobsen A, Nejer J, FengerC. Guidelines
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Irving AD, Scrimgeour D. [Mechanical bowel preparation for colonic Moore 1999
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581. ment of colonic cancer I: surgical issues. Recommendations of the
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Keighley MRB. [Randomized multicentre trial of oral bowel prepara- Nichols 1971
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of Surgery 1978;65(9):597–600. Gynecol Obstet 1971;2:323–337.

O’Dwyer 1989 Smith 1983
O’Dwyer PJ, Conway W, McDermott EWM, O’Higgins NJ. Effect Smith SRG, Connolly JC, Gilmore OJA. The effect of faecal loading
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low anterior resection in dogs. Br J Surg 1989;76:756–8. Thornton 1997
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SIGN 1997 Guenaga 2002
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Indicates the major publication for the study
CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Brownson 1992
Methods Randomisation, blinding, follow-up, withdrawal and dropout: no details.

Participants Inclusion criteria: patients undergoing elective colorectal surgery. Exclusion criteria: no details. Diseases:
colorectal cancer: 164/179; other: 14/179.
Number of participants: 179. Age: no details. Location of study: Liverpool, UK. Antibiotcs: perioperative
intravenous (no more details).
Interventions A: Mechanical bowel preparation (n=86)
B: No preparation (n=93)
Outcomes Wound infection:
A=5/86, B=7/93
Intra-abdominal sepsis: A=8/86, B=2/93
Anastomic leakage:
A:8/67*, B:1/67*
*Patients whom bowel continuity was restored.
Notes Only conference procreeding - never published as article, results obtained from abstract.
Risk of bias

Brownson 1992
(Continued )
Item Authors’ judgement Description
Allocation concealment? Unclear B - Unclear
Bucher 2003
Methods Randomisation and blinding: no details

Participants Elective left-sided colorectal surgery
Interventions A: Mechanical Bowel Preparation, 3 litres Polyethylene glycol (N=47)
B: No preparation, (N = 46)
Outcomes Anastomotic leakage and wound infection
Notes Conference proceeding.
Risk of bias
Burke 1994
Methods Randomisation: no details.

Blinding: single-blind: surgeons was aware of the patient’s bowel preparation.
c) Withdrawal/dropout: 31% (17/186 cases) was withdrawed / no dropout.
d) Follow-up: 07 days after surgery (unclear).
Participants Inclusion criteria: patients admitted for elective colorectal surgery with primary anastomosis.
Exclusion criteria: any patients who could not tolerate the preparation; patients who had had the bowel
’prepared’ for another procedure within previous week.
Diagnoses: 72% colorectal cancer (133/186 cases); 3% inflammatory bowel disease (6/186 cases); 14%
diverticular disease (26/186 cases); 2% other (4/186 cases).
Number: 186 (95 male; 74 female; 17 undetermined).
Age: mean 64 years.
Location of study: Dublin, Ireland.
Time: October, 1988 - September, 1992.
Antibiotics: Ceftriaxone 1 gr and metronidazole 500 mg intravenously starting at induction of anaesthesia.
Metronidazole 500 mg: 8 and 16 h, after initial dosis.
Interventions a) Mechanical bowel preparation group (n = 82): sodium picosulphate 10 mg, the day before surgery (dose
at morning and afternoon).
b) Group B (n= 87): a normal diet and no other bowel preparation.

Burke 1994
(Continued )
Outcomes a) Death: A=2; B=0.
b) Cardiorespiratory: A=8; B=9.
c) Wound infection: A=4; B=3.
d) Anastomotic dehiscence: A=3; B=4.
e) Reoperation: A=2; B=4.
Notes Representative sample: consecutive patients.
Surgeries procedures that were excluded: patients submitted a Hartman’s resection (5:5); de functioning
colostomy (0:2); abdominal excision of the rectum (1:2); coloanal anastomosis with colostomy (0:1);
colotomy for rectal polyp (1:0).
All surgery was performed by one of two consultant surgeons or a senior registrar.
Excluded patients without anastomosis.
Reccurrence because the leakage.
Left colectomy: A=26; B=28.
Anterior resection: A=56; B=59.
Anastomotic leakage/low anterior resection: A=3/39; B=4/36.
Risk of bias
Fa-Si-Oen 2003
Methods Unknown
Participants Colorectal Surgery
Interventions A) Mechanical Bowel Preparation - Polyethylene glycol
B: No cleansing
Outcomes Anastomotic leakage, Wound Infection
Notes Secondary data from another metaanalysis
Risk of bias
Fillmann 1995
Methods Randomization: no details.

Blinding: double-blind (orange juice for the control group; no details on blinding of the surgeons.
Fillmann 1995
(Continued )
Withdrawal/dropout: no withdrawal and dropout.
Follow-up: 30 days after surgery.
Participants Inclusion criteria: patients admitted for elective colorectal surgery with primary anastomosis.
Exclusion criteria: no exclusions.
Diseases: colorectal cancer (21:22); diverticular disease (05:06); inflammatory bowel disease (02:02);
Chron disease (01:00); ischaemic colitis (00:01).
Number: 60 (33 male; 27 female).
Age: 31-82 years.
Location: Porto Alegre, RS - Brazil.
Time: 1992-1993.Antibiotics: metronidazole + gentamicin 1 hour before surgery, and during 48 hours.
Interventions Group A -Mechanical bowel preparation (n= 30): 500 ml manitol 20% + 500 ml orange juice.
Group B (n= 30): orange juice.
Outcomes Wound infection: A=1; B=2.
Peritonitis: A=2; B=1.
Extra-abdominal complications (non-infections):-Mechanical obstruction: A=0; B=1.-Dehiscence of
wall suture: A=0; B=1. -Pulmonary embolism: A=1; B=0.Extra-abdominal complications (infections):-
Pneumonia: A=1; B=1.- Urinary infection: A=1; B=2.
Notes The sample size was calculated, but no more details.
Included patients without anastomosis.
Recurrence was not mentioned.
No death reported in this trial.
Risk of bias
Allocation concealment? Yes A - Adequate
Miettinen 2000
Methods Randomization: sealed envelopes; consecutive adult patients.

Blinding: not described.
Withdrawal/dropout: all the patients completed the study.
Follow-up: 1-2 months after surgery.
Participants Inclusion criteria: all consecutive adults admitted for elective colorectal surgery.
Exclusion criteria: patients who had had bowel preparation for colonoscopy one week before surgery (n=5);
patients who where unable to drink PEG-ELS (n=2); patients not requiring opening of the bowel (n=4);
patient who refused to be randomised (n=1).
Disease: colorectal cancer (134/267); benign tumours (24/267); inflammatory bowel disease (32/267);
diverticular disease (58/267); other (19/267).Number: 267 (130 male; 137 female).Age: 16-97
years.Location: Kuopio + Oulu, Finland.Time: 1994-1996.Antibiotics: ceftriaxone 2 gr + metronidazole 1
gr at the induction of anaesthesia.
Interventions Group A - Mechanical bowel preparation (n=138): Polyethylene glycol electrolyte solution, and no solid
Miettinen 2000
(Continued )
food on the preoperative day.
Group B (n=129): no preparations and normal diet.

Anastomotic leakage: A=5; B=3.
Abdominal abscess: A=3; B=4.
Non-infection postoperative complication: A=11; B=6.
Reoperation: A=4; B=2.
Extra-abdominal infections: A=4; B=2.
Postoperative stay (range/days): A=8; B=8.
Operation time (range/min): A=120; B=110.
Notes Low colonic anastomosis/Leakage: A = 9/3; B = 14/2.
Patients with pre-existing disease: A=48; B=61.
The differences between the two groups were not significant.
All surgery was carried out by a specialist or by a junior surgeon assisted by a specialist.
Excluded patients without anastomosis.
Abdominal abscess: treated conservatively.
Re-operation (total:7/3 ??):
- wound rupture: A=2; B=0;
- perfuration of the gallbladder: A=1; B=0;
- techinical anastomotic failure: A=0; B=1;
- small bowel occlusions: A=1; B=2.
Reoccurrence was because the leakage.
No death in this trial.
Risk of bias
Santos 1994
Methods Randomisation: patients were allocated by randomised cards.

Blinding: not described.
Withdrawal/dropout: 5% (8/157 cases) was withdrawn / no dropout.
Follow-up: 30 days or until hospital discharge.
Participants Inclusion criteria: Patients admitted for elective colorectal surgery.
Exclusion criteria: patients that had taken antibiotics for at least 15 days before surgery or if there
was evidence of infection or any associated disease requiring antibiotic therapy; and patients that the
mechanical bowel preparation was not feasible.
Group A: 5 patients were excluded: associated infectious disease (2 patients), and failure to achieve full
mechanical bowel preparation (3 patients).
Group B: 3 patients excluded: an intra-abdominal foreign body found during the operation (1 patient),
and urinary tract infection (2 patients).
Diseases: 43% colorectal cancer (68/157); 34% megacolon (53/157); 6% inflammatory bowel disease
Santos 1994
(Continued )
(9/157); 3% diverticular disease (5/157); 2% familial adenoma polyposis (3/157); 7% other (11/157).
Number: 157 (72 male; 77 female; 8 undetermined).
Age: 1 - 93 years.
Location: Ribeirão Preto, São Paulo - Brazil.
Time: October, 1991 - December, 1992.
Antibiotics: Cephalothin 2 gr and metronidazole 1 g intravenously at 2 h before induction of anaesthesia.
Cephalothin 1 gr was given 6 and 12 h, and metronidazole 500 mg, 8 and 16 h after the initial dose.
Interventions Group A - Mechanical bowel preparation (n= 72):

LAXATIVE (mineral oil, agar and phenolphthalein) 15 ml taken by mouth three times a day for 5 days
before surgery; mannitol (1 litre as a 10% solution) taken by mouth at the rate of 100 ml per 5 min at
16:00 hours on the day before surgery.
ENEMA (water, 900 ml; glycerin, 100 ml) given once a day for 2 days before surgery.
children : enema of water and glycerin (9:1) twice a day for 2 days before surgery.
Group B (n= 77): a low-reside diet and no other mechanical bowel preparation.
Outcomes Wound infection: A=17; B=9. Anastomotic dehiscence: A=7; B=4.
Hospital stay (preoperative): A=2-34; B=0-90. Reoperation: A=4; B=1.
Microbiology (bacteria isolated):
-Bowel content: A=211/62; B=261/72.
-Peritoneal fluid: A=116/62; B=134/72.
-Wounds: A=38/17; B=17/7.
Notes Not described the representative sample.
Patients/Associated medical problems: A=53/75; B=52/78.
Associated medical disease: A=17; B=7.
Patients with complications: A=21 (7+17=?); B=11 (4+9=?).
Most of the patients were operated on by a senior resident (not the consultant).
Included patients without anastomosis.
Reoccurrence was because the leakage.
No death in this trial.
Risk of bias
Tabusso 2002
Methods Randomisation, blinding, withdrawal and dropout: no details. Follow-up: until hospital discharged (not
described).
Participants Inclusion criteria: pacients with colorectal cancer, submitted an elective colorectal surgery . Exclusion
criteria: no details. Diseases: colorectal cancer. Participantes: 47 (21 male, 26 female). Age: 22 - 87.
Location of study: Lima, Peru. Time: october 1999 - january 2001. Antibiotcs: against anaerobic and Gran
negative bacteria, intravenous, 30 minutes before surgery.
Interventions Group A - Mechanical bowel preparation (n=24): mannitol or polyethylene glycol electrolyte solution +
Tabusso 2002
(Continued )
liquid diet 48 hours before surgery.
Group B - No mechanical bowel preparation (n=23): liquid diet 48 hours before surgery.

Anastomotic leakage: A=5; B=0.
Peritonitis: A=3; B=0.
Notes Length of hospital stay: A=17-19 (14); B=6-15 (11). Analysed only the complications related with the
surgery. Patients without anastomosis (2 patients in A; 3 patients in B).
Risk of bias
Zmora 2003
Methods Randomisation: Computer generated.

Follow-up after 30 days
Participants Inclusion criteria:
Pateints admitted for elective colon and rectal surgery
Exclusion criteria:
Not described
Interventions Group A -
Mechanical bowel preparation (n= 187) with polyethylene glycol
Group B -
No preparation (n= 193)
Outcomes Overall Infection:
A=19; B=17.
Wound Infection:
A=12; B=11.
Anastomotic leak:
A=7; B=2
Intraabdominal Abscess:
A=2, B=2
Notes All anastomises were “left-sided”
Extra data after stratification has been obtained
Risk of bias

Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion

Dorudi 1990 None
Duthie 1990 The study is a survey.
Without control group.
Hughes 1972 First data as a conference proceedings.
Most of the data are unclear.
The author did not reply to our enquiries, to complete the review.
Irving 1987 Without control group.
Matheson 1978 Testing antimicrobials.
The control group receive elemental diet.
Memon 1997 A retropective and non-randomized study.

DATA AND ANALYSES
Comparison 1. Mechanical bowel preparation versus no preparation
No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size
1 Anastomosis leakage stratified Peto Odds Ratio (Peto, Fixed, 95% CI) Subtotals only
for colonic or rectal surgery
1.1 Leakage after low anterior 4 231 Peto Odds Ratio (Peto, Fixed, 95% CI) 1.45 [0.57, 3.67]
resection
1.2 Leakage after colonic 4 734 Peto Odds Ratio (Peto, Fixed, 95% CI) 1.80 [0.68, 4.75]
surgery
2 Overall anastomotic leakage for 9 1549 Peto Odds Ratio (Peto, Fixed, 95% CI) 2.03 [1.27, 3.26]
colorectal surgery
3 Mortality 5 1025 Peto Odds Ratio (Peto, Fixed, 95% CI) 1.72 [0.43, 6.95]
4 Peritonitis 4 553 Peto Odds Ratio (Peto, Fixed, 95% CI) 2.28 [0.99, 5.25]
5 Reoperation 6 785 Peto Odds Ratio (Peto, Fixed, 95% CI) 1.80 [0.81, 3.98]
6 Wound infection 9 1594 Peto Odds Ratio (Peto, Fixed, 95% CI) 1.45 [0.97, 2.18]
7 Infectious extra-abdominal 2 327 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.87 [0.41, 1.87]
complications
8 Non-infectious extra-abdominal 4 872 Peto Odds Ratio (Peto, Fixed, 95% CI) 1.09 [0.75, 1.58]
complications
9 Surgical site infections 2 647 Peto Odds Ratio (Peto, Fixed, 95% CI) 1.20 [0.70, 2.04]
10 Sensitivity analysis 1 - Studies Peto Odds Ratio (Peto, Fixed, 95% CI) Subtotals only
with dubious randomisation
procedure excluded
10.1 Overall anastomotic 4 856 Peto Odds Ratio (Peto, Fixed, 95% CI) 1.80 [0.90, 3.61]
leakage for colorectal surgery
10.2 Wound infection 4 856 Peto Odds Ratio (Peto, Fixed, 95% CI) 1.50 [0.88, 2.56]
published as abstract only
excluded
11.1 Anastomotic leakage 6 1072 Peto Odds Ratio (Peto, Fixed, 95% CI) 1.86 [1.03, 3.39]
including children excluded
12.1 Anastomotic leakage 7 1150 Peto Odds Ratio (Peto, Fixed, 95% CI) 2.38 [1.34, 4.25]
13 Sensitivity analysis 4 - Studies Odds Ratio (M-H, Fixed, 95% CI) Subtotals only
including patients without
anastomosis excluded
13.1 Anastomosis leakage 5 1043 Odds Ratio (M-H, Fixed, 95% CI) 2.14 [1.09, 4.19]
13.2 Wound infection 5 1088 Odds Ratio (M-H, Fixed, 95% CI) 1.25 [0.72, 2.15]

Analysis 1.1. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 1 Anastomosis
leakage stratified for colonic or rectal surgery.
Review: Mechanical bowel preparation for elective colorectal surgery
Comparison: 1 Mechanical bowel preparation versus no preparation
Outcome: 1 Anastomosis leakage stratified for colonic or rectal surgery
Study or subgroup Preparation No preparation Peto Odds Ratio Weight Peto Odds Ratio
n/N n/N Peto,Fixed,95% CI Peto,Fixed,95% CI
1 Leakage after low anterior resection

Burke 1994 3/39 4/36 36.0 % 0.67 [ 0.14, 3.15 ]
Miettinen 2000 3/9 2/14 21.9 % 2.92 [ 0.40, 21.25 ]
Santos 1994 2/21 2/29 20.5 % 1.42 [ 0.18, 11.01 ]
Zmora 2003 3/43 1/40 21.6 % 2.62 [ 0.36, 19.34 ]
Subtotal (95% CI) 112 119 100.0 % 1.45 [ 0.57, 3.67 ]

Total events: 11 (Preparation), 9 (No preparation)
Heterogeneity: Chi2 = 1.77, df = 3 (P = 0.62); I2 =0.0%
Test for overall effect: Z = 0.78 (P = 0.43)
2 Leakage after colonic surgery
Burke 1994 0/43 0/51 0.0 % Not estimable
Miettinen 2000 2/129 1/115 18.1 % 1.75 [ 0.18, 17.02 ]
Santos 1994 5/51 2/48 40.1 % 2.34 [ 0.51, 10.80 ]
Zmora 2003 4/144 3/153 41.8 % 1.42 [ 0.32, 6.37 ]
Subtotal (95% CI) 367 367 100.0 % 1.80 [ 0.68, 4.75 ]

Test for subgroup differences: Chi2 = 0.10, df = 1 (P = 0.75), I2 =0.0%
0.01 0.1 1 10 100

Favors preparation Favors control

Study or subgroup Preparation No preparation Peto Odds Ratio Peto Odds Ratio
1 Leakage after low anterior resection

Burke 1994 3/39 4/36 0.67 [ 0.14, 3.15 ]
Miettinen 2000 3/9 2/14 2.92 [ 0.40, 21.25 ]
Santos 1994 2/21 2/29 1.42 [ 0.18, 11.01 ]
Zmora 2003 3/43 1/40 2.62 [ 0.36, 19.34 ]
Subtotal (95% CI) 112 119 1.45 [ 0.57, 3.67 ]

0.01 0.1 1 10 100


Study or subgroup Preparation No preparation Peto Odds Ratio Peto Odds Ratio
2 Leakage after colonic surgery

Burke 1994 0/43 0/51 Not estimable
Miettinen 2000 2/129 1/115 1.75 [ 0.18, 17.02 ]
Santos 1994 5/51 2/48 2.34 [ 0.51, 10.80 ]
Zmora 2003 4/144 3/153 1.42 [ 0.32, 6.37 ]
Subtotal (95% CI) 367 367 1.80 [ 0.68, 4.75 ]

0.01 0.1 1 10 100


Analysis 1.2. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 2 Overall
anastomotic leakage for colorectal surgery.
Outcome: 2 Overall anastomotic leakage for colorectal surgery
Brownson 1992 8/67 1/67 12.3 % 5.23 [ 1.36, 20.14 ]
Bucher 2003 4/47 1/46 7.0 % 3.43 [ 0.57, 20.59 ]
Burke 1994 3/82 4/87 9.8 % 0.79 [ 0.17, 3.58 ]
Fa-Si-Oen 2003 7/125 6/125 18.0 % 1.18 [ 0.39, 3.58 ]
Fillmann 1995 2/30 1/30 4.2 % 1.99 [ 0.20, 19.94 ]
Miettinen 2000 5/138 3/129 11.3 % 1.56 [ 0.38, 6.36 ]
Santos 1994 7/72 4/77 14.9 % 1.93 [ 0.57, 6.57 ]
Tabusso 2002 5/24 0/23 6.7 % 8.54 [ 1.36, 53.51 ]
Zmora 2003 7/187 4/193 15.6 % 1.81 [ 0.55, 5.99 ]
Total (95% CI) 772 777 100.0 % 2.03 [ 1.27, 3.26 ]

0.01 0.1 1 10 100


Analysis 1.3. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 3 Mortality.
Outcome: 3 Mortality
Burke 1994 2/82 0/87 25.1 % 7.95 [ 0.49, 128.33 ]
Fillmann 1995 0/30 0/30 0.0 % Not estimable
Miettinen 2000 0/138 0/129 0.0 % Not estimable
Santos 1994 0/72 0/77 0.0 % Not estimable
Zmora 2003 3/187 3/193 74.9 % 1.03 [ 0.21, 5.17 ]
Total (95% CI) 509 516 100.0 % 1.72 [ 0.43, 6.95 ]

Heterogeneity: Chi2 = 1.55, df = 1 (P = 0.21); I2 =35%
0.01 0.1 1 10 100

Favours preparation Favours control
Analysis 1.4. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 4 Peritonitis.
Outcome: 4 Peritonitis
Brownson 1992 8/86 2/93 42.9 % 3.85 [ 1.08, 13.76 ]
Fillmann 1995 2/30 1/30 13.1 % 1.99 [ 0.20, 19.94 ]
Miettinen 2000 3/138 4/129 31.0 % 0.70 [ 0.16, 3.12 ]
Tabusso 2002 3/24 0/23 13.0 % 7.75 [ 0.77, 78.41 ]
Total (95% CI) 278 275 100.0 % 2.28 [ 0.99, 5.25 ]

Heterogeneity: Chi2 = 4.14, df = 3 (P = 0.25); I2 =28%
0.01 0.1 1 10 100


Analysis 1.5. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 5 Reoperation.
Outcome: 5 Reoperation
Bucher 2003 5/47 1/46 23.4 % 4.00 [ 0.77, 20.76 ]
Burke 1994 2/82 4/87 24.0 % 0.53 [ 0.11, 2.71 ]
Fillmann 1995 1/30 1/30 8.1 % 1.00 [ 0.06, 16.37 ]
Miettinen 2000 4/138 2/129 24.3 % 1.84 [ 0.37, 9.28 ]
Santos 1994 4/72 1/77 20.1 % 3.68 [ 0.62, 21.80 ]
Tabusso 2002 0/24 0/23 0.0 % Not estimable
Total (95% CI) 393 392 100.0 % 1.80 [ 0.81, 3.98 ]

0.01 0.1 1 10 100

Analysis 1.6. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 6 Wound
infection.
Outcome: 6 Wound infection
Brownson 1992 5/86 7/93 12.0 % 0.76 [ 0.24, 2.45 ]
Bucher 2003 4/47 1/46 5.1 % 3.43 [ 0.57, 20.59 ]
Burke 1994 4/82 3/87 7.2 % 1.43 [ 0.32, 6.47 ]
Fa-Si-Oen 2003 9/125 7/125 16.1 % 1.30 [ 0.47, 3.59 ]
Fillmann 1995 1/30 2/30 3.1 % 0.50 [ 0.05, 5.02 ]
Miettinen 2000 5/138 3/129 8.3 % 1.56 [ 0.38, 6.36 ]
Santos 1994 17/72 9/77 23.0 % 2.28 [ 0.98, 5.29 ]
Tabusso 2002 2/24 0/23 2.1 % 7.40 [ 0.45, 122.11 ]
0.01 0.1 1 10 100

Favors preparation Favors control (Continued . . . )

(. . . Continued)
Zmora 2003 12/187 11/193 23.1 % 1.13 [ 0.49, 2.63 ]
Total (95% CI) 791 803 100.0 % 1.45 [ 0.97, 2.18 ]

0.01 0.1 1 10 100

Analysis 1.7. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 7 Infectious
extra-abdominal complications.
Outcome: 7 Infectious extra-abdominal complications
Fillmann 1995 2/30 3/30 17.5 % 0.65 [ 0.11, 4.00 ]
Miettinen 2000 12/138 12/129 82.5 % 0.93 [ 0.40, 2.15 ]
Total (95% CI) 168 159 100.0 % 0.87 [ 0.41, 1.87 ]

0.01 0.1 1 10 100


Analysis 1.8. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 8 Non-
infectious extra-abdominal complications.
Outcome: 8 Non-infectious extra-abdominal complications
Burke 1994 8/82 9/87 13.9 % 0.94 [ 0.34, 2.55 ]
Fillmann 1995 1/30 2/30 2.6 % 0.50 [ 0.05, 5.02 ]
Miettinen 2000 11/138 6/129 14.4 % 1.74 [ 0.65, 4.65 ]
Zmora 2003 53/183 54/193 69.1 % 1.05 [ 0.67, 1.64 ]
Total (95% CI) 433 439 100.0 % 1.09 [ 0.75, 1.58 ]

0.01 0.1 1 10 100

Analysis 1.9. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 9 Surgical site
infections.
Outcome: 9 Surgical site infections
Miettinen 2000 13/138 10/129 39.2 % 1.24 [ 0.53, 2.90 ]
Zmora 2003 19/187 17/193 60.8 % 1.17 [ 0.59, 2.32 ]
Total (95% CI) 325 322 100.0 % 1.20 [ 0.70, 2.04 ]

0.2 0.5 1 2 5

Analysis 1.10. Comparison 1 Mechanical bowel preparation versus no preparation, Outcome 10 Sensitivity
analysis 1 - Studies with dubious randomisation procedure excluded.
Outcome: 10 Sensitivity analysis 1 - Studies with dubious randomisation procedure excluded
Study or subgroup Preparation No Preparation Peto Odds Ratio Weight Peto Odds Ratio
1 Overall anastomotic leakage for colorectal surgery

Fillmann 1995 2/30 1/30 9.2 % 1.99 [ 0.20, 19.94 ]
Miettinen 2000 5/138 3/129 24.6 % 1.56 [ 0.38, 6.36 ]
Santos 1994 7/72 4/77 32.4 % 1.93 [ 0.57, 6.57 ]
Zmora 2003 7/187 4/193 33.8 % 1.81 [ 0.55, 5.99 ]
Subtotal (95% CI) 427 429 100.0 % 1.80 [ 0.90, 3.61 ]

Total events: 21 (Preparation), 12 (No Preparation)
2 Wound infection
Fillmann 1995 1/30 2/30 5.4 % 0.50 [ 0.05, 5.02 ]
Miettinen 2000 5/138 3/129 14.4 % 1.56 [ 0.38, 6.36 ]
Santos 1994 17/72 9/77 40.0 % 2.28 [ 0.98, 5.29 ]
Zmora 2003 12/187 11/193 40.2 % 1.13 [ 0.49, 2.63 ]
Subtotal (95% CI) 427 429 100.0 % 1.50 [ 0.88, 2.56 ]

0.2 0.5 1 2 5

Study or subgroup Preparation No Preparation Peto Odds Ratio Peto Odds Ratio
1 Overall anastomotic leakage for colorectal surgery

Fillmann 1995 2/30 1/30 1.99 [ 0.20, 19.94 ]
Miettinen 2000 5/138 3/129 1.56 [ 0.38, 6.36 ]
Santos 1994 7/72 4/77 1.93 [ 0.57, 6.57 ]
Zmora 2003 7/187 4/193 1.81 [ 0.55, 5.99 ]
Subtotal (95% CI) 427 429 1.80 [ 0.90, 3.61 ]

0.2 0.5 1 2 5

2 Wound infection
Fillmann 1995 1/30 2/30 0.50 [ 0.05, 5.02 ]
Miettinen 2000 5/138 3/129 1.56 [ 0.38, 6.36 ]
Santos 1994 17/72 9/77 2.28 [ 0.98, 5.29 ]
Zmora 2003 12/187 11/193 1.13 [ 0.49, 2.63 ]
Subtotal (95% CI) 427 429 1.50 [ 0.88, 2.56 ]

0.2 0.5 1 2 5

analysis 2 - Studies published as abstract only excluded.
Outcome: 11 Sensitivity analysis 2 - Studies published as abstract only excluded
Study or subgroup Preparation No Preparation Peto Odds Ratio Weight Peto Odds Ratio
1 Anastomotic leakage
Burke 1994 3/82 4/87 15.7 % 0.79 [ 0.17, 3.58 ]
Fillmann 1995 2/30 1/30 6.7 % 1.99 [ 0.20, 19.94 ]
Miettinen 2000 5/138 3/129 18.1 % 1.56 [ 0.38, 6.36 ]
Santos 1994 7/72 4/77 23.9 % 1.93 [ 0.57, 6.57 ]
Tabusso 2002 5/24 0/23 10.6 % 8.54 [ 1.36, 53.51 ]
Zmora 2003 7/187 4/193 24.9 % 1.81 [ 0.55, 5.99 ]
Subtotal (95% CI) 533 539 100.0 % 1.86 [ 1.03, 3.39 ]

2 Wound infection
Burke 1994 4/82 3/87 10.8 % 1.43 [ 0.32, 6.47 ]
Fillmann 1995 1/30 2/30 4.6 % 0.50 [ 0.05, 5.02 ]
Miettinen 2000 5/138 3/129 12.4 % 1.56 [ 0.38, 6.36 ]
Santos 1994 17/72 9/77 34.5 % 2.28 [ 0.98, 5.29 ]
Tabusso 2002 2/24 0/23 3.1 % 7.40 [ 0.45, 122.11 ]
Zmora 2003 12/187 11/193 34.6 % 1.13 [ 0.49, 2.63 ]
Subtotal (95% CI) 533 539 100.0 % 1.57 [ 0.96, 2.58 ]

0.2 0.5 1 2 5

Burke 1994 3/82 4/87 0.79 [ 0.17, 3.58 ]
Fillmann 1995 2/30 1/30 1.99 [ 0.20, 19.94 ]
Miettinen 2000 5/138 3/129 1.56 [ 0.38, 6.36 ]
Santos 1994 7/72 4/77 1.93 [ 0.57, 6.57 ]
Tabusso 2002 5/24 0/23 8.54 [ 1.36, 53.51 ]
Zmora 2003 7/187 4/193 1.81 [ 0.55, 5.99 ]
Subtotal (95% CI) 533 539 1.86 [ 1.03, 3.39 ]

0.2 0.5 1 2 5

2 Wound infection
Burke 1994 4/82 3/87 1.43 [ 0.32, 6.47 ]
Fillmann 1995 1/30 2/30 0.50 [ 0.05, 5.02 ]
Miettinen 2000 5/138 3/129 1.56 [ 0.38, 6.36 ]
Santos 1994 17/72 9/77 2.28 [ 0.98, 5.29 ]
Tabusso 2002 2/24 0/23 7.40 [ 0.45, 122.11 ]
Zmora 2003 12/187 11/193 1.13 [ 0.49, 2.63 ]
Subtotal (95% CI) 533 539 1.57 [ 0.96, 2.58 ]

0.2 0.5 1 2 5

analysis 3 - Studies including children excluded.
Outcome: 12 Sensitivity analysis 3 - Studies including children excluded
Study or subgroup Favours preparation Favours control Peto Odds Ratio Weight Peto Odds Ratio
Brownson 1992 8/67 1/67 18.4 % 5.23 [ 1.36, 20.14 ]
Bucher 2003 4/47 1/46 10.4 % 3.43 [ 0.57, 20.59 ]
Burke 1994 3/82 4/87 14.7 % 0.79 [ 0.17, 3.58 ]
Fillmann 1995 2/30 1/30 6.3 % 1.99 [ 0.20, 19.94 ]
Miettinen 2000 5/138 3/129 16.9 % 1.56 [ 0.38, 6.36 ]
Tabusso 2002 5/24 0/23 9.9 % 8.54 [ 1.36, 53.51 ]
Zmora 2003 7/187 4/193 23.3 % 1.81 [ 0.55, 5.99 ]
Subtotal (95% CI) 575 575 100.0 % 2.38 [ 1.34, 4.25 ]

Total events: 34 (Favours preparation), 14 (Favours control)
2 Wound infection
Brownson 1992 5/86 7/93 19.7 % 0.76 [ 0.24, 2.45 ]
Bucher 2003 4/47 1/46 8.4 % 3.43 [ 0.57, 20.59 ]
Burke 1994 4/82 3/87 11.8 % 1.43 [ 0.32, 6.47 ]
Fillmann 1995 1/30 2/30 5.1 % 0.50 [ 0.05, 5.02 ]
Miettinen 2000 5/138 3/129 13.6 % 1.56 [ 0.38, 6.36 ]
Tabusso 2002 2/24 0/23 3.4 % 7.40 [ 0.45, 122.11 ]
Zmora 2003 12/187 11/193 38.0 % 1.13 [ 0.49, 2.63 ]
Subtotal (95% CI) 594 601 100.0 % 1.26 [ 0.75, 2.12 ]

Test for subgroup differences: Chi2 = 2.56, df = 1 (P = 0.11), I2 =61%
0.2 0.5 1 2 5
Favours treatment Favours control

Study or subgroup Favours preparation Favours control Peto Odds Ratio Peto Odds Ratio
Brownson 1992 8/67 1/67 5.23 [ 1.36, 20.14 ]
Bucher 2003 4/47 1/46 3.43 [ 0.57, 20.59 ]
Burke 1994 3/82 4/87 0.79 [ 0.17, 3.58 ]
Fillmann 1995 2/30 1/30 1.99 [ 0.20, 19.94 ]
Miettinen 2000 5/138 3/129 1.56 [ 0.38, 6.36 ]
Tabusso 2002 5/24 0/23 8.54 [ 1.36, 53.51 ]
Zmora 2003 7/187 4/193 1.81 [ 0.55, 5.99 ]
Subtotal (95% CI) 575 575 2.38 [ 1.34, 4.25 ]

0.2 0.5 1 2 5

2 Wound infection
Brownson 1992 5/86 7/93 0.76 [ 0.24, 2.45 ]
Bucher 2003 4/47 1/46 3.43 [ 0.57, 20.59 ]
Burke 1994 4/82 3/87 1.43 [ 0.32, 6.47 ]
Fillmann 1995 1/30 2/30 0.50 [ 0.05, 5.02 ]
Miettinen 2000 5/138 3/129 1.56 [ 0.38, 6.36 ]
Tabusso 2002 2/24 0/23 7.40 [ 0.45, 122.11 ]
Zmora 2003 12/187 11/193 1.13 [ 0.49, 2.63 ]
0.2 0.5 1 2 5
Favours treatment Favours control (Continued . . . )

(. . . Continued)
Subtotal (95% CI) 594 601 1.26 [ 0.75, 2.12 ]
0.2 0.5 1 2 5
analysis 4 - Studies including patients without anastomosis excluded.
Outcome: 13 Sensitivity analysis 4 - Studies including patients without anastomosis excluded
Study or subgroup Treatment Control Odds Ratio Weight Odds Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
1 Anastomosis leakage
Brownson 1992 8/67 1/67 7.1 % 8.95 [ 1.09, 73.69 ]
Bucher 2003 4/47 1/46 7.5 % 4.19 [ 0.45, 38.96 ]
Burke 1994 3/82 4/87 30.3 % 0.79 [ 0.17, 3.63 ]
Miettinen 2000 5/138 3/129 24.3 % 1.58 [ 0.37, 6.74 ]
Zmora 2003 7/187 4/193 30.8 % 1.84 [ 0.53, 6.38 ]
Subtotal (95% CI) 521 522 100.0 % 2.14 [ 1.09, 4.19 ]

Total events: 27 (Treatment), 13 (Control)
2 Wound infection
Brownson 1992 5/86 7/93 27.4 % 0.76 [ 0.23, 2.49 ]
Bucher 2003 4/47 1/46 4.0 % 4.19 [ 0.45, 38.96 ]
Burke 1994 4/82 3/87 12.0 % 1.44 [ 0.31, 6.62 ]
Miettinen 2000 5/138 3/129 12.9 % 1.58 [ 0.37, 6.74 ]
Zmora 2003 12/187 11/193 43.8 % 1.13 [ 0.49, 2.64 ]
Subtotal (95% CI) 540 548 100.0 % 1.25 [ 0.72, 2.15 ]

0.2 0.5 1 2 5

Study or subgroup Treatment Control Odds Ratio Odds Ratio

1 Anastomosis leakage
Brownson 1992 8/67 1/67 8.95 [ 1.09, 73.69 ]
Bucher 2003 4/47 1/46 4.19 [ 0.45, 38.96 ]
Burke 1994 3/82 4/87 0.79 [ 0.17, 3.63 ]
Miettinen 2000 5/138 3/129 1.58 [ 0.37, 6.74 ]
Zmora 2003 7/187 4/193 1.84 [ 0.53, 6.38 ]
Subtotal (95% CI) 521 522 2.14 [ 1.09, 4.19 ]

0.2 0.5 1 2 5

Study or subgroup Treatment Control Odds Ratio Odds Ratio

2 Wound infection
Brownson 1992 5/86 7/93 0.76 [ 0.23, 2.49 ]
Bucher 2003 4/47 1/46 4.19 [ 0.45, 38.96 ]
Burke 1994 4/82 3/87 1.44 [ 0.31, 6.62 ]
Miettinen 2000 5/138 3/129 1.58 [ 0.37, 6.74 ]
Zmora 2003 12/187 11/193 1.13 [ 0.49, 2.64 ]
Subtotal (95% CI) 540 548 1.25 [ 0.72, 2.15 ]

0.2 0.5 1 2 5
WHAT’S NEW
Last assessed as up-to-date: 20 October 2004
Date Event Description
5 August 2008 Amended Converted to new review format.

HISTORY
Protocol first published: Issue 4, 1999
Review first published: Issue 2, 2003
Date Event Description
21 October 2004 New citation required and conclusions have changed Substantive amendment
CONTRIBUTIONS OF AUTHORS
Conceiving the review: DM, ANA.
Designing the review: KFG, DM, AAC, ANA.
Coordinating the review: KFG.
Data collection for the review
Developing search strategy: AAC.
Undertaking searches: KFG, AAC.
Screening search results: KFG, DM, AAC.
Organising retrieval of papers: KFG, DM, AAC.
Screening retrieved papers against inclusion criteria: KFG, DM, AAC.
Appraising quality of papers: KFG, DM, AAC.
Abstracting data from papers: KFG, DM, AAC.
Writing to authors of papers for additional information: DM, KFG.
Providing additional data about papers: DM, KFG.
Obtaining and screening data on unpublished studies: Not applicable.
Data management for the review: KFG, DM, AAC, PWJ.
Entering data into RevMan: KFG, PWJ.
Analysis of data: KFG, DM, AAC, PWJ
Interpretation of data: KFG, DM, AAC, PWJ.
Providing a methodological perspective: KFG, DM, AAC, ANA.
Providing a clinical perspective: KFG, DM, AAC, PWJ.
Providing a policy perspective: DM.
Providing a consumer perspective: none.
Writing the review: KFG, DM, AAC, PWJ.
Providing general advice on the review: DM , ANA.
Securing funding for the review: DM, ANA, PWJ.
Performing previous work that was the foundation of current study: Not applicable.
DECLARATIONS OF INTEREST
None known
SOURCES OF SUPPORT
Internal sources
• Clinical Trials and Meta-analyses Unit, Federal University of São Paulo, Brazil.
• Surgical Gastroenterology Department, Federal University of São Paulo, Brazil.
• Cochrane Colorectal Cancer Group, Denmark.
External sources
• The Valerie Jefferson Fund, UK.

• SanMed - Materiais Médicos Hospitalares Ltda., Brazil.
NOTES
This review last updated November 2004
INDEX TERMS
Medical Subject Headings (MeSH)
Colorectal Surgery; Digestive System Surgical Procedures [∗ adverse effects]; Fecal Incontinence [etiology; prevention & control];
Preoperative Care [∗ methods]; Randomized Controlled Trials as Topic; Surgical Procedures, Elective [∗ adverse effects]; Surgical Wound
Dehiscence [prevention & control]; Surgical Wound Infection [prevention & control]
MeSH check words
Humans


Mechanical Bowel Prep Elective Colorectal Surgery Cochrane

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Mechanical Bowel Prep Elective Colorectal Surgery Cochrane

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Mechanical bowel preparation for elective colorectal surgery

Guenaga KKFG, Atallah ÁN, Castro AA, Matos D, Wille-Jørgensen P

Mechanical bowel preparation for elective colorectal surgery (Review)

Mechanical bowel preparation for elective colorectal surgery (Review) i

Mechanical bowel preparation for elective colorectal surgery

Data collection and analysis

Mechanical bowel preparation for elective colorectal surgery (Review) 2

Mechanical bowel preparation before colorectal surgery cannot be recommended as routine.

Mechanical bowel preparation for elective colorectal surgery (Review) 4

Mechanical bowel preparation for elective colorectal surgery (Review) 5

Mechanical bowel preparation for elective colorectal surgery (Review) 6

Mechanical bowel preparation for elective colorectal surgery (Review) 7

Mechanical bowel preparation for elective colorectal surgery (Review) 8

Mechanical bowel preparation for elective colorectal surgery (Review) 10

Characteristics of included studies [ordered by study ID]

Methods Randomisation, blinding, follow-up, withdrawal and dropout: no details.

Mechanical bowel preparation for elective colorectal surgery (Review) 11

Methods Randomisation and blinding: no details

Methods Randomisation: no details.

Mechanical bowel preparation for elective colorectal surgery (Review) 12

Methods Randomization: no details.

Methods Randomization: sealed envelopes; consecutive adult patients.

Outcomes Wound infection: A=5; B=3.

Methods Randomisation: patients were allocated by randomised cards.

Interventions Group A - Mechanical bowel preparation (n= 72):

Outcomes Wound infection: A=2; B=0.

Methods Randomisation: Computer generated.

Mechanical bowel preparation for elective colorectal surgery (Review) 17

Study Reason for exclusion

Mechanical bowel preparation for elective colorectal surgery (Review) 18

Comparison 1. Mechanical bowel preparation versus no preparation

Mechanical bowel preparation for elective colorectal surgery (Review) 19

1 Leakage after low anterior resection

Miettinen 2000 3/9 2/14 21.9 % 2.92 [ 0.40, 21.25 ]

Santos 1994 2/21 2/29 20.5 % 1.42 [ 0.18, 11.01 ]

Zmora 2003 3/43 1/40 21.6 % 2.62 [ 0.36, 19.34 ]

Subtotal (95% CI) 112 119 100.0 % 1.45 [ 0.57, 3.67 ]

Miettinen 2000 2/129 1/115 18.1 % 1.75 [ 0.18, 17.02 ]

Santos 1994 5/51 2/48 40.1 % 2.34 [ 0.51, 10.80 ]

Zmora 2003 4/144 3/153 41.8 % 1.42 [ 0.32, 6.37 ]

Subtotal (95% CI) 367 367 100.0 % 1.80 [ 0.68, 4.75 ]

0.01 0.1 1 10 100

Mechanical bowel preparation for elective colorectal surgery (Review) 20

1 Leakage after low anterior resection

Miettinen 2000 3/9 2/14 2.92 [ 0.40, 21.25 ]

Santos 1994 2/21 2/29 1.42 [ 0.18, 11.01 ]

Zmora 2003 3/43 1/40 2.62 [ 0.36, 19.34 ]

Subtotal (95% CI) 112 119 1.45 [ 0.57, 3.67 ]

0.01 0.1 1 10 100

Review: Mechanical bowel preparation for elective colorectal surgery

2 Leakage after colonic surgery

Miettinen 2000 2/129 1/115 1.75 [ 0.18, 17.02 ]

Santos 1994 5/51 2/48 2.34 [ 0.51, 10.80 ]

Zmora 2003 4/144 3/153 1.42 [ 0.32, 6.37 ]

Subtotal (95% CI) 367 367 1.80 [ 0.68, 4.75 ]

0.01 0.1 1 10 100

Mechanical bowel preparation for elective colorectal surgery (Review) 21

Bucher 2003 4/47 1/46 7.0 % 3.43 [ 0.57, 20.59 ]

Burke 1994 3/82 4/87 9.8 % 0.79 [ 0.17, 3.58 ]

Fa-Si-Oen 2003 7/125 6/125 18.0 % 1.18 [ 0.39, 3.58 ]

Fillmann 1995 2/30 1/30 4.2 % 1.99 [ 0.20, 19.94 ]

Miettinen 2000 5/138 3/129 11.3 % 1.56 [ 0.38, 6.36 ]

Santos 1994 7/72 4/77 14.9 % 1.93 [ 0.57, 6.57 ]