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A journal about importance of bowel preparation in preparation for colorectal surgery
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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
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-
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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)
4. There is insufficient evidence to support or refute the
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)
6. There is insufficient evidence to support or refute the
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
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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
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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
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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
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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
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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
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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-
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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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