Elsevier

The Lancet

Volume 370, Issue 9605, 22 December 2007–4 January 2008, Pages 2112-2117
The Lancet

Articles
Mechanical bowel preparation for elective colorectal surgery: a multicentre randomised trial

https://doi.org/10.1016/S0140-6736(07)61905-9Get rights and content

Summary

Background

Mechanical bowel preparation is a common practice before elective colorectal surgery. We aimed to compare the rate of anastomotic leakage after elective colorectal resections and primary anastomoses between patients who did or did not have mechanical bowel preparation.

Methods

We did a multicentre randomised non-inferiority study at 13 hospitals. We randomly assigned 1431 patients who were going to have elective colorectal surgery to either receive mechanical bowel preparation or not. Patients who did not have mechanical bowel preparation had a normal meal on the day before the operation. Those who did were given a fluid diet, and mechanical bowel preparation with either polyethylene glycol or sodium phosphate. The primary endpoint was anastomotic leakage, and the study was designed to test the hypothesis that patients who are given mechanical bowel preparation before colorectal surgery do not have a lower risk of anastomotic leakage than those who are not. The median follow-up was 24 days (IQR 17–34). We analysed patients who were treated as per protocol. This study is registered with ClinicalTrials.gov, number NCT00288496.

Findings

77 patients were excluded: 46 who did not have a bowel resection; 21 because of missing outcome data; and 10 who withdrew, cancelled, or were excluded for other reasons. The rate of anastomotic leakage did not differ between both groups: 32/670 (4·8%) patients who had mechanical bowel preparation and 37/684 (5·4%) in those who did not (difference 0·6%, 95% CI −1·7% to 2·9%, p=0·69). Patients who had mechanical bowel preparation had fewer abscesses after anastomotic leakage than those who did not (2/670 [0·3%] vs 17/684 [2·5%], p=0·001). Other septic complications, fascia dehiscence, and mortality did not differ between groups.

Interpretation

We advise that mechanical bowel preparation before elective colorectal surgery can safely be abandoned.

Introduction

Symptomatic anastomotic leakage is the most important surgical complication after colorectal surgery and can cause morbidity and mortality. Mechanical bowel preparation has been regarded as an efficient strategy to prevent anastomotic leakage and septic complications. Observational data and expert opinions1, 2, 3, 4 have traditionally held that mechanical bowel preparation before colorectal surgery reduces faecal mass and bacterial count in the lumen. However, in the past few decades, the practice has been questioned.5, 6, 7, 8, 9, 10 In two studies, anastomotic leakage was more likely to occur in patients who had received mechanical bowel preparation before surgery.7, 8 However, these trials were underpowered, because of insufficient participants. We aimed to compare the outcome of elective colorectal resections with and without mechanical bowel preparation in terms of anastomotic leakage and other complications.

Section snippets

Study participants

Between April, 1998, and February, 2004, we enrolled patients at 13 participating hospitals (including nine teaching hospitals) in the Netherlands. The main criterion for inclusion was an indication for elective colorectal surgery with primary anastomosis. Patients were excluded if they had an acute laparotomy; had laparoscopic colorectal surgery; had a contraindication for the use of mechanical bowel preparation; had an a priori deviating ileal stoma; or were aged younger than 18 years.

Results

The figure shows the trial profile. Between April, 1998, and February, 2004, we enrolled 1431 patients. 77 patients were excluded from analysis of the primary endpoint: 46 (3·2%) because they did not have a bowel resection; 21 (1·5%) because we did not have outcome data; and 10 (0·7%) because they either withdrew consent, died, had an acute laparotomy, underwent surgery elsewhere, or cancelled their operation. Baseline characteristics are shown in table 1. By chance, more patients who smoked

Discussion

Our study did not show any differences in anastomotic leakage between patients who were given preoperative mechanical bowel preparation before elective colorectal surgery and those who we not. Mortality and length of hospital stay were also similar in the two groups. However, patients who did not have mechanical bowel preparation had a slightly higher rate of intra-abdominal abscesses after anastomotic leakage. We did not regard the very low rate of abscesses to be of major clinical importance;

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