Mechanical Bowel Preparation for Elective Colorectal Surgery
Mechanical bowel preparation (MBP) is common practice in elective colorectal surgery. In recent literature the value of MBP is subject of discussion. We conducted a multicenter, randomized study with the goal of comparing outcome of elective colorectal resections and primary anastomoses with and without mechanical bowel preparation in terms of anastomotic leakage and other septic complications.
Within the setting of a multicenter randomized trial,1433 patients were randomized before elective colorectal surgery to receive either MBP or to have no MBP but a normal meal on the day before operation. The primary endpoint was anastomotic leakage. Secondary endpoints were septic complications (wound infection, urinary infection, pneumonia, pelvic abscesses), fascia dehiscence and death.
The incidence of anastomotic leakage was similar in both groups: 5.1% in patients without MBP versus 4.9% in patients with MBP (p=0.93; 95% confidence interval for the difference (no MBP minus MBP) ranges from –2.3% tot +2.7%). There were no significant differences in other septic complications, fascia dehiscence, or mortality. Fecal contamination, number of days until resumption of a normal diet, and duration of hospital stay were similar in both groups.
This study shows that elective colorectal surgery can be safely done without MBP. Therefore, MBP should be abandoned in elective colorectal surgery.
Anastomotic Dehiscence in Colorectal Surgery
Drug: polyethylene glycol bowel lavage solution
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Mechanical Bowel Preparation for Elective Colorectal Surgery. A Multicenter Randomized Study|
- The primary endpoint of the study was anastomotic failure.
- Secondary endpoints were septic complications (wound infection, urinary infection, pneumonia, pelvic abscesses), fascia dehiscence and death.
|Study Start Date:||April 1998|
|Estimated Study Completion Date:||February 2004|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288496
|Rotterdam, Montessoriweg 1, Netherlands, 3083 AN|
|Principal Investigator:||Caroline ME Contant, PhD||Ikazia Hospital|