Mechanical Bowel Preparation for Elective Colorectal Surgery
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|ClinicalTrials.gov Identifier: NCT00288496|
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : February 8, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Anastomotic Dehiscence in Colorectal Surgery||Drug: polyethylene glycol bowel lavage solution||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mechanical Bowel Preparation for Elective Colorectal Surgery. A Multicenter Randomized Study|
|Study Start Date :||April 1998|
|Study Completion Date :||February 2004|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288496
|Rotterdam, Montessoriweg 1, Netherlands, 3083 AN|
|Principal Investigator:||Caroline ME Contant, PhD||Ikazia Hospital|