Sponsor study identifier
interventional
1,400
1 country
1
Study Start
April 1998
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
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April 1998
Date type not reportedThis date has not been verified as actual or estimated.
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
February 7, 2006
Actual (reported)February 8, 2006
Actual (reported)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.
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Caroline Contant
Rotterdam, Montessoriweg 1, 3083 AN, Netherlands
Contant CM, Hop WC, van't Sant HP, Oostvogel HJ, Smeets HJ, Stassen LP, Neijenhuis PA, Idenburg FJ, Dijkhuis CM, Heres P, van Tets WF, Gerritsen JJ, Weidema WF. Mechanical bowel preparation for elective colorectal surgery: a multicentre randomised trial. Lancet. 2007 Dec 22;370(9605):2112-7. doi: 10.1016/S0140-6736(07)61905-9.
Caroline ME Contant, PhD
Ikazia Hospital
First Submitted
February 7, 2006
First Posted
February 8, 2006
Study Start
April 1998
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
February 8, 2006
Record last verified: 2000-04
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Source: ClinicalTrials.gov.
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