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Mechanical Bowel Preparation for Elective Colorectal Surgery

This study has been completed.
Information provided by:
Ikazia Hospital, Rotterdam Identifier:
First received: February 7, 2006
Last updated: NA
Last verified: April 2000
History: No changes posted

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 Intervention
Anastomotic Dehiscence in Colorectal Surgery
Drug: polyethylene glycol bowel lavage solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mechanical Bowel Preparation for Elective Colorectal Surgery. A Multicenter Randomized Study

Further study details as provided by Ikazia Hospital, Rotterdam:

Primary Outcome Measures:
  • The primary endpoint of the study was anastomotic failure.

Secondary Outcome Measures:
  • Secondary endpoints were septic complications (wound infection, urinary infection, pneumonia, pelvic abscesses), fascia dehiscence and death.

Estimated Enrollment: 1400
Study Start Date: April 1998
Estimated Study Completion Date: February 2004

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

The main inclusion criterion was elective colorectal surgery with primary anastomosis

Exclusion Criteria:

Exclusion criteria were an acute laparotomy, laparoscopic colorectal surgery, contraindications for the use of mechanical bowel preparation, an a priori deviating (ileo) stoma, and age less than 18 years old.

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Please refer to this study by its identifier: NCT00288496

Caroline Contant
Rotterdam, Montessoriweg 1, Netherlands, 3083 AN
Sponsors and Collaborators
Ikazia Hospital, Rotterdam
Principal Investigator: Caroline ME Contant, PhD Ikazia Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00288496     History of Changes
Other Study ID Numbers: POCON trial
Study First Received: February 7, 2006
Last Updated: February 7, 2006

Keywords provided by Ikazia Hospital, Rotterdam:
mechanical bowel preparation, colorectal surgery, anastomotic dehiscence processed this record on May 25, 2017