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Mechanical Bowel Preparation for Elective Colorectal Surgery

This study has been completed.
Sponsor:
Information provided by:
Ikazia Hospital, Rotterdam
ClinicalTrials.gov Identifier:
NCT00288496
First received: February 7, 2006
Last updated: NA
Last verified: April 2000
History: No changes posted
  Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288496

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

No publications provided by Ikazia Hospital, Rotterdam

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00288496     History of Changes
Other Study ID Numbers: POCON trial
Study First Received: February 7, 2006
Last Updated: February 7, 2006
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Ikazia Hospital, Rotterdam:
mechanical bowel preparation, colorectal surgery, anastomotic dehiscence

ClinicalTrials.gov processed this record on May 19, 2013