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Completed

NCT Number: NCT00288496

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.

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Key information

Conditions

Anastomotic Dehiscence in Colorectal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caroline Contant

Rotterdam, Montessoriweg 1, 3083 AN, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

polyethylene glycol bowel lavage solution

Drug

Primary outcomes

  1. The primary endpoint of the study was anastomotic failure.

Secondary outcomes

  1. Secondary endpoints were septic complications (wound infection, urinary infection, pneumonia, pelvic abscesses), fascia dehiscence and death.

Sponsors and collaborators

Lead sponsor

Ikazia Hospital, Rotterdam

Other

Registry information

Official study title

Mechanical Bowel Preparation for Elective Colorectal Surgery. A Multicenter Randomized Study

Important dates

Study start
1998
Study completion
2004
First posted
Feb 8, 2006
Registry last updated
Feb 8, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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