Mechanical Bowel Preparation for Elective Colorectal Surgery

Anastomotic Dehiscence in Colorectal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288496
• Other study ID #: POCON trial
• Status: Completed
• Phase: N/A
• First received: February 7, 2006
• Last updated: February 7, 2006
• Start date: April 1998
• Est. completion date: February 2004

Study information

• Verified date: April 2000
• Source: Ikazia Hospital, Rotterdam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anastomotic Dehiscence in Colorectal Surgery

Intervention

Drug:
• polyethylene glycol bowel lavage solution

Locations

Country	Name	City	State
Netherlands	Caroline Contant	Rotterdam	Montessoriweg 1

Sponsors (1)

Lead Sponsor	Collaborator
Ikazia Hospital, Rotterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of the study was anastomotic failure.
Secondary	Secondary endpoints were septic complications (wound infection, urinary infection, pneumonia, pelvic abscesses), fascia dehiscence and death.