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

February 7, 2006
February 7, 2006
April 1998
Not Provided
The primary endpoint of the study was anastomotic failure.
Same as current
No Changes Posted
Secondary endpoints were septic complications (wound infection, urinary infection, pneumonia, pelvic abscesses), fascia dehiscence and death.
Same as current
Not Provided
Not Provided
 
Mechanical Bowel Preparation for Elective Colorectal Surgery
Mechanical Bowel Preparation for Elective Colorectal Surgery. A Multicenter Randomized Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anastomotic Dehiscence in Colorectal Surgery
Drug: polyethylene glycol bowel lavage solution
Not Provided
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. 2008 Dec 22;370(9605):2112-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1400
February 2004
Not Provided

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00288496
POCON trial
Not Provided
Not Provided
Ikazia Hospital, Rotterdam
Not Provided
Principal Investigator: Caroline ME Contant, PhD Ikazia Hospital
Ikazia Hospital, Rotterdam
April 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP