No registrations found.
ID
Source
Brief title
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study was anastomotic failure, which was based on clinical suspicion (prolonged fever, abdominal pain, local or generalized peritonitis, leucocytosis) resulting in contrast radiography (X-ray or CT-scan) or laparotomy to confirm the diagnosis. No effort was made to screen for asymptomatic leakage.
Secondary outcome
Secondary endpoints were septic complications (wound infection, urinary tract infection, pneumonia, pelvic abscesses), fascia dehiscence and death.
Background 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.
Study objective
Mechanical bowel preparation (MBP) is common practice in elective colorectal surgery. In recent literature the value of MBP is subject of discussion. This non-inferiority, randomized study evaluates the value of MBP before colorectal surgery.
Study design
N/A
Intervention
Patients were randomized before elective colorectal surgery to receive mechanical bowel preparation, consisted of 2-4 liters of polyethylene glycol bowel lavage solution in combination with a fliud diet in one study arm. The other study arm received no mechanical bowel preparation and was allowed to have a normal meal on the day before operation.
Kleiweg 500
Caroline Contant
Kleiweg 500
Rotterdam 3045 PM
The Netherlands
vbrusselcontant@cs.com
Kleiweg 500
Caroline Contant
Kleiweg 500
Rotterdam 3045 PM
The Netherlands
vbrusselcontant@cs.com
Inclusion criteria
Elective colorectal resections with primary anastomosis.
Exclusion criteria
1. Acute laparotomy;
2. laparoscopic colorectal surgery;
3. contraindications for the use of mechanical bowel preparation;
4. an a priori deviating (ileo) stoma;
5. age less than 18 years old.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL531 |
| NTR-old | NTR575 |
| Other | : N/A |
| ISRCTN | ISRCTN85321563 |
Summary results
<br><br>
oral presentation
POCON: Preoperatieve Colonvoorbereiding Onzin of Niet? Chirurgendagen, Nederlandse Vereniging voor Heelkunde, mei 2005.<br>
<br><br>
Mechanical bowel preparation.
Colorectaal themajaar 2005, closing congress, Nederlandse Vereniging voor Gastrointestinale chirurgie, Noordwijk, november 2005