Anastomotic Dehiscence in Colorectal Surgery Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment