|- candidate number||1967|
|- NTR Number||NTR575|
|- Date ISRCTN created||14-feb-2006|
|- date ISRCTN requested||13-feb-2006|
|- Date Registered NTR||6-feb-2006|
|- Secondary IDs||N/A |
|- Public Title||Mechanical bowel preparation for elective colorectal surgery.|
|- Scientific Title||Mechanical bowel preparation for elective colorectal surgery. Outcome of a multicenter randomized study.|
|- ACRONYM||POCON trial|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Elective colorectal resections|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-apr-1998|
|- planned closingdate||19-feb-2004|
|- Target number of participants||1433|
|- Interventions||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.|
|- 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.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Caroline Contant|
|- CONTACT for SCIENTIFIC QUERIES|| Caroline Contant|
|- Sponsor/Initiator ||Ikazia Hospital|
(Source(s) of Monetary or Material Support)
|- Publications||Lancet. 2007 Dec 22;370(9605):2112-7
POCON: Preoperatieve Colonvoorbereiding Onzin of Niet? Chirurgendagen, Nederlandse Vereniging voor Heelkunde, mei 2005.
Mechanical bowel preparation.
Colorectaal themajaar 2005, closing congress, Nederlandse Vereniging voor Gastrointestinale chirurgie, Noordwijk, november 2005
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||6-feb-2006 - 12-jun-2008|