Contact information
Type
Scientific
Primary contact
Dr Caroline Contant
ORCID ID
Contact details
Fransiscus Gasthuis
Department of Surgery
Kleiweg 500
Rotterdam
3045 PM
Netherlands
vbrusselcontant@cs.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00288496
Protocol/serial number
NTR575
Study information
Scientific title
Acronym
POCON trial
Study hypothesis
Mechanical bowel preparation (MBP) is common practice in elective colorectal surgery. In recent literature the value of MBP is a subject of discussion. This non-inferiority, randomised study evaluates the value of MBP before colorectal surgery.
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Elective colorectal resections
Intervention
Patients were randomised before elective colorectal surgery to receive mechanical bowel preparation, consisted of 2-4 l of polyethylene glycol bowel lavage solution in combination with a fluid 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.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Anastomotic failure, based on clinical suspicion (prolonged fever, abdominal pain, local or generalised peritonitis, leucocytosis) resulting in contrast radiography (X-ray or computed tomography [CT] scan) or laparotomy to confirm the diagnosis. No effort was made to screen for asymptomatic leakage.
Secondary outcome measures
1. Septic complications (wound infection, urinary tract infection, pneumonia, pelvic abscesses)
2. Fascia dehiscence
3. Death.
Overall trial start date
15/04/1998
Overall trial end date
19/02/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Elective colorectal resections with primary anastomosis
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
1433
Participant exclusion criteria
1. Acute laparotomy
2. Laparoscopic colorectal surgery
3. Contraindications for the use of mechanical bowel preparation
4. A priori deviating (ileo) stoma
5. Age less than 18 years old
Recruitment start date
15/04/1998
Recruitment end date
19/02/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
Fransiscus Gasthuis
Rotterdam
3045 PM
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Ikazia Hospital (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/18156032
Publication citations
-
Results
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, 2007, 370, 9605, 2112-2117, doi: 10.1016/S0140-6736(07)61905-9.