Mechanical bowel preparation for elective colorectal surgery

ISRCTN ISRCTN85321563
DOI https://doi.org/10.1186/ISRCTN85321563
ClinicalTrials.gov number NCT00288496
Secondary identifying numbers NTR575
Submission date
14/02/2006
Registration date
14/02/2006
Last edited
26/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Caroline Contant
Scientific

Fransiscus Gasthuis
Department of Surgery
Kleiweg 500
Rotterdam
3045 PM
Netherlands

Email vbrusselcontant@cs.com

Study information

Study designMulticentre randomised controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymPOCON trial
Study objectivesMechanical 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(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedElective colorectal resections
InterventionPatients 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 typeProcedure/Surgery
Primary outcome measureAnastomotic 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 measures1. Septic complications (wound infection, urinary tract infection, pneumonia, pelvic abscesses)
2. Fascia dehiscence
3. Death.
Overall study start date15/04/1998
Completion date19/02/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants1433
Key inclusion criteriaElective colorectal resections with primary anastomosis
Key exclusion criteria1. 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
Date of first enrolment15/04/1998
Date of final enrolment19/02/2004

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Fransiscus Gasthuis
Rotterdam
3045 PM
Netherlands

Sponsor information

Ikazia Hospital (Netherlands)
Hospital/treatment centre

Montessoriweg 1
Rotterdam
3083 AN
Netherlands

ROR logo "ROR" https://ror.org/01abkkw91

Funders

Funder type

Hospital/treatment centre

Ikazia Hospital (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 22/12/2007 Yes No