Condition category
Surgery
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
26/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Ikazia Hospital (Netherlands)

Sponsor details

Montessoriweg 1
Rotterdam
3083 AN
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes