Mechanical bowel preparation for elective colorectal surgery
| ISRCTN | ISRCTN85321563 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85321563 |
| ClinicalTrials.gov (NCT) | NCT00288496 |
| Protocol serial number | NTR575 |
| Sponsor | Ikazia Hospital (Netherlands) |
| Funder | Ikazia Hospital (Netherlands) |
- 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
Scientific
Fransiscus Gasthuis
Department of Surgery
Kleiweg 500
Rotterdam
3045 PM
Netherlands
| vbrusselcontant@cs.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | POCON trial |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Septic complications (wound infection, urinary tract infection, pneumonia, pelvic abscesses) |
| Completion date | 19/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 1433 |
| Key inclusion criteria | Elective colorectal resections with primary anastomosis |
| Key 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 |
| Date of first enrolment | 15/04/1998 |
| Date of final enrolment | 19/02/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Fransiscus Gasthuis
Rotterdam
3045 PM
Netherlands
3045 PM
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
