Contact information
Type
Scientific
Contact name
Prof Markus W Büchler
ORCID ID
Contact details
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 6221 56 6200
markus.buechler@med.uni-heidelberg.de
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
KSC 01/2002
Study information
Scientific title
Acronym
POUCH - Trial
Study hypothesis
The straight colo-anal anastomosis after LAR/TME is often associated with poor functional results in the first two years. With the Colon J-Pouch (CJP) better early post-operative results could be achieved, however, late evacuation problems occurred. Therefore, the transverse coloplasty pouch (TCP) was developed, which showed good functional results in the early and late post-operative period in phase I/II trials. The purpose of this trial is to compare the CJP with the TCP in terms of surgically related mortality and morbidity as well as functional outcome.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Rectal cancer
Intervention
Patients with rectal cancer of the lower two thirds, eligible for low anterior resection (LAR) with total mesorectal excision (TME).
Patients will be randomized intraoperatively to either the Colon J-Pouch or Transverse Coloplasty group if they are eligible for both. Postoperative follow-up will assess the safety of TCP and CJP after LAR/TME, including postoperative mortality, morbidity and functional results. Functional outcome will be monitored for 24 months. Each participant has to answer questionnaires about their neorectal function after certain time periods.
Intervention type
Other
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/06/2002
Overall study end date
30/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
For inclusion in this trial, patients have to be eligible for low anterior resection with TME due to a tumour of the lower rectum (potential R0 resection). Presumed preservation and a normal function of the rectal sphincter with faecal continence pre-operatively are mandatory.
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
130
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2002
Recruitment end date
30/06/2005
Locations
Countries of recruitment
Germany
Study participating centre
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
Sponsor information
Organisation
University of Heidelberg Medical School (Germany)
Sponsor details
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 6221 56 6200
markus.buechler@med.uni-heidelberg.de
Sponsor type
University/education
Website
ROR
Funders
Funder type
University/education
Funder name
University of Heidelberg Medical School (Germany)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Functional results: | 01/08/2005 | Yes | No | |
| Results article | Early results: | 01/10/2008 | Yes | No |