Colon J-Pouch (CJP) versus transverse coloplasty pouch (TCP) after low anterior resection in rectal cancer: a randomised controlled trial
ISRCTN | ISRCTN78983587 |
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DOI | https://doi.org/10.1186/ISRCTN78983587 |
Secondary identifying numbers | KSC 01/2002 |
- Submission date
- 08/12/2004
- Registration date
- 24/01/2005
- Last edited
- 15/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Markus W Büchler
Scientific
Scientific
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
Phone | +49 6221 56 6200 |
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markus.buechler@med.uni-heidelberg.de |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | POUCH - Trial |
Study objectives | 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 |
Health condition(s) or problem(s) studied | 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 |
Completion date | 30/06/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 130 |
Key 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. |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/06/2002 |
Date of final enrolment | 30/06/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
69120
Germany
Sponsor information
University of Heidelberg Medical School (Germany)
University/education
University/education
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
Phone | +49 6221 56 6200 |
---|---|
markus.buechler@med.uni-heidelberg.de | |
https://ror.org/038t36y30 |
Funders
Funder type
University/education
University of Heidelberg Medical School (Germany)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
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 |