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ISRCTN
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ISRCTN78983587
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ClinicalTrials.gov identifier
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Public title
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Colon J-Pouch (CJP) versus transverse coloplasty pouch (TCP) after low anterior resection in rectal cancer: a randomised controlled trial
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Scientific title
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Acronym
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POUCH - Trial
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Serial number at source
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KSC 01/2002
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Rectal cancer
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/06/2002
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Anticipated end date
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30/06/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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130
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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University of Heidelberg Medical School (Germany)
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Trial website
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Publications
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Results:
1. Functional results: http://www.ncbi.nlm.nih.gov/pubmed/15865035
2. Early results: http://www.ncbi.nlm.nih.gov/pubmed/18720469
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Contact name
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Prof
Markus W
Büchler
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Address
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Im Neuenheimer Feld 110
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City/town
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Heidelberg
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Zip/Postcode
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69120
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Country
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Germany
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Tel
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+49 6221 56 6200
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Fax
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+49 6221 56 6988
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Email
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markus.buechler@med.uni-heidelberg.de
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Sponsor
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University of Heidelberg Medical School (Germany)
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Address
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Im Neuenheimer Feld 110
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City/town
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Heidelberg
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Zip/Postcode
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69120
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Country
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Germany
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Tel
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+49 6221 56 6200
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Fax
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+49 6221 56 6988
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Email
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markus.buechler@med.uni-heidelberg.de
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Date applied
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08/12/2004
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Last edited
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15/09/2008
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Date ISRCTN assigned
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24/01/2005
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