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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN78983587 |
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Date of registration:
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24/01/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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Date of first enrolment:
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01/06/2002 |
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Target sample size:
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130 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN78983587 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Markus W
Büchler |
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Address:
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Im Neuenheimer Feld 110
69120
Heidelberg
Germany |
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Telephone:
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+49 6221 56 6200 |
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Email:
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markus.buechler@med.uni-heidelberg.de |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Rectal cancer
Cancer
Rectal cancer
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Intervention(s)
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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(s)
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Not provided at time of registration
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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KSC 01/2002
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Source(s) of Monetary Support
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University of Heidelberg Medical School (Germany)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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