Colon J-Pouch (CJP) versus transverse coloplasty pouch (TCP) after low anterior resection in rectal cancer: a randomised controlled trial

ISRCTN ISRCTN78983587
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

Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Phone +49 6221 56 6200
Email markus.buechler@med.uni-heidelberg.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymPOUCH - Trial
Study objectivesThe 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) studiedRectal cancer
InterventionPatients 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/06/2002
Completion date30/06/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants130
Key inclusion criteriaFor 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 criteriaNot provided at time of registration
Date of first enrolment01/06/2002
Date of final enrolment30/06/2005

Locations

Countries of recruitment

  • Germany

Study participating centre

Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Sponsor information

University of Heidelberg Medical School (Germany)
University/education

Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Phone +49 6221 56 6200
Email markus.buechler@med.uni-heidelberg.de
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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