Condition category
Cancer
Date applied
08/12/2004
Date assigned
24/01/2005
Last edited
15/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2002

Overall trial end date

30/06/2005

Reason abandoned

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

Patient

Age group

Not Specified

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results:
1. Functional results: http://www.ncbi.nlm.nih.gov/pubmed/15865035
2. Early results: http://www.ncbi.nlm.nih.gov/pubmed/18720469

Publication citations

  1. Functional results

    Ulrich A, Z'graggen K, Weitz J, Büchler MW, Functional results of the colon J-pouch versus transverse coloplasty pouch in Heidelberg., Recent Results Cancer Res., 2005, 165, 205-211.

  2. Early results

    Ulrich AB, Seiler CM, Z'graggen K, Löffler T, Weitz J, Büchler MW, Early results from a randomized clinical trial of colon J pouch versus transverse coloplasty pouch after low anterior resection for rectal cancer., Br J Surg, 2008, 95, 10, 1257-1263, doi: 10.1002/bjs.6301.

Additional files

Editorial Notes