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J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00070005
Recruitment Status : Unknown
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : October 7, 2003
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: A coloanal anastomosis may be effective in restoring bowel function after radiation therapy and surgery to remove the rectum. It is not yet known whether a J-pouch coloanal anastomosis is more effective than a side-to-end coloanal anastomosis in restoring bowel function in patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.

PURPOSE: This randomized phase III trial is studying how well J-pouch coloanal anastomosis works compared to side-to-end coloanal anastomosis in treating patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Perioperative/Postoperative Complications Procedure: conventional surgery Procedure: management of therapy complications Phase 3

Detailed Description:



  • Compare functional outcome in patients with mid- or distal rectal adenocarcinoma when treated with J-pouch coloanal anastomosis vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision.


  • Compare the quality of life of patients treated with these procedures.
  • Compare anorectal function in patients treated with these procedures.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and gender. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo total mesorectal excision followed by a J-pouch coloanal anastomosis.
  • Arm II: Patients undergo total mesorectal excision followed by a side-to-end coloanal anastomosis.

In both arms, patients receive a temporary ileostomy. The ileostomy is closed after 1 week provided recovery is uneventful and no radiological signs of anastomotic leakage are detected. If early closure is not possible, the ileostomy is closed after 6-8 weeks.

Functional outcome, quality of life, and anorectal function are assessed before surgery and at 4 and 12 months after surgery.

PROJECTED ACCRUAL: A minimum of 100 patients (50 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: A Phase III Randomised Study Of J-Pouch Coloanal Anastomosis Versus Side-To-End Coloanal Anastomosis After Preoperative Radiotherapy And Total Mesorectal Excision In Patients With Mid And Distal Rectal Cancer
Study Start Date : June 2002

Primary Outcome Measures :
  1. Functional outcome as measured by a validated questionnaire

Secondary Outcome Measures :
  1. Quality life as measured by a validated questionnaire
  2. Anorectal function as assessed by anorectal manometry and barostat measurements

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the rectum

    • T2 or T3 disease
  • Disease located in the mid- or distal rectum
  • No evidence of metastatic disease
  • No preexisting grade III or IV incontinence
  • Completed preoperative radiotherapy (5 x 5 Gy) before study entry



  • Over 18

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Working knowledge of the Dutch language


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • No prior radiotherapy to the pelvis


  • No prior colon resection
  • No prior anorectal surgery
  • No concurrent abdominoperineal resection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00070005

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Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
St. Lucas - Andreas Ziekenhuis
Amsterdam, Netherlands, 1091 AE
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Gelre Ziekenhuizen - Lokatie Lukas
Apeldoorn, Netherlands, 7300 DS
Reinier de Graaf Group - Delft
Delft, Netherlands, 2625 AD
Albert Schweitzerziekenhuis - Locatie Amstelwijck
Dordrecht NM, Netherlands, NL-3317
Isala Klinieken - locatie Sophia
Zwolle, Netherlands, 8000 GK
Isala Klinieken - locatie Weezenlanden
Zwolle, Netherlands, 8000 GK
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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Study Chair: Roel Bakx, MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Layout table for additonal information Identifier: NCT00070005    
Other Study ID Numbers: CKTO-2002-02-POCASTER
CDR0000328269 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: October 7, 2003    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: April 2007
Keywords provided by National Cancer Institute (NCI):
perioperative/postoperative complications
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
adenocarcinoma of the rectum
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes