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

Phase 3

• Conditions: Colorectal Cancer; Perioperative/Postoperative Complications

• Registration Number: NCT00070005
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* 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.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2003-10-03
• Study First Submitted QC: 2003-10-06
• Study First Posted: 2003-10-07
• Status Verified: 2007-04
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional outcome as measured by a validated questionnaire

Secondary Outcome Measures

Name	Time	Method
Quality life as measured by a validated questionnaire
Anorectal function as assessed by anorectal manometry and barostat measurements

Trial Locations

Locations (9)

Academisch Medisch Centrum at University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

St. Lucas - Andreas Ziekenhuis; 🇳🇱 Amsterdam, Netherlands

Isala Klinieken - locatie Weezenlanden; 🇳🇱 Zwolle, Netherlands

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital; 🇳🇱 Amsterdam, Netherlands

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Reinier de Graaf Group - Delft; 🇳🇱 Delft, Netherlands

Gelre Ziekenhuizen - Lokatie Lukas; 🇳🇱 Apeldoorn, Netherlands

Albert Schweitzerziekenhuis - Locatie Amstelwijck; 🇳🇱 Dordrecht NM, Netherlands

Isala Klinieken - locatie Sophia; 🇳🇱 Zwolle, Netherlands