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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase: Unknown; Phase 3

Conditions: Perioperative/Postoperative Complications; Colorectal Cancer

Treatments: Procedure: conventional surgery; Procedure: management of therapy complications

Study type: Interventional

Funder types: Other

Identifiers

NCT00070005

CDR0000328269 (Registry Identifier)

EU-20247

CKTO-2002-02-POCASTER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Working knowledge of the Dutch language

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• No prior radiotherapy to the pelvis

Surgery

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