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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Perioperative/Postoperative Complications

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Functional outcome as measured by a validated questionnaire

Principal Investigator

Roel Bakx, MD

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CDR0000328269

NCT ID:

NCT00070005

Start Date:

June 2002

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Perioperative/Postoperative Complications
  • perioperative/postoperative complications
  • stage I rectal cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • adenocarcinoma of the rectum
  • Adenocarcinoma
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Postoperative Complications

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