J-Pouch Colorectal Anastomosis or Straight Colorectal Anastomosis in Treating Patients With Rectal Cancer Who Have Undergone Surgery to Remove the Tumor

University of Padua

Status: Unknown

Conditions: Perioperative/Postoperative Complications; Gastrointestinal Complications; Colorectal Cancer

Treatments: Procedure: quality-of-life assessment; Procedure: gastrointestinal complications management/prevention; Procedure: therapeutic conventional surgery; Other: intraoperative complication management/prevention; Procedure: assessment of therapy complications

Study type: Interventional

Funder types: Other

Identifiers

NCT01110798

EU-21032

USP-1935P

CDR0000671070

Details and patient eligibility

About

RATIONALE: It is not yet known whether a J-pouch colorectal anastomosis is more effective than a straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.

PURPOSE: This randomized clinical trial is studying J-pouch colorectal anastomosis to see how well it works compared with straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.

Full description

OBJECTIVES:

Primary

• To assess whether the incidence of major anastomotic leak after low anterior resection, in patients with rectal cancer, is reduced by using the J-pouch reconstruction vs straight colorectal anastomosis.

Secondary

• To compare the global anastomotic leak (major and minor) rate, the incidence of other complications in addition to anastomotic leak, and the functional outcome and the quality of life in these patients.
• To describe, in the J-pouch reconstruction group, the feasibility of the colonic J-pouch.

OUTLINE: Ths is a multicenter study. Patients are stratified according to clinical center, gender (male vs female), and neoadjuvant treatment types. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo a total mesorectal excision with a low anterior rectal resection followed by a mechanical straight stapled colorectal anastomosis.
• Arm II: Patients undergo a total mesorectal excision with a low anterior rectal resection followed by a mechanical J-pouch stapled anastomosis reconstruction.

Quality of life is assessed periodically using EORTC Quality of Life Questionnaires (EORTC QLQ-C30 and -CR38), and the MSKCC Bowel Function Questionnaire.

After completion of study treatment, patients are followed at 1, 6, 12, and 24 months.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed rectal adenocarcinoma meeting the following criteria:

  • Mid and/or low rectal cancer
  • Tumor site ≤ 11 cm from anal verge
  • Must have a temporary stoma (ileostomy or colostomy)

• Must be scheduled for a total mesorectal excision with a low anterior rectal resection and mechanic colorectal anastomosis that is potentially curative or with a microscopic residual resection (R0-R1)

• No locally recurrent disease

• No distant metastasis

PATIENT CHARACTERISTICS:

• Must be able to understand the study

PRIOR CONCURRENT THERAPY:

• No prior handsewn coloanal anastomosis
• No prior colonic resection
• No prior surgery for local recurrence