Trial Information

Colonic J-Pouch Reconstruction Versus Straight Colorectal Anastomosis After Low Anterior Resection for Rectal Cancer: Impact on Anastomotic Leak, Bowel Function and Quality of Life

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.