Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments 5 cm colon-j-pouch, side-to-end anastomosis, straight coloanal anastomosis
Phase phase 3
Sponsor Swiss Group for Clinical Cancer Research
Start date July 2005
End date May 2014
Trial size 336 participants
Trial identifier NCT00238381, EU-20528, SAKK 40/04

Summary

RATIONALE: Rectal reconstruction after surgery to treat rectal cancer may help patients keep some of their bowel function. It is not yet known which method of rectal reconstruction is most effective after surgery.

PURPOSE: This randomized phase III trial is studying three different methods of rectal reconstruction to compare how well they work in treating patients who are undergoing surgery for rectal cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Patients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction.
side-to-end anastomosis
side-to-end anastomosis with/without temporary protective ileostomy
(Other)
Patients undergo TME and colon-J-pouch anastomosis rectal reconstruction.
5 cm colon-j-pouch
5 cm colon-J-pouch with/without temporary protective ileostomy
(Other)
Patients undergo straight coloanal anastomosis with/without temporary protective ileostomy
straight coloanal anastomosis
straight coloanal anastomosis with/without temporary protective ileostomy

Primary Outcomes

Measure
Composite evacuation score after total mesorectal excision
time frame: 12 months after surgery

Secondary Outcomes

Measure
Composite evacuation score at 6, 18, and 24 months after total mesorectal excision
time frame: 6, 18 and 24 months after surgery
Composite incontinence score after total mesorectal excision
time frame: 6, 12, 18 and 24 months
Quality of life after total mesorectal excision
time frame: 6, 12m 18 and 24 months
Overall survival
time frame: 2 years follow-up
Morbidity
time frame: 2 years follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

- Histologically proven rectal adenocarcinoma or rectal adenoma with/without neoadjuvant radiochemotherapy - Total mesorectal excision needed - Age ≥ 18 years - Clinically normal function of the sphincter muscles (no history of frequent fecal incontinence for liquid or solid stools) - Any T, any N, any M or adenoma - An R0-resection is expected (liver metastases planned to be simultaneously - Written informed consent, signed and dated by the patient and the investigator - Completed baseline quality of life questionnaire Exclusion criteria: - Rectal tumor other than adenocarcinoma or adenoma - Previous rectal cancer surgery, other than local excision within the last 2 months - Histologically proven chronic inflammatory bowel disease - Contraindications to any of the 3 surgical techniques - BMI > 35 - Patients with psychiatric, addictive or any disorder that would prohibit the understanding and giving of informed consent, completing the QL questionnaires and/or following the structured interview - Inability to read and understand any of the languages available on the QL questionnaires,and spoken during the interview (German, French, Italian)

Additional Information

Official title Clinical Function After Total Mesorectal Excision and Rectal Replacement. A Prospective Randomized Trial Comparing Side-to-End Anastomosis, Colon-J-Pouch and Straight Coloanal Anastomosis
Description This is a randomized, multicenter study. Patients are stratified according to participating center, gender, distance of the distal tumor margin from the dentate line (> 5 cm vs ≤ 5 cm), age (< 70 vs ≥ 70), neoadjuvant chemoradiotherapy (yes vs no), and distant metastasis (M0 vs M1). Patients are randomized to 1 of 3 treatment arms.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Swiss Group for Clinical Cancer Research.