Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: 5 cm colon-J-pouch; Procedure: side-to-end anastomosis; Procedure: straight coloanal anastomosis

• Registration Number: NCT00238381
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-13
• Primary Completion: 2014-05
• Study Completion: 2016-08
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II	5 cm colon-J-pouch	Patients undergo TME and colon-J-pouch anastomosis rectal reconstruction.
Arm I	side-to-end anastomosis	Patients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction.
Arm III	straight coloanal anastomosis	Patients undergo straight coloanal anastomosis with/without temporary protective ileostomy

Primary Outcome Measures

Name	Time	Method
Composite evacuation score after total mesorectal excision	12 months after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (18)

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland

Kreiskrankenhaus Lörrach; 🇩🇪 Lörrach, Germany

Inselspital Bern; 🇨🇭 Bern, Switzerland

Hopital de La Chaux-de-Fonds; 🇨🇭 La Chaux-de-Fonds, Switzerland

Hopitaux Universitaires de Geneve; 🇨🇭 Geneva, Switzerland

Kantonsspital Bruderholz; 🇨🇭 Bruderholz, Switzerland

Ospedale Beata Vergine; 🇨🇭 Mendrisio, Switzerland

Zuger Kantonsspital AG; 🇨🇭 Baar, Switzerland

Bezirksspital Dornach; 🇨🇭 Dornach, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland

Klinik Hirslanden; 🇨🇭 Zurich, Switzerland

Universitaetsspital-Basel; 🇨🇭 Basel, Switzerland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Kantonsspital Luzern; 🇨🇭 Luzerne, Switzerland

UniversitaetsSpital Zuerich; 🇨🇭 Zurich, Switzerland

Kantonsspital Olten; 🇨🇭 Olten, Switzerland

GZO Spital Wetzikon; 🇨🇭 Wetzikon, Switzerland

City Hospital Triemli; 🇨🇭 Zurich, Switzerland