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

May 14, 2019 updated by: Swiss Group for Clinical Cancer Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

336

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Lörrach, Germany, 79539
        • Kreiskrankenhaus Lörrach
  • Switzerland
      • Aarau, Switzerland, CH-5001
        • Kantonsspital Aarau
      • Baar, Switzerland, 6340
        • Zuger Kantonsspital AG
      • Basel, Switzerland, CH-4031
        • Universitaetsspital-Basel
      • Bern, Switzerland, CH-3010
        • Inselspital Bern
      • Bruderholz, Switzerland, CH-4101
        • Kantonsspital Bruderholz
      • Dornach, Switzerland, CH-4143
        • Bezirksspital Dornach
      • Geneva, Switzerland, CH-1226
        • Hôpitaux Universitaires de Genève
      • La Chaux-de-Fonds, Switzerland, CH 2300
        • Hopital de La Chaux-de-Fonds
      • Lausanne, Switzerland, CH-1011
        • Centre hospitalier universitaire vaudois
      • Luzerne, Switzerland, CH-6000
        • Kantonsspital Luzern
      • Mendrisio, Switzerland, CH-6850
        • Ospedale Beata Vergine
      • Olten, Switzerland, CH-4600
        • Kantonsspital Olten
      • Wetzikon, Switzerland, 8620
        • GZO Spital Wetzikon
      • Winterthur, Switzerland, CH-8400
        • Kantonsspital Winterthur
      • Zurich, Switzerland, CH-8063
        • City Hospital Triemli
      • Zurich, Switzerland, CH-8091
        • Universitaetsspital Zuerich
      • Zurich, Switzerland, CH-8032
        • Klinik Hirslanden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite evacuation score after total mesorectal excision
Time Frame: 12 months after surgery
12 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Group for Clinical Cancer Research

Investigators

  • Study Chair: Christian T. Hamel, MD, Kantonsspital - Abteilung Onkologie
  • Study Chair: Walter R. Marti, Prof., Kantonsspital Aarau
  • Study Chair: Markus Zuber, MD, Kantonsspital Olten

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (Estimate)

October 13, 2005

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAKK 40/04
  • EU-20528

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe