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

This study is currently recruiting participants.
Verified December 2013 by Swiss Group for Clinical Cancer Research
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00238381
First received: October 12, 2005
Last updated: December 8, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Procedure: 5 cm colon-J-pouch
Procedure: side-to-end anastomosis
Procedure: straight coloanal anastomosis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Composite evacuation score after total mesorectal excision [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite evacuation score at 6, 18, and 24 months after total mesorectal excision [ Time Frame: 6, 18 and 24 months after surgery ] [ Designated as safety issue: No ]
  • Composite incontinence score after total mesorectal excision [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Quality of life after total mesorectal excision [ Time Frame: 6, 12m 18 and 24 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years follow-up ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: 2 years follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 336
Study Start Date: July 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Arm III
Patients undergo straight coloanal anastomosis with/without temporary protective ileostomy
Procedure: straight coloanal anastomosis
straight coloanal anastomosis with/without temporary protective ileostomy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238381

Contacts
Contact: Christian T. Hamel, MD +49 7621 416 8230 hamel.christian@klinloe.de
Contact: Walter R. Marti, Prof. +41 62 838 45 02 walter.r.marti@ksa.ch

Locations
Germany
Kreiskrankenhaus Lörrach Recruiting
Lörrach, Germany, 79539
Contact: Christian T. Hamel, MD    41-61-328-7731      
Principal Investigator: Christian T. Hamel, MD         
Switzerland
Kantonsspital Aarau Recruiting
Aarau, Switzerland, CH-5001
Contact: Contact Person    41-62-838-4425      
Principal Investigator: Walter R. Marti, MD         
Zuger Kantonsspital AG Completed
Baar, Switzerland, 6340
Universitaetsspital-Basel Completed
Basel, Switzerland, CH-4031
Inselspital Bern Recruiting
Bern, Switzerland, CH-3010
Contact: Contact Person    41-31-632-2477      
Principal Investigator: Beat Gloor, MD         
Kantonsspital Bruderholz Completed
Bruderholz, Switzerland, CH-4101
Bezirksspital Dornach Recruiting
Dornach, Switzerland, CH-4143
Contact: Contact Person    41-61-704-4227      
Principal Investigator: Peter Vogelbach, MD         
Hopital de La Chaux-de-Fonds Recruiting
La Chaux-de-Fonds, Switzerland, CH 2300
Contact: Contact Person    41-32-967-2532      
Principal Investigator: Charles Becciolini, MD         
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland, CH-1011
Contact: Contact Person    41-21-314-2350      
Principal Investigator: Henri Vuilleumier, MD         
Kantonsspital Luzern Recruiting
Luzerne, Switzerland, CH-6000
Contact: Contact Person    41-41-205-4862      
Principal Investigator: Urs Metzger, MD         
Ospedale Beata Vergine Recruiting
Mendrisio, Switzerland, CH-6850
Contact: Contact Person    41-91-811-3265      
Principal Investigator: Fabrizio Fasolini, MD         
Kantonsspital Olten Recruiting
Olten, Switzerland, CH-4600
Contact: Contact Person    41-62-311-4111      
Principal Investigator: Markus Zuber, MD         
Hopitaux Universitaires de Geneve Recruiting
Thonex-Geneve, Switzerland, CH-1226
Contact: Contact Person    41-22-372-3311      
Principal Investigator: Pascal Gervaz, MD         
GZO Spital Wetzikon Recruiting
Wetzikon, Switzerland, 8620
Contact: Contact Person    41-44-934-2201      
Principal Investigator: Ruedi Stieger, MD         
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, CH-8400
Contact: Contact Person    41-52-266-2402      
Principal Investigator: Emanuel Gmür, MD         
City Hospital Triemli Recruiting
Zurich, Switzerland, CH-8063
Contact: Contact Person    41-44-466-1111      
Principal Investigator: Urs Metzger, MD         
Klinik Hirslanden Recruiting
Zurich, Switzerland, CH-8032
Contact: Contact Person    41-44-387-3075      
Principal Investigator: Heinz Wehrli, MD         
UniversitaetsSpital Zuerich Completed
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00238381     History of Changes
Other Study ID Numbers: SAKK 40/04, EU-20528
Study First Received: October 12, 2005
Last Updated: December 8, 2013
Health Authority: Switzerland: Ethical Committees

Keywords provided by Swiss Group for Clinical Cancer Research:
adenocarcinoma of the rectum
stage 0 rectal cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases

ClinicalTrials.gov processed this record on April 17, 2014