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

This study has been completed.
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research Identifier:
First received: October 12, 2005
Last updated: August 11, 2016
Last verified: August 2016

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
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

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 ]

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 ]
  • 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 ]

Enrollment: 336
Study Start Date: July 2005
Study Completion Date: August 2016
Primary Completion Date: May 2014 (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
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00238381

Kreiskrankenhaus Lörrach
Lörrach, Germany, 79539
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
Zuger Kantonsspital AG
Baar, Switzerland, 6340
Basel, Switzerland, CH-4031
Inselspital Bern
Bern, Switzerland, CH-3010
Kantonsspital Bruderholz
Bruderholz, Switzerland, CH-4101
Bezirksspital Dornach
Dornach, Switzerland, CH-4143
Hopital de La Chaux-de-Fonds
La Chaux-de-Fonds, Switzerland, CH 2300
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Kantonsspital Luzern
Luzerne, Switzerland, CH-6000
Ospedale Beata Vergine
Mendrisio, Switzerland, CH-6850
Kantonsspital Olten
Olten, Switzerland, CH-4600
Hopitaux Universitaires de Geneve
Thonex-Geneve, Switzerland, CH-1226
GZO Spital Wetzikon
Wetzikon, Switzerland, 8620
Kantonsspital Winterthur
Winterthur, Switzerland, CH-8400
Klinik Hirslanden
Zurich, Switzerland, CH-8032
City Hospital Triemli
Zurich, Switzerland, CH-8063
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
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

Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00238381     History of Changes
Other Study ID Numbers: SAKK 40/04
Study First Received: October 12, 2005
Last Updated: August 11, 2016

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:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases processed this record on April 24, 2017