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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00238381
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : May 15, 2019
Information provided by (Responsible Party):
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2005
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2016

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Composite evacuation score after total mesorectal excision [ Time Frame: 12 months after surgery ]

Secondary Outcome Measures :
  1. Composite evacuation score at 6, 18, and 24 months after total mesorectal excision [ Time Frame: 6, 18 and 24 months after surgery ]
  2. Composite incontinence score after total mesorectal excision [ Time Frame: 6, 12, 18 and 24 months ]
  3. Quality of life after total mesorectal excision [ Time Frame: 6, 12m 18 and 24 months ]
  4. Overall survival [ Time Frame: 2 years follow-up ]
  5. Morbidity [ Time Frame: 2 years follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00238381

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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
Hopitaux Universitaires de Geneve
Geneva, Switzerland, CH-1226
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
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
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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 of Results:
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Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00238381     History of Changes
Other Study ID Numbers: SAKK 40/04
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
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:
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Colorectal Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases