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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00238381
First received: October 12, 2005
Last updated: May 26, 2014
Last verified: May 2014
  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 ]

Enrollment: 336
Study Start Date: July 2005
Estimated Study Completion Date: December 2015
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
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
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 ClinicalTrials.gov identifier: NCT00238381

Locations
Germany
Kreiskrankenhaus Lörrach
Lörrach, Germany, 79539
Switzerland
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
Zuger Kantonsspital AG
Baar, Switzerland, 6340
Universitaetsspital-Basel
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
City Hospital Triemli
Zurich, Switzerland, CH-8063
Klinik Hirslanden
Zurich, Switzerland, CH-8032
UniversitaetsSpital Zuerich
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: May 26, 2014
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:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 16, 2014