Rectal Cancer Trial On Defunctioning Stoma (RECTODES)

This study has been completed.
Sponsor:
Information provided by:
Rectal Cancer Trial on Defunctioning Stoma Study Group
ClinicalTrials.gov Identifier:
NCT00636948
First received: February 11, 2008
Last updated: March 10, 2008
Last verified: March 2008
  Purpose

The hypothesis of the present trial was that the use of a defunctioning loop stoma reduces the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of the rectum for cancer.


Condition
Rectal Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Rectal Cancer Trial On Defunctioning Stoma

Resource links provided by NLM:


Further study details as provided by Rectal Cancer Trial on Defunctioning Stoma Study Group:

Primary Outcome Measures:
  • Symptomatic anastomotic leakage following low anterior resection of the rectum for cancer with and without a defunctioning stoma. Anorectal function after one and five years without defunctioning stoma. [ Time Frame: 30 days, one year and five years. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reoperation within 30 days of initial surgery. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 234
Study Start Date: December 1999
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Detailed Description:

The assumption that a defunctioning loop stoma reduces symptomatic anastomotic leakage from 15% to 7.5%, with a level of statistical significance of 5% and a statistical power of 80%, requires randomization of 220 patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients operated for rectal cancer in whom low anteriror resection with or without preoperative adjuvant treatment was the planned treatment, who did not have any intraoperative adverse events and who had accepted participation.

Criteria

Inclusion Criteria:

  • Absence of intraoperative adverse events according to the study protocol and the operating surgeon.

Exclusion Criteria:

  • Presence of intraoperative adverse events according to the study protocol and the operating surgeon.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636948

Locations
Sweden
Department of Surgery, Linköping University Hospital
Linköping, Sweden, 581 85
Sponsors and Collaborators
Rectal Cancer Trial on Defunctioning Stoma Study Group
Investigators
Study Chair: Rune Sjödahl, MD, PhD Department of Surgery, Linköping University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Matthiessen, MD, PhD, Department of Surgery, Örebro University Hospital
ClinicalTrials.gov Identifier: NCT00636948     History of Changes
Other Study ID Numbers: Dnr 99039
Study First Received: February 11, 2008
Last Updated: March 10, 2008
Health Authority: Sweden: Institutional Review Board

Keywords provided by Rectal Cancer Trial on Defunctioning Stoma Study Group:
Rectal cancer surgery
Symptomatic anastomotic leakage
Defunctioning stoma
TME surgery

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

ClinicalTrials.gov processed this record on April 17, 2014