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Rectal Cancer Trial On Defunctioning Stoma (RECTODES)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00636948
First Posted: March 17, 2008
Last Update Posted: March 17, 2008
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.
Information provided by:
Rectal Cancer Trial on Defunctioning Stoma Study Group
  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

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. ]

Secondary Outcome Measures:
  • Reoperation within 30 days of initial surgery. [ Time Frame: 30 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: February 11, 2008
First Posted: March 17, 2008
Last Update Posted: March 17, 2008
Last Verified: March 2008

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