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Rectal Cancer Trial On Defunctioning Stoma (RECTODES)

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ClinicalTrials.gov Identifier: NCT00636948
Recruitment Status : Completed
First Posted : March 17, 2008
Last Update Posted : March 17, 2008
Sponsor:
Information provided by:
Rectal Cancer Trial on Defunctioning Stoma Study Group

Brief Summary:
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 or disease
Rectal Cancer

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.

Study Type : Observational
Actual Enrollment : 234 participants
Time Perspective: Prospective
Official Title: Rectal Cancer Trial On Defunctioning Stoma
Study Start Date : December 1999
Actual Primary Completion Date : June 2005



Primary Outcome Measures :
  1. 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 :
  1. Reoperation within 30 days of initial surgery. [ Time Frame: 30 days ]


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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.

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

Publications of Results:
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 Posted: March 17, 2008    Key Record Dates
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