Rectal Cancer Trial On Defunctioning Stoma

Rectal Cancer Clinical Trial

— RECTODES  

Official title:

Rectal Cancer Trial On Defunctioning Stoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636948
• Other study ID #: Dnr 99039
• Status: Completed
• Phase: N/A
• First received: February 11, 2008
• Last updated: March 10, 2008
• Start date: December 1999

Study information

• Verified date: March 2008
• Source: Rectal Cancer Trial on Defunctioning Stoma Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
Sweden	Department of Surgery, Linköping University Hospital	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Rectal Cancer Trial on Defunctioning Stoma Study Group

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Matthiessen P, Hallböök O, Rutegård J, Simert G, Sjödahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		30 days, one year and five years.	Yes
Secondary	Reoperation within 30 days of initial surgery.		30 days	Yes