Rectal Cancer Trial On Defunctioning Stoma (RECTODES)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Rectal Cancer Trial On Defunctioning Stoma|
- 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 ]
- Reoperation within 30 days of initial surgery. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 1999|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
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.
|Department of Surgery, Linköping University Hospital|
|Linköping, Sweden, 581 85|
|Study Chair:||Rune Sjödahl, MD, PhD||Department of Surgery, Linköping University Hospital|