An observational study in Rectal Cancer, sponsored by Rectal Cancer Trial on Defunctioning Stoma Study Group. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-03-17.
Sponsored by Rectal Cancer Trial on Defunctioning Stoma Study Group · Observational
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.
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 234 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Rectal Cancer Trial on Defunctioning Stoma Study Group is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Reoperation within 30 days of initial surgery.
Time frame: 30 days
This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.
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Rectal Cancer Trial on Defunctioning Stoma Study Group