Rectal Cancer Trial On Defunctioning Stoma
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Rectal Cancer
Both
Rectal Cancer
Trial Information
Rectal Cancer Trial On Defunctioning Stoma
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.
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.
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
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.
Outcome Time Frame:
30 days, one year and five years.
Safety Issue:
Yes
Principal Investigator
Rune Sjödahl, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Department of Surgery, Linköping University Hospital
Authority:
Sweden: Institutional Review Board
Study ID:
Dnr 99039
NCT ID:
NCT00636948
Start Date:
December 1999
Completion Date:
Related Keywords:
- Rectal Cancer
- Rectal cancer surgery
- Symptomatic anastomotic leakage
- Defunctioning stoma
- TME surgery
- Rectal Neoplasms
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