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Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection
Sponsor: Helsinki University Central Hospital
Summary
Loop ileostomy and loop colostomy are both used as protective stomas after anterior resection. There is a lack of evidence on the superiority of loop ileostomy versus loop colostomy. This is a multicenter, open-label, superiority, individually randomized controlled trial including patients undergoing anterior rectal resection with primary anastomosis and a protective stoma. Patients scheduled for anterior rectal resection are randomized 1:1 to loop ileostomy or loop colostomy intraoperatively. Primary outcome is cumulative stoma-related adverse events within 60 days post-primary surgery (scored using Comprehensive Complication Index (CCI)).
Official title: PROtective IleoStomy Versus ProtectivE Colostomy in Anterior Rectal ResectIon - a Multicenter, Open-label, Randomized ConTrolled StudY (PROSPERITY)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2024-10
Completion Date
2032-10
Last Updated
2024-10-21
Healthy Volunteers
No
Conditions
Interventions
Loop ileostomy
Patient undergoing anterior rectal resection will receive loop ileostomy
Loop colostomy
Patient undergoing anterior rectal resection will receive loop colostomy
Locations (3)
Helsinki University Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland