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PROtective IleoStomy Versus ProtectivE Colostomy in Anterior Rectal ResectIon - a Multicenter, Open-label, Randomized ConTrolled StudY (PROSPERITY)
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)).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Helsinki University Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Start Date
October 1, 2024
Primary Completion Date
October 1, 2027
Completion Date
October 1, 2032
Last Updated
October 21, 2024
350
ESTIMATED participants
Loop ileostomy
PROCEDURE
Loop colostomy
PROCEDURE
Lead Sponsor
Helsinki University Central Hospital
Collaborators
NCT07138326
NCT06344078
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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