Clinical trial NCT06650085: Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection
Official title: PROtective IleoStomy Versus ProtectivE Colostomy in Anterior Rectal ResectIon - a Multicenter, Open-label, Randomized ConTrolled StudY (PROSPERITY)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stoma Colostomy
Stoma Ileostomy
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Mary and Georg Ehrnrooth's foundation
name: Helsinki University Hospital Research Funds
First posted: 2024-10-21
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)).


Eligibility criteria: Inclusion Criteria: Patients undergoing anterior resection (resection of the rectum and colorectal or coloanal anastomosis) due to a rectal tumour and a protective stoma is planned.

The exclusion criteria are: (1) patient already having a stoma (or another stoma made during surgery), (2) technical inability to create ileo- or colostomy (e.g. previous bowel resection, anatomical factors), (3) age \<18 years, (4) inadequate ability to co-operate.

Primary outcomes:
measure: Stoma-related adverse events
timeFrame: Within 60 days from randomization
Secondary outcomes:
measure: Postoperative complications
timeFrame: Within 30 days from randomization
measure: Postoperative complications after stoma closure
timeFrame: Within 30 days from stoma closure
measure: Hospital-free days
timeFrame: Within 30 days from randomization
measure: Quality of life
timeFrame: At 2 months from randomization
measure: Kidney function change
timeFrame: Within 1 year from randomization
Other outcomes:
measure: 5-year overall survival
timeFrame: Within 5 years from randomization
measure: 5-year disease-free survival
timeFrame: Within 5 years from randomization
measure: Kidney function change at 5 years
timeFrame: Within 5 years from randomization
measure: Incisional hernia
timeFrame: Within 5 years from randomization
measure: Stoma closure
timeFrame: Within 5 years from randomization
measure: Quality of life at 5 years
timeFrame: At 5 years from randomization
measure: Quality of life at 5 years
timeFrame: At 5 years from randomization
measure: Quality of life at 5 years
timeFrame: At 5 years from randomization
measure: Quality of life at 1 year
timeFrame: At 1 year from randomization
measure: Quality of life at 6 months
timeFrame: At 6 months from randomization
measure: Quality of life at 1 year
timeFrame: At 1 year from randomization
measure: Quality of life at 6 months
timeFrame: At 6 months from randomization
measure: Quality of life at 2 months
timeFrame: At 2 months from randomization
measure: Quality of life at 1 year
timeFrame: At 1 year from randomization
measure: Quality of life at 6 months
timeFrame: At 6 months from randomization
measure: Anastomotic leakage
timeFrame: Within 60 days from randomization
measure: Intestinal microbiome
timeFrame: Within 5 years from randomization
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Ville Sallinen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: