Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Loop ileostomy, Loop colostomy.
- Who it may be relevant to
- Registry conditions: Stoma Colostomy, Stoma Ileostomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PROtective ileoStomy Versus ProtectivE Colostomy in Anterior Rectal resectIon - a Multicenter, Open-label, Randomized conTrolled studY (PROSPERITY)
Overview
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)).
Interventions
- Procedure Loop ileostomy
Patient undergoing anterior rectal resection will receive loop ileostomy - Procedure Loop colostomy
Patient undergoing anterior rectal resection will receive loop colostomy
Primary outcome measures
- Stoma-related adverse events [Time frame: Within 60 days from randomization]
Secondary outcome measures (5)
- Postoperative complications [Time frame: Within 30 days from randomization]
- Postoperative complications after stoma closure [Time frame: Within 30 days from stoma closure]
- Hospital-free days [Time frame: Within 30 days from randomization]
- Quality of life [Time frame: At 2 months from randomization]
- Kidney function change [Time frame: Within 1 year from randomization]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Finland · 3 centers
- Helsinki University Hospital — Helsinki
- Tampere University Hospital — Tampere
- Turku University Hospital — Turku
Publications
- Koskenvuo L, Paajanen P, Varpe P, Seppala T, Mentula P, Haapamaki C, Carpelan-Holmstrom M, Carpelan A, Lehto K, Satokari R, Lepisto A, Sallinen V. PROtective ileoStomy versus ProtectivE colostomy in anterior Rectal resectIon: study protocol for a multicenter, open-label, randomised conTrolled studY (PROSPERITY). BMJ Open. 2025 May 6;15(5):e096091. doi: 10.1136/bmjopen-2024-096091. PMID 40335149
Identifiers
NCT: NCT06650085 · PROSPERITY