Protective ileostomy vs protective colostomy after anterior rectal resection
Official title: PROtective ileoStomy Versus ProtectivE Colostomy in Anterior Rectal resectIon - a Multicenter, Open-label, Randomized conTrolled studY (PROSPERITY)
Run by Helsinki University Central Hospital · NCT06650085 · Data updated 2026-11-12
This study tests whether a loop ileostomy or a loop colostomy works better as a protective stoma after anterior rectal resection in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 3 sites (Helsinki and 2 other locations) |
| Status | Recruiting |
| Started | October 6, 2025 |
| Main results expected | October 2028 |
| Study ends | October 2033 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT06650085 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults undergoing anterior rectal resection with a planned protective stoma and no preexisting stoma or conditions that would prevent ileostomy or colostomy creation.
✕Probably not a fit
Patients who do not experience stoma-related complications or who do not fit the randomized assignment may not derive a detectable benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, open-label trial randomly assigns patients undergoing anterior rectal resection with a planned protective stoma to either a loop ileostomy or a loop colostomy. It aims to determine which approach results in fewer stoma-related adverse events within 60 days after the first surgery, using the Comprehensive Complication Index to measure complications. Participants are randomized intraoperatively in a 1:1 ratio and followed for postoperative outcomes. The study operates under a superiority framework across several Finnish centers with collaboration from Helsinki University Central Hospital and partner institutions. Data on safety and postoperative recovery will inform whether one stoma type offers a clear advantage over the other.
Why it matters
Potential benefit: If one approach shows fewer complications, patients may experience smoother recovery and fewer stoma-related issues.
How similar studies have gone: Evidence from prior work is limited on the relative benefits of loop ileostomy versus loop colostomy; this trial addresses a knowledge gap with an approach similar to other randomized comparative stoma trials but remains relatively novel in its direct comparison.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Helsinki University Hospital
Helsinki, Finland Recruiting -
Tampere University Hospital
Tampere, Finland Recruiting -
Turku University Hospital
Turku, Finland Recruiting
Study contacts
- Principal investigator: Ville Sallinen, MD, PhD — Helsinki University Central Hospital
- Study coordinator: Laura Koskenvuo, MD, PhD
- Email: laura.koskenvuo@hus.fi
- Phone: +358-9-4711
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Midline Stoma Outcomes
This study tests outcomes for temporary ileostomies or colostomies placed through the midline incision to see how patients fare after stoma reversal.
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Drug absorption in people with an ostomy
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Efferent loop stimulation before ileostomy closure
This study is testing if stimulating a part of the intestine with a special solution before closing an ileostomy can help patients recover better and have fewer complications after surgery.
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Intensified omeprazole treatment to reduce high-output stoma in ileostomy patients
This study tests if a stronger dose of omeprazole can help adults with ileostomy surgery have less stoma output and stay out of the hospital longer.
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Training program for patients with permanent colostomies to improve self-efficacy
This study tests a training program for people with permanent colostomies to see if it helps them feel more confident and better manage their condition.
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Evaluating the Heylo™ device for people with stomas
This study is testing a new device that helps people with stomas by sending alerts to their phones when there are changes in their stoma bag, to see if it can reduce leaks and improve their daily life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.