Stoma ColostomyPROSPERITYNCT06650085
Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection
A study testing Loop ileostomy and Loop colostomy in people with Stoma Colostomy and Stoma Ileostomy, run by Helsinki University Central Hospital at 3 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Colostomy, Stoma Ileostomy
- What is being tested?
- Loop ileostomy and Loop colostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 3 sitesFinland
- Study dates
- 6 Oct 2025to Oct 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland3 sites, 3 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Laura Koskenvuo, MD, PhD, laura.koskenvuo@hus.fi
- Recruiting
Tampere University Hospital
Tampere
Toni Seppälä, MD, PhD, toni.seppala@tuni.fi
- Recruiting
Turku University Hospital
Turku
Pirita Varpe, MD, PhD, pirita.varpe@tyks.fi
About this study
Official title: 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)).
- Conditions
- Stoma Colostomy, Stoma Ileostomy
- Being tested
- Loop ileostomy, Loop colostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loop ileostomyProcedure or surgery
Patient undergoing anterior rectal resection will receive loop ileostomy
Loop colostomyProcedure or surgery
Patient undergoing anterior rectal resection will receive loop colostomy
| Study group | Role | What they receive |
|---|---|---|
| Loop ileostomy | Experimental | Not described Receives: Procedure: Loop ileostomy |
| Loop colostomy | Active comparator | Not described Receives: Procedure: Loop colostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stoma-related adverse events
Stoma-related adverse events score by using Comprehensive Complication Index
Measured: Within 60 days from randomization
Secondary outcomes (5)
Postoperative complications
All complications scored using Comprehensive Complication Index
Measured: Within 30 days from randomization
Postoperative complications after stoma closure
All complications after stoma closure using Comprehensive Complication Index (including only patients who have undergone stoma closure within 1 year from primary surgery)
Measured: Within 30 days from stoma closure
Hospital-free days
Days patient is alive and out of any hospital
Measured: Within 30 days from randomization
Quality of life
Quality of life measured using EORTC Quality of life questionnaires core 30 with colorectal 29 extension (QLQ-C30+QLQ-CR29)
Measured: At 2 months from randomization
Kidney function change
Kidney function change defined as difference in eGFR before and 1 year after randomization
Measured: Within 1 year from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start6 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stoma ColostomyStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mary and Georg Ehrnrooth's foundation, Helsinki University Hospital Research Funds
- Responsible party
- Principal investigator, Ville Sallinen, Helsinki University Central Hospital
- Investigators
- Ville Sallinen, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650085
- Sponsor's protocol ID
- PROSPERITY
- Acronym
- PROSPERITY
- Status last verified
- Jun 2026
- First submitted
- 20 Aug 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40335149
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROtective ileoStomy Versus ProtectivE Colostomy in Anterior Rectal resectIon - a Multicenter, Open-label, Randomized conTrolled studY (PROSPERITY)
- ClinicalTrials.gov ID
- NCT06650085
- Acronym / sponsor ID
- PROSPERITY / PROSPERITY
- Conditions
- Stoma Colostomy, Stoma Ileostomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Mary and Georg Ehrnrooth's foundation, Helsinki University Hospital Research Funds
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2033 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loop ileostomy | Experimental | Procedure: Loop ileostomy |
| Loop colostomy | Active comparator | Procedure: Loop colostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loop ileostomyPatient undergoing anterior rectal resection will receive loop ileostomy | Procedure or surgery | Loop ileostomy |
| Loop colostomyPatient undergoing anterior rectal resection will receive loop colostomy | Procedure or surgery | Loop colostomy |
Primary outcome
Stoma-related adverse events
Time frame: Within 60 days from randomization
Stoma-related adverse events score by using Comprehensive Complication Index
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Derived from this study: PubMed 40335149Koskenvuo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ville Sallinen, MD, PhD principal investigator
Helsinki University Central Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loop ileostomy and Loop colostomy in people with Stoma Colostomy and Stoma Ileostomy, run by Helsinki University Central Hospital at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Koskenvuo, MD, PhD (+358-9-4711, laura.koskenvuo@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stoma-related adverse events (time frame: Within 60 days from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06650085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.