Ulcerative ColitisTESTIMONYNCT06538402
Ten Versus Fifteen Centimeter Pouch in IPAA Surgery
A study testing 10 cm pouch and 15 cm pouch in people with Ulcerative Colitis and Familial Adenomatous Polyposis, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
The aim of this randomized controlled trial is to compare outcome after construction of an ileal (J-shaped) reservoir of 10 versus 15 centimeters in primary ileal pouch-anal anastomosis surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ulcerative Colitis, Familial Adenomatous Polyposis
- What is being tested?
- 10 cm pouch and 15 cm pouch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesDenmark
- Study dates
- 3 Jul 2025to 3 Jul 2038
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Undergoing ileal pouch-anal anastomosis (IPAA) for ulcerative colitis or familial adenomatous polyposis (FAP) (implying a normal sphincter function as judged by history and clinical examination)
- Signed informed consent
- Able to perform both a small (10 cm) and medium-size (15 cm) pouch with adequate reach and no tension as determined subjectively by the surgeon intraoperatively
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
Sanne Harsløf, MD PhD, sanne.harslof@rm.dk
- Recruiting
Hvidovre Hospital
Hvidovre
Frederik Rønne Pachler, MD PhD, fpachler@gmail.com
About this study
Official title: Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis
The aim of this randomized controlled trial is to compare outcome after construction of an ileal (J-shaped) reservoir of 10 versus 15 centimeters in primary ileal pouch-anal anastomosis surgery.
Read the detailed description
The primary aim of this randomized controlled trial is to compare functional outcome in terms of bowel function correlated with quality of life for patients who undergo primary ileal pouch-anal anastomosis surgery with an ileal (J-shaped) reservoir length of either 10 cm or 15 cm.
Secondary aims include health-related quality of life measures and postoperative complications.
- Conditions
- Ulcerative Colitis, Familial Adenomatous Polyposis
- Being tested
- 10 cm pouch, 15 cm pouch
- Keywords
- ileal pouch-anal anastomosis, ulcerative colitis, familial adenomatous polyposis, randomized controlled trial, pouch function, quality of life, complications
- Medical subject headings
- Colitis, Ulcerative, Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 cm pouchProcedure or surgery
A 10 cm pouch will be constructed
15 cm pouchProcedure or surgery
A 15 cm pouch will be constructed
| Study group | Role | What they receive |
|---|---|---|
| 10 cm | Experimental | Ileal reservoir length of 10 cm Receives: Procedure: 10 cm pouch |
| 15 cm | Active comparator | Ileal reservoir length of 15 cm Receives: Procedure: 15 cm pouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pouch dysfunction score
Ranges from 0 to 7.5, where a low score indicates good bowel function will little to no impact on quality of life
Measured: 1, 3, 5 and 10 years after surgery
Secondary outcomes (4)
Short Inflammatory Bowel Disease Questionnaire
Consists of 10 questions with a total score range from 10 (poor health-related quality of life) to 70 (good health-related quality of life)
Measured: 1, 3, 5 and 10 years after surgery
Short-form (SF)-36
Consists of questions relating to 8 domains of life with a total score ranging from 0-100, with lower numbers indicating worse health status
Measured: 1, 3, 5 and 10 years after surgery
Postoperative complications using the Comprehensive Complication Index (CCI)
The CCI is a continuous scale, where each postoperative complication as defined by Clavien-Dindo is assigned a weigth based on its severity. A total summarized score taking all complications into account is thus generated.
Measured: 90 days after surgery
Pouch failure
Hazard ratio of pouch failure defined as an intended permanent ileostomy with or without pouch excision
Measured: 1, 3, 5 and 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start3 Jul 2025
- Primary completion3 Jul 2028 (estimated)
- Study completion3 Jul 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Odense University 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538402
- Sponsor's protocol ID
- OP_2227
- Acronym
- TESTIMONY
- Status last verified
- Jul 2025
- First submitted
- 1 Aug 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis
- ClinicalTrials.gov ID
- NCT06538402
- Acronym / sponsor ID
- TESTIMONY / OP_2227
- Conditions
- Ulcerative Colitis, Familial Adenomatous Polyposis
- Keywords
- ileal pouch-anal anastomosis, ulcerative colitis, familial adenomatous polyposis, randomized controlled trial, pouch function, quality of life, complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 3 Jul 2028 (estimated)
- Study completion
- 3 Jul 2038 (estimated)
- First posted
- 5 Aug 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.
The aim of this randomized controlled trial is to compare outcome after construction of an ileal (J-shaped) reservoir of 10 versus 15 centimeters in primary ileal pouch-anal anastomosis surgery.
Detailed description
The primary aim of this randomized controlled trial is to compare functional outcome in terms of bowel function correlated with quality of life for patients who undergo primary ileal pouch-anal anastomosis surgery with an ileal (J-shaped) reservoir length of either 10 cm or 15 cm.
Secondary aims include health-related quality of life measures and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 cm | Experimental | Procedure: 10 cm pouchIleal reservoir length of 10 cm |
| 15 cm | Active comparator | Procedure: 15 cm pouchIleal reservoir length of 15 cm |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Undergoing ileal pouch-anal anastomosis (IPAA) for ulcerative colitis or familial adenomatous polyposis (FAP) (implying a normal sphincter function as judged by history and clinical examination)
- Signed informed consent
- Able to perform both a small (10 cm) and medium-size (15 cm) pouch with adequate reach and no tension as determined subjectively by the surgeon intraoperatively
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 10 cm pouchA 10 cm pouch will be constructed | Procedure or surgery | 10 cm |
| 15 cm pouchA 15 cm pouch will be constructed | Procedure or surgery | 15 cm |
Primary outcome
Pouch dysfunction score
Time frame: 1, 3, 5 and 10 years after surgery
Ranges from 0 to 7.5, where a low score indicates good bowel function will little to no impact on quality of life
4 secondary outcomes
Short Inflammatory Bowel Disease Questionnaire
Time frame: 1, 3, 5 and 10 years after surgery
Short-form (SF)-36
Time frame: 1, 3, 5 and 10 years after surgery
Postoperative complications using the Comprehensive Complication Index (CCI)
Time frame: 90 days after surgery
Pouch failure
Time frame: 1, 3, 5 and 10 years after surgery
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 Jul 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 cm pouch and 15 cm pouch in people with Ulcerative Colitis and Familial Adenomatous Polyposis, run by Odense University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. 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 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 Anders Mark-Christensen, MD, PhD (+45 51236691, anders.mark.christensen2@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pouch dysfunction score (time frame: 1, 3, 5 and 10 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2025.