Ten Versus Fifteen Centimeter Pouch in IPAA Surgery
Not applicable · Testing 10 cm pouch and 15 cm pouch · 2 sites · Odense University Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing 10 cm pouch (a procedure) and 15 cm pouch (a procedure) as a possible treatment. Condition(s) listed: Ulcerative Colitis and Familial Adenomatous Polyposis.
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 60
- Any sex
Some of the main requirements, copied from the record:
- 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
Only the trial team can confirm whether you qualify.
What's involved
- About 120 participants are expected to take part.
- Start date: 2025-07-03.
- Main results expected around 2028-07-03 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in Denmark.
Main thing being measured
- Pouch dysfunction score (1, 3, 5 and 10 years after surgery)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis; Familial Adenomatous Polyposis |
| Lead sponsor | Odense University Hospital |
| Enrollment | 120 (estimated) |
| Start date | 2025-07-03 |
| Primary completion (est.) | 2028-07-03 |
| First posted | 2024-08-05 |
| Last updated | 2025-07-09 |
| Official title | Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis |
| ClinicalTrials.gov ID | NCT06538402 |
Interventions
- 10 cm pouch (Procedure)
A 10 cm pouch will be constructed - 15 cm pouch (Procedure)
A 15 cm pouch will be constructed
Full eligibility criteria (from the record)
Inclusion Criteria: * 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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital | Aarhus | Denmark | Recruiting |
| Hvidovre Hospital | Hvidovre | Denmark | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.