Ten Versus Fifteen Centimeter Pouch in IPAA Surgery
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: 10 cm pouch, 15 cm pouch.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis, Familial Adenomatous Polyposis. Basic parameters: 18 years — 60 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
- Denmark
- 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
Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis
Overview
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.
Interventions
- Procedure 10 cm pouch
A 10 cm pouch will be constructed - Procedure 15 cm pouch
A 15 cm pouch will be constructed
Primary outcome measures
- Pouch dysfunction score [Time frame: 1, 3, 5 and 10 years after surgery]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
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
- Double blind
- Primary purpose
- Treatment
Study locations
Denmark · 2 centers
- Aarhus University Hospital — Aarhus
- Hvidovre Hospital — Hvidovre
Identifiers
NCT: NCT06538402 · OP_2227