Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT06538402

Ten Versus Fifteen Centimeter Pouch in IPAA Surgery

Led by Odense University Hospital · Updated on 2025-07-09

120

Participants Needed

2

Research Sites

678 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Ten Versus Fifteen Centimeter Pouch in IPAA Surgery

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing ileal pouch-anal anastomosis (IPAA) for ulcerative colitis or familial adenomatous polyposis (FAP) with normal sphincter function as judged by history and clinical examination
  • Signed informed consent
  • Able to have both a 10 cm and 15 cm pouch constructed with adequate reach and no tension as determined by the surgeon during surgery
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Aarhus University Hospital

Aarhus, Denmark

Actively Recruiting

2

Hvidovre Hospital

Hvidovre, Denmark

Actively Recruiting

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Research Team

A

Anders Mark-Christensen, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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