Ten Versus Fifteen Centimeter Pouch in IPAA Surgery

NCT ID: NCT06538402

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-03

Study Completion Date

2038-07-03

Brief Summary

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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

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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

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Ulcerative Colitis Familial Adenomatous Polyposis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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10 cm

Ileal reservoir length of 10 cm

Group Type EXPERIMENTAL

10 cm pouch

Intervention Type PROCEDURE

A 10 cm pouch will be constructed

15 cm

Ileal reservoir length of 15 cm

Group Type ACTIVE_COMPARATOR

15 cm pouch

Intervention Type PROCEDURE

A 15 cm pouch will be constructed

Interventions

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10 cm pouch

A 10 cm pouch will be constructed

Intervention Type PROCEDURE

15 cm pouch

A 15 cm pouch will be constructed

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Hvidovre Hospital

Hvidovre, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Anders Mark-Christensen, MD, PhD

Role: CONTACT

+45 51236691

Facility Contacts

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Sanne Harsløf, MD PhD

Role: primary

Frederik Rønne Pachler, MD PhD

Role: primary

Other Identifiers

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OP_2227

Identifier Type: -

Identifier Source: org_study_id

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