Ten Versus Fifteen Centimeter Pouch in IPAA Surgery (TESTIMONY)

July 4, 2025 updated by: Odense University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Aarhus University Hospital
        • Contact:
      • Hvidovre, Denmark
        • Recruiting
        • Hvidovre Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 cm
Ileal reservoir length of 10 cm
Procedure: 10 cm pouch
A 10 cm pouch will be constructed
Active Comparator: 15 cm
Ileal reservoir length of 15 cm
Procedure: 15 cm pouch
A 15 cm pouch will be constructed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1, 3, 5 and 10 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Inflammatory Bowel Disease Questionnaire
Time Frame: 1, 3, 5 and 10 years after surgery
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)
1, 3, 5 and 10 years after surgery
Short-form (SF)-36
Time Frame: 1, 3, 5 and 10 years after surgery
Consists of questions relating to 8 domains of life with a total score ranging from 0-100, with lower numbers indicating worse health status
1, 3, 5 and 10 years after surgery
Postoperative complications using the Comprehensive Complication Index (CCI)
Time Frame: 90 days after surgery
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.
90 days after surgery
Pouch failure
Time Frame: 1, 3, 5 and 10 years after surgery
Hazard ratio of pouch failure defined as an intended permanent ileostomy with or without pouch excision
1, 3, 5 and 10 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2025

Primary Completion (Estimated)

July 3, 2028

Study Completion (Estimated)

July 3, 2038

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 4, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OP_2227

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcerative Colitis

Clinical Trials on 10 cm pouch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe