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NCT Number: NCT06538402

Ten Versus Fifteen Centimeter Pouch in IPAA Surgery

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.

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Key information

Conditions

Ulcerative Colitis Adenoma Adenomatous Polyposis Coli Adenomatous Polyps Colitis Colitis, Ulcerative Colonic Diseases Colorectal Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms Familial Adenomatous Polyposis Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Intestinal Polyposis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Syndromes, Hereditary

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10 cm pouch

Procedure

A 10 cm pouch will be constructed

15 cm pouch

Procedure

A 15 cm pouch will be constructed

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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.

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anders Mark-Christensen, MD, PhD

CONTACT

[email protected]

+45 51236691

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis

Acronym: TESTIMONY

Important dates

Study start
2025
Primary completion
2028
Study completion
2038
First posted
Aug 5, 2024
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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