Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis

Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA).

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Enteritis Gastroenteritis Gastrointestinal Diseases Ileal Diseases Ileitis Inflammatory Bowel Diseases Intestinal Diseases Pouchitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

AIMS:

Establish normal sonographic parameters in patients with an IPAA and normal pouch function.
Evaluate the feasibility of IUS for diagnosing pouchitis and other outcomes and compare its performance with the current gold standard of pouchoscopy with biopsies.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Adults (age ≥ 18 years)
Diagnosis of ulcerative colitis (UC)
Status post ileal pouch anal anastomosis IPAA (completed all stages)

Exclusion criteria

Pediatric patients
Indeterminate colitis
Status post IPAA for familial adenomatous polyposis (FAP)
BMI > 30 kg/m2
Pregnant
Decompensated Cirrhosis
Inability to provide informed consent

Treatment and study plan

Intestinal ultrasound

Diagnostic Test

Transabdominal and trans perineal ultrasound of the pouch

Primary outcomes

Diagnostic accuracy of intestinal ultrasound (IUS) for pouchitis

Time frame: through study completion, an average of 1 year

compared to gold standard of pouchoscopy with biopsies

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Utility of Intestinal Ultrasound as a Diagnostic Tool for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis: A Prospective Pilot Study

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Mar 19, 2024
Registry last updated: Jun 8, 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.

Published trials that share one or more normalized conditions with this study.

Completed