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

July 21, 2026 updated by: Darrell S. Pardi, M.D., Mayo Clinic

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

AIMS:

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

Study Type

Interventional

Enrollment (Actual)

66

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 Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with Pouchitis
Transabdominal and trans perianal ultrasounds of the pouch will be performed by an experienced sonographer for each patient and interpreted by a board-certified radiologist specializing in IUS.
Diagnostic test: Intestinal Ultrasound
Transabdominal and trans perineal ultrasound of the pouch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy of Intestinal Ultrasound (IUS) to Evaluate for Pouchitis Findings, Post Ileal Pouch-Anal Anastomosis-Number of Participants With Abnormal Ultrasound Findings
Time Frame: 2 hours per subject for ultrasound.
Radiologists were blinded to pouchoscopy with biopsy results and evaluated the intestinal ultrasound of the pouch for each patient; assessing whether normal healthy pouch or inflammation was present. Those results were then compared to gold standard of pouchoscopy with biopsies to confirm accuracy. The number (n(%)) of participants with abnormal ultrasound findings confirmed with gold standard are reported.
2 hours per subject for ultrasound.

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Darrell Pardi, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 1, 2024

Primary Completion (Actual)

June 4, 2025

Study Completion (Actual)

December 4, 2025

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-012169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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.

Subscribe