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

Last updated: August 9, 2024
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Ulcers

Inflammatory Bowel Disease

Treatment

Intestinal Ultrasound

Clinical Study ID

NCT06316999
23-012169
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults (age ≥ 18 years)

  • Diagnosis of ulcerative colitis (UC)

  • Status post ileal pouch anal anastomosis IPAA (completed all stages)

Exclusion

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 Design

Total Participants: 109
Treatment Group(s): 1
Primary Treatment: Intestinal Ultrasound
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.