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

Mayo Clinic55 enrolled

Overview

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).

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Ulcerative Colitis Pouchitis

Interventions

Intestinal UltrasoundDIAGNOSTIC_TEST

Transabdominal and trans perineal ultrasound of the pouch

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Diagnostic accuracy of intestinal ultrasound (IUS) for pouchitis

compared to gold standard of pouchoscopy with biopsies

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

Data from ClinicalTrials.gov

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