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

Mayo Clinic

Status: Enrolling

Conditions: Pouchitis; Ulcerative Colitis

Treatments: Diagnostic Test: Intestinal Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06316999

23-012169

Details and patient eligibility

About

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).

Full 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.

Enrollment: 109 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 1 patient group

Patients with Pouchitis

Other group

Description:

Transabdominal and transperineal ultrasounds of the pouch will be performed by an experienced sonographer for each patient and interpreted by a board-certified radiologist specializing in IUS.

Treatment:

Diagnostic Test: Intestinal Ultrasound