NCT06316999

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

• Ulcerative Colitis
• Pouchitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Intestinal Ultrasound	Transabdominal and trans perineal ultrasound of the pouch

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-06-04
• Completion: 2025-06-04
• First posted: 2024-03-19
• Last updated: 2025-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study