Using intestinal ultrasound to evaluate pouchitis after surgery for ulcerative colitis
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
NA · Mayo Clinic · NCT06316999
This study is testing if using intestinal ultrasound can help doctors check for pouchitis in patients who have had surgery for ulcerative colitis, compared to the usual method of using a camera.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 109 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06316999 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of intestinal ultrasound (IUS) as a non-invasive tool for evaluating pouchitis and other outcomes in patients who have undergone ileal pouch-anal anastomosis (IPAA) due to ulcerative colitis. The research will establish normal ultrasound parameters for patients with a functioning pouch and compare the diagnostic capabilities of IUS against the traditional method of pouchoscopy with biopsies. By focusing on this specific patient population, the study seeks to enhance the understanding of disease activity and treatment response in ulcerative colitis patients post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with ulcerative colitis and have undergone ileal pouch-anal anastomosis.
Not a fit: Patients who may not benefit from this study include those with indeterminate colitis, those who have undergone IPAA for familial adenomatous polyposis, and individuals with a BMI over 30 kg/m2.
Why it matters
Potential benefit: If successful, this study could provide a safer and more accessible method for monitoring pouchitis in patients after IPAA.
How similar studies have performed: While intestinal ultrasound has been studied in inflammatory bowel disease, this specific application for ulcerative colitis patients with IPAA is relatively novel and has limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Darrell Pardi, MD — Mayo Clinic
- Study coordinator: Patricia Kammer, CCRP
- Email: kammer.patricia@mayo.edu
- Phone: (507)538-1827
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ulcerative Colitis, Pouchitis, Ileal Pouch Anal Anastomosis