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RECRUITING
NCT06407674

Non-invasive Assessment of RECTUM (POUCH) by US (RECT-US) in a Cohort of IBD Patients

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

Summary

At enrollment, after informed consent form will be discussed and signed, subjects will undergo complete disease assessment. In this study, 150 adult subjects with IBD will be enrolled at the Gastroenterology Department of the San Raffaele Hospital (50 patients with Crohn's disease, 50 with Ulcerative colitis not undergoing proctocolectomy, and 50 with Ulcerative colitis undergoing proctocolectomy with ileal pouch-anal anastomosis). All the patients will perform routine investigations with Ileocolonoscopy (IC), according to the current standard of care indications and ECCO guidelines, and they will be assessed by both Intestinal Ultrasound (IUS) and Trans-perineal ultrasound (TPUS). Blood and stool samples will be obtained for fecal calprotectin (FC) and C-reactive protein (CRP) measurements, respectively, as normal clinical practice. All the procedures of this study are performed routinely in clinical practice. All the procedures are performed in a single day-visit for the patient.

Official title: Non-invasive Assessment of RECTUM (POUCH) by US (RECT-US): Multicentric, Observational and Cross-sectional Comparison Study With Colonoscopy in a Cohort of IBD Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2024-01-10

Completion Date

2025-05-28

Last Updated

2024-05-09

Healthy Volunteers

No

Locations (1)

Irccs San Rafael Hospital

Milan, Italy