Observational Recruiting
NCT06407674 on ClinicalTrials.gov
Non-invasive Assessment of RECTUM (POUCH) by US (RECT-US) in a Cohort of IBD Patients
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
- Sponsor: IRCCS Ospedale San Raffaele
- Enrollment: 150 (Estimated)
- Study start: 2024-01-10 (Actual)
- Primary completion: 2024-11-28 (Estimated)
- Study completion: 2025-05-28 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
Brief 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.
Conditions
- Ulcerative Colitis
- Crohn's Disease
Primary Outcome Measures
-
correlation of data
(1 day (Cross Sectional study))
To correlate ultrasound finding, both transabdominally and transperineally, with endoscopic findings
Countries
Italy
Locations and Investigators
- Irccs San Rafael Hospital, Milan, Italy (Recruiting)