Actively Recruiting
Non-invasive Assessment of RECTUM (POUCH) by US (RECT-US) in a Cohort of IBD Patients
Led by IRCCS San Raffaele · Updated on 2024-05-09
150
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Non-invasive Assessment of RECTUM (POUCH) by US (RECT-US) in a Cohort of IBD Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of inflammatory bowel disease for at least 3 months, including 50 with Crohn's disease, 50 with ulcerative colitis not undergoing proctocolectomy, and 50 with ulcerative colitis undergoing proctocolectomy with ileal pouch-anal anastomosis
- Undergoing ileocolonoscopy according to current standards of care and ECCO guidelines
- Assessed by both intestinal ultrasound and trans-perineal ultrasound as part of routine clinical practice
- Ability to understand and comply with study procedures
- Signed informed consent form
You will not qualify if you...
- Pregnant women
- Presence of intestinal infection such as Clostridium difficile
- Cirrhosis or intra-abdominal ascites
- Inability to comply with study procedures
- Inability to understand or provide informed consent
- Any contraindication to study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Irccs San Rafael Hospital
Milan, Italy, 20132
Actively Recruiting
Research Team
M
Mariangela Allocca, Medicine and Surgery
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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