Non-invasive Assessment of RECTUM (POUCH) by US (RECT-US) in a Cohort of IBD Patients
NCT ID: NCT06407674
Last Updated: 2024-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2024-01-10
2025-05-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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ulcerative colitis
No interventions assigned to this group
crohn's disease
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Performing ileocolonoscopy, according to current standards of care and ECCO guidelines, will be assessed by both IUS and TPUS. Procedures performed routinely in clinical practice
* Ability to understand and comply with the study procedure and sign an informed consent form
Exclusion Criteria
* Concomitant intestinal infection (e.g. Clostridium difficile);
* Cirrhosis or intra-abdominal ascites.
* Subjects not able to comply with any study procedure;
* Subjects not able to understand and give informed consent form;
* Subjects with any contraindication to any study procedure.
18 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Mariangela Allocca
M.D, PhD
Locations
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Irccs San Rafael Hospital
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RECT-US
Identifier Type: -
Identifier Source: org_study_id
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