RecruitingNCT06407674

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

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 San Raffaele

Enrollment

150 participants

Start Date

Jan 10, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether intestinal ultrasound — a non-invasive imaging technique — can accurately assess inflammation and healing in the rectum and bowel pouch of people with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. **You may be eligible if...** - You have a confirmed diagnosis of Crohn's disease or ulcerative colitis for at least 3 months - You are scheduled to have a routine colonoscopy as part of your standard care - You are able to understand and agree to study procedures **You may NOT be eligible if...** - You are pregnant - You have other conditions that prevent you from undergoing the imaging or colonoscopy procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Irccs San Rafael Hospital

Milan, Italy

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NCT06407674


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