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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Confirmed diagnosis of IBD for at least 3 months, in particular 50 with Crohn\&;s disease (CD), 50 with ulcerative colitis (UC) not undergoing proctocolectomy, 50 with ulcerative colitis (UC) undergoing proctocolectomy with ileal pouch-anal anastomosis

• 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

Locations
Other Locations
Italy
Irccs San Rafael Hospital
RECRUITING
Milan
Contact Information
Primary
Mariangela Allocca, Medicine and Surgery
allocca.mariangela@hsr.it
+390226432069
Time Frame
Start Date: 2024-01-10
Estimated Completion Date: 2025-05-28
Participants
Target number of participants: 150
Treatments
ulcerative colitis
crohn's disease
Sponsors
Leads: IRCCS San Raffaele

This content was sourced from clinicaltrials.gov