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

Ulcerative Colitis Clinical Trial

— RECT-US  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407674
• Other study ID #: RECT-US
• Status: Recruiting
• Start date: January 10, 2024
• Est. completion date: May 28, 2025

Study information

• Verified date: May 2024
• Source: IRCCS San Raffaele
• Contact: Mariangela Allocca, Medicine and Surgery
• Phone: +390226432069
• Email: allocca.mariangela[@]hsr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 28, 2025
• Est. primary completion date: November 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnancy;

• 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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Ulcerative Colitis

Locations

Country	Name	City	State
Italy	Irccs San Rafael Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation of data	To correlate ultrasound finding, both transabdominally and transperineally, with endoscopic findings	1 day (Cross Sectional study)