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

NCT06407674 | Recruiting

• 1 other identifier: RECT-US
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis; Crohn's Disease

Keywords

intestinal ultrasound; Ileocolonoscopy; Trans-perineal ultrasound

Outcome Measures

Primary Outcomes (1)

• correlation of data

  To correlate ultrasound finding, both transabdominally and transperineally, with endoscopic findings

  1 day (Cross Sectional study)

Study Arms (2)

ulcerative colitis

crohn's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 adult subjects (minimum age: 18 years) with IBD (established diagnosis since at least 3 months), specifically 50 with CD, 50 with UC not undergoing proctocolectomy, 50 with UC undergoing proctocolectomy with ileal pouch-anal anastomosis, irrespective of concomitant therapy, performing routine investigations with IC, according to the current standard of care indications and ECCO guidelines, will be assessed by both IUS and TPUS. Procedures performed routinely in clinical practice.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Irccs San Rafael Hospital

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Mariangela Allocca, Medicine and Surgery

CONTACT

+390226432069; allocca.mariangela@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, PhD

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: January 10, 2024
• Primary Completion: November 28, 2024
• Study Completion: May 28, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

IT (1)