Non-invasive assessment of the rectum in patients with inflammatory bowel disease
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
This study is testing non-invasive ways to check the rectum in adults with inflammatory bowel disease to see how well these methods work for people with Crohn's disease and ulcerative colitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06407674 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the rectum in patients with inflammatory bowel disease (IBD) using non-invasive methods such as intestinal ultrasound and trans-perineal ultrasound. A total of 150 adult subjects will be enrolled, including those with Crohn's disease and ulcerative colitis, both with and without prior surgical procedures. Participants will undergo routine assessments including ileocolonoscopy, and blood and stool samples will be collected for further analysis. All procedures will be conducted in a single visit at the Gastroenterology Department of San Raffaele Hospital.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with inflammatory bowel disease, specifically Crohn's disease or ulcerative colitis, who meet the inclusion criteria.
Not a fit: Patients who are pregnant, have concomitant intestinal infections, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the non-invasive monitoring of rectal health in IBD patients, potentially leading to better management of their condition.
How similar studies have performed: Previous studies utilizing non-invasive imaging techniques in IBD patients have shown promising results, indicating that this approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan
- Irccs San Rafael Hospital — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Mariangela Allocca, Medicine and Surgery
- Email: allocca.mariangela@hsr.it
- Phone: +390226432069
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.