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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06407674

Acronym

RECT-US

Enrollment

150

Registered

2024-05-09

Start date

2024-01-10

Completion date

2025-05-28

Last updated

2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Ulcerative Colitis

Keywords

intestinal ultrasound, Ileocolonoscopy, Trans-perineal ultrasound

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Italy

Contacts

Primary ContactMariangela Allocca, Medicine and Surgery

allocca.mariangela@hsr.it+390226432069

Outcome results