Comparative Accuracy of Transperineal Ultrasound (TPUS) Versus Magnetic Resonance Imaging (MRI) for the Assessment of Perianal Fistulae in Patients With Crohn's Disease (CD): a Prospective Observational Longitudinal Cohort Study

NCT05721794 | Unknown

• 1 other identifier: TPUS-MRI
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Crohn's disease (CD) is a life-long chronic inflammatory bowel disease (IBD) that may affect any site of the gastrointestinal tract, most frequently the ileum and colon. It is characterized by transmural inflammation and it can lead to strictures, due to activation of reparation of inflamed tissues and consequent fibrosis, or penetrating lesions, such as fistulas, between two different intestinal tracts or between intestine and surrounding organs. Fistula occurrence can lead to formation of abdominal or pelvic abscesses. Such complications cause intestinal damage and usually require surgery, leading to disability, impairment of patients' quality of life, with significant impact on direct and indirect health-care costs

Conditions

Crohn Disease; Perianal Fistula

Outcome Measures

Primary Outcomes (1)

• Incidence rate of perianal fistulae through the MAGNIFI-CD index (by TPUS) and the standard MAGNIFI-CD index (by MRI)

  To compare the accuracy of the TPUS versus pelvic MRI in assessing perianal fistulae in CD patients. Accuracy is defined as the ability to identify perianal fistulae

  1 year

Secondary Outcomes (1)

• Rate of fistula closure, determined by the clinician, at 12 months.

  1 year

Interventions

A multicentric prospective observational longitudinal cohort study. OTHER

Observational study on the accuracy of TPUS and MRI in the investigation of perianal fistulae in CD patients.

Eligibility Criteria

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

Study Population

50 adult patients with confirmed diagnosis of Crohn's disease and suspicion of perianal fistulae will be enrolled in the study. Number and length of fistulae will be evaluated through MRI and TPUS. In addition, the response to treatment, defined as rate of fistula closure will also be evaluated with both techniques

You may qualify if:

• Patients \>18 years
• Confirmed diagnosis of Crohn's disease.
• Clinical suspicion of perianal fistulae (e.g., perianal pain or swelling, drainage of pus, stool or stool from cutaneous fistula opening, and signs and symptoms of sepsis)
• Able to understand and sign an informed consent form

You may not qualify if:

• Controindications to MRI
• Severe comorbidities that limit the performance of MRI and TPUS
• Pregnancy

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Mariangela Allocca

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Mariangela Allocca

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARIANGELA ALLOCCA

CONTACT

0226432069; allocca.mariangela@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: gastroenterologist physician

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 10, 2023
• Study Start: July 18, 2022
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2024
• Last Updated: February 10, 2023

Record last verified: 2023-01

Locations

IT (1)