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NCT05721794
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
Conditions: Crohn Disease, Perianal Fistula
Sex: All
Ages: 18 Years – N/A
Enrollment: 50
Sponsor: IRCCS San Raffaele
Location: Italy
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
Eligibility Criteria
Inclusion Criteria:Patients >18 yearsConfirmed 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 formExclusion Criteria:Controindications to MRISevere comorbidities that limit the performance of MRI and TPUSPregnancy
Source: ClinicalTrials.gov (NCT05721794). StuddyBuddy aggregates publicly available trial information.