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A Study Comparing Transperineal Ultrasound, Magnetic Resonance Imaging, Endoscopic Ultrasound, and Examination Under Anesthesia to Detect and Classify Perianal Fistulas in Patients With Crohn's Disease or Fistulas of Unknown Cause

RecruitingNAAges 18 Years - 75 YearsAllAsian Institute of Gastroenterology, India
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to learn how well different imaging tests detect and describe perianal fistulas in adults with Crohn's disease or fistulas with no known cause (cryptogenic). Perianal fistulas are painful tunnels that form near the anus and can lead to discharge, swelling, or infection. The main questions this study aims to answer are: How accurate is transperineal ultrasound (TPUS) compared to magnetic resonance imaging (MRI) in finding fistulas? How well do these tests identify key features like internal openings and abscesses? Do the test results help doctors make better treatment decisions? Researchers will compare TPUS and MRI to two other imaging methods: Endoscopic ultrasound (EUS), which uses a small camera and ultrasound inside the rectum Examination under anesthesia (EUA), in which a surgeon checks the area while the participant is asleep All participants will: Be

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adults between 18 and 75 years of age * Clinical suspicion or diagnosis of perianal fistula * Fistula etiology can be Crohn's disease or cryptogenic/tubercular (non-Crohn's) * Ability to undergo all four imaging procedures (TPUS, MRI, EUS, and EUA) within a 10-day period * Willing and able to provide written informed consent Exclusion Criteria: * Known or suspected anorectal malignancy * Pregnancy or breastfeeding * Contraindications to any of the imaging procedures: * MRI (e.g., presence of metal implants or claustrophobia) * EUS (e.g., severe anal stenosis or intolerance to procedure) * Anesthesia required for EUA (e.g., significant cardiopulmonary disease) * Prior surgery or seton placement at the index fistula site * Incomplete or failed imaging in any one of the modalities * Inability to provide informed consent
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What it tests

  • Transperineal Ultrasound (TPUS)
  • Magnetic Resonance Imaging (MRI)
  • Endoscopic Ultrasound (EUS)
  • Examination Under Anesthesia (EUA)
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Where

1 site
Asian Institute of Gastroenterology
Hyderabad, India
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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