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AI-Assisted Written Information in Chronic Anal Fissure

RecruitingNAAges 18 Years - anyAllSanliurfa Education and Research Hospital
NCT07701811 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This single-center, prospective, 1:1 randomized, parallel-group controlled superiority trial compares standard verbal counseling with AI-assisted written patient information in adults with primary chronic anal fissure receiving initial medical/conservative treatment. The primary objective is to determine whether AI-assisted written information improves complete treatment adherence at day 14. Secondary objectives include pain and discomfort outcomes, Patient Global Impression of Change, HEMO-FISS-QoL change, stool form change, additional healthcare visits, transition to interventional treatment, and patient satisfaction.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 18 years or older 2. Clinical diagnosis of primary chronic anal fissure 3. Initial medical/conservative treatment planned at first evaluation 4. Ability to read and understand Turkish 5. Reachable by telephone 6. Provision of written informed consent Exclusion Criteria: 1. Acute anal fissure 2. Suspicion or diagnosis of secondary fissure (including Crohn's disease, tuberculosis, HIV-related lesion, suspected malignancy, or atypical lateral fissure) 3. Planned botulinum toxin, surgery, or another interventional treatment 4. History of botulinum toxin or surgical treatment for anal fissure within the last 6 months 5. Concomitant perianal abscess, fistula, advanced hemorrhoidal disease, or another significant anorectal pathology 6. Pregnancy and early postpartum period
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What it tests

  • AI-assisted written patient information
  • Standardized verbal counseling
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Where

1 site
Sanliurfa Education and Research Hospital
Sanliurfa, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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