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RECRUITING Not applicable ClinicalTrials.gov

AI-Assisted Written Information in Chronic Anal Fissure

Sponsor: Sanliurfa Education and Research Hospital • ClinicalTrials.gov ID: NCT07701811

Registry updated: 2026-09-09
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Description

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.

Interventions

  • AI-assisted written patient information (Behavioral)
    Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.
  • Standardized verbal counseling (Behavioral)
    Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.

Eligibility criteria

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

Conditions

Chronic Anal Fissure

Locations

  • Sanliurfa Education and Research Hospital — Sanliurfa, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record