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Recruiting NCT07701811

AI-Assisted Written Information in Chronic Anal Fissure

Conditions: Chronic Anal Fissure

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 220
Sponsor: Sanliurfa Education and Research Hospital

Location: Sanliurfa Education and Research Hospital Sanliurfa

Summary

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.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07701811). StuddyBuddy aggregates publicly available trial information.