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