AI-Assisted Written Information in Chronic Anal Fissure
Starting soon · Not applicable
Conditions studied: Chronic Anal Fissure
In brief
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.
Key facts
- Study ID
- NCT07701811
- Run by
- Sanliurfa Education and Research Hospital
- People needed
- 220
- Starts
- 2026-07-15
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or older
- Clinical diagnosis of primary chronic anal fissure
- Initial medical/conservative treatment planned at first evaluation
- Ability to read and understand Turkish
- Reachable by telephone
- Provision of written informed consent
You may not qualify if…
- Acute anal fissure
- Suspicion or diagnosis of secondary fissure (including Crohn's disease, tuberculosis, HIV-related lesion, suspected malignancy, or atypical lateral fissure)
- Planned botulinum toxin, surgery, or another interventional treatment
- History of botulinum toxin or surgical treatment for anal fissure within the last 6 months
- Concomitant perianal abscess, fistula, advanced hemorrhoidal disease, or another significant anorectal pathology
- Pregnancy and early postpartum period
Full record on ClinicalTrials.gov
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