AI-Assisted Written Information in Chronic Anal Fissure
ConditionChronic Anal Fissure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSanliurfa Education and Research Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- AI-assisted written patient information
- Standardized verbal counseling
Treatment groups
220 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov