AI-Assisted Written Information in Chronic Anal Fissure

Effect of AI-Assisted Written Patient Information on Medical Treatment Adherence and Short-Term Patient-Reported Outcomes in Primary Chronic Anal Fissure: A Prospective Randomized Controlled 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.

This is a single-center, prospective, 1:1 randomized, parallel-group, superiority-type controlled trial. Adult patients with primary chronic anal fissure for whom initial medical/conservative treatment is planned will be enrolled. Participants will be randomized in a 1:1 ratio to two groups. The control group will receive standardized verbal counseling, whereas the intervention group will receive AI-assisted written patient information containing the same medical content and pre-validated by the investigators. The medical treatment regimen will be identical in both groups, and the only difference will be the method of patient information delivery. Assessments will be performed face-to-face at baseline, by telephone on days 7 and 14, and face-to-face at week 6. The primary endpoint is complete treatment adherence at day 14. Secondary outcomes include changes in pain and discomfort at days 7 and 14 and week 6, PGI-C, change in HEMO-FISS-QoL score, change in stool form, additional healthcare visits, need for interventional treatment, and patient satisfaction.

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