AI-Assisted Written Information in Symptomatic Hemorrhoidal Disease

Effect of AI-Assisted Written Patient Information on Medical Treatment Adherence and Short-Term Patient-Reported Outcomes in Symptomatic Hemorrhoidal Disease: A Prospective Randomized Controlled Trial

This single-center, prospective, parallel-group, 1:1 randomized controlled trial compares standardized verbal counseling with AI-assisted written patient information in adults with symptomatic hemorrhoidal disease receiving initial conservative/medical treatment. The primary objective is to determine whether AI-assisted written information improves complete treatment adherence at day 14. Secondary objectives include quality-of-life change, Patient Global Impression of Change, time to symptom improvement, change in pain/discomfort scores, change in bleeding, swelling, itching, and soiling symptoms, and unplanned repeat healthcare visits.

This is a single-center, prospective, parallel-group, 1:1 randomized controlled trial in adults with symptomatic hemorrhoidal disease for whom conservative/medical treatment is planned at the initial evaluation. After baseline assessment, participants will be randomized by sealed-envelope or computer-based block randomization into two groups. The control group will receive standardized verbal counseling. The intervention group will receive investigator-validated AI-assisted written patient information containing the same medical content. Standard medical treatment will be identical in both groups, and the only difference will be the method of information delivery. Participants will be assessed at baseline, day 7, day 14, and day 28. The primary endpoint is complete treatment adherence at day 14. Secondary outcomes include change in HEMO-FISS-QoL, PGI-C response, time to symptom improvement, change in pain/discomfort visual analog scale scores, change in bleeding, swelling, itching, and soiling symptoms, and unplanned repeat healthcare visits.

Inclusion Criteria:

1. Age 18 years or older
2. Diagnosis of symptomatic hemorrhoidal disease in the outpatient clinic
3. Conservative/medical 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. Planned office procedure or surgery
2. Emergency conditions such as thrombosed external hemorrhoid, strangulation, or massive bleeding
3. Concomitant anal fissure, anal fistula, perianal abscess, inflammatory bowel disease, or suspicion of anal/colorectal malignancy
4. History of hemorrhoidal intervention or surgery within the last 3 months
5. Severe cognitive impairment, severe visual problem, or communication barrier
6. Pregnancy and postpartum period
7. Serious systemic conditions that would prevent completion of study follow-up