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RECRUITING Not applicable ClinicalTrials.gov

AI-Assisted Written Information in Symptomatic Hemorrhoidal Disease

Sponsor: Sanliurfa Education and Research Hospital • ClinicalTrials.gov ID: NCT07701798

Registry updated: 2026-09-02
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Description

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.

Interventions

  • AI-assisted written patient information (Behavioral)
    Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.
  • Standardized verbal counseling (Behavioral)
    Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.

Eligibility criteria

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

Conditions

Symptomatic Hemorrhoidal Disease Hemorrhoids Grade I and II

Locations

  • Sanliurfa Education and Research Hospital — Sanliurfa, Şanlıurfa, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record