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AI-Assisted Written Information in Symptomatic Hemorrhoidal Disease

RecruitingNAAges 18 Years - anyAllSanliurfa Education and Research Hospital
NCT07701798 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • AI-assisted written patient information
  • Standardized verbal counseling
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Where

1 site
Sanliurfa Education and Research Hospital
Sanliurfa, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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