Ireland
--:--IST
Recruiting Not applicable

AI-Assisted Written Information in Symptomatic Hemorrhoidal Disease

NCT07701798 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-07-15
Last updated
2026-09-02

Condition(s) studied

Symptomatic Hemorrhoidal DiseaseHemorrhoids Grade I and II

Investigational drug(s) / intervention(s)

AI-assisted written patient informationStandardized verbal counseling

AI-assisted written patient information: Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.

Standardized verbal counseling: Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Complete treatment adherence at Day 14 — Day 14
    Complete treatment adherence at Day 14, defined as full adherence to the prescribed medical treatment and lifestyle recommendations according to the study follow-up form.

Trial sites (1)

FacilityCityRegionStatus
Sanliurfa Education and Research Hospital Sanliurfa Şanlıurfa Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07701798 on ClinicalTrials.gov ↗ ← All trials in Turkey