AI-Assisted Written Information in Chronic Anal Fissure

NCT07701811 · tracked via the Priya Life Science Turkey tracker

Sponsor

Sanliurfa Education and Research Hospital

Phase

Not applicable

Started

2026-07-15

Last updated

2026-09-09

Condition(s) studied

Chronic Anal Fissure

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, 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Complete treatment adherence at Day 14 — Day 14
Complete treatment adherence at Day 14, defined as a total adherence score of at least 5 out of 6 predefined treatment-behavior items: regular topical medication use, correct application to the target area, regular stool softener or fiber support, achievement of the water intake target, regular warm sitz bath or warm water application, and avoidance of excessive straining.

Trial sites (1)

Facility	City	Region	Status
Sanliurfa Education and Research Hospital	Sanliurfa	Turkey (Türkiye)	Recruiting

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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 NCT07701811 on ClinicalTrials.gov ↗ ← All trials in Turkey