AI-Assisted Written Information in Chronic Anal Fissure

NCT07701811 | Not Yet Recruiting

• 1 other identifier: SEAH-AF-AI
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Anal Fissure

Keywords

Anal fissure; Chronic anal fissure; Treatment adherence; AI-assisted patient information; HEMO-FISS-QoL; PGI-C; Conservative treatment

Outcome Measures

Primary Outcomes (1)

• Complete treatment adherence at 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.

  Day 14

Secondary Outcomes (5)

• Pain during defecation at Day 7

  Day 7

• Pain during defecation at Day 14

  Day 14

• Pain during defecation at Week 6

  Week 6

• Patient Global Impression of Change at Day 7

  Day 7

• Patient Global Impression of Change at Week 6

  Week 6

Study Arms (2)

AI-assisted written patient information

EXPERIMENTAL

Participants receive standardized medical treatment plus AI-assisted written patient information that contains the same medical content as the verbal counseling and has been pre-validated by the investigators.

Behavioral: AI-assisted written patient information

Standardized verbal counseling

ACTIVE COMPARATOR

Participants receive standardized medical treatment plus standardized verbal counseling alone.

Behavioral: Standardized verbal counseling

Interventions

AI-assisted written patient information BEHAVIORAL

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

AI-assisted written patient information

Standardized verbal counseling BEHAVIORAL

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

Standardized verbal counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Clinical diagnosis of primary chronic anal fissure
• Initial medical/conservative treatment planned at first evaluation
• Ability to read and understand Turkish
• Reachable by telephone
• Provision of written informed consent

You may not qualify if:

• Acute anal fissure
• Suspicion or diagnosis of secondary fissure (including Crohn's disease, tuberculosis, HIV-related lesion, suspected malignancy, or atypical lateral fissure)
• Planned botulinum toxin, surgery, or another interventional treatment
• History of botulinum toxin or surgical treatment for anal fissure within the last 6 months
• Concomitant perianal abscess, fistula, advanced hemorrhoidal disease, or another significant anorectal pathology
• Pregnancy and early postpartum period

Sponsors & Collaborators

• Sanliurfa Education and Research Hospital: lead

MeSH Terms

Conditions

Fissure in Ano; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Health Behavior; Behavior

Central Study Contacts

Vedat Kaplan

CONTACT

+905459045165; vedat_kaplan_@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized in a 1:1 ratio to either standardized verbal counseling or AI-assisted written patient information in a parallel-group design.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share