AI-Assisted Written Information in Symptomatic Hemorrhoidal Disease

NCT07701798 | Not Yet Recruiting

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

Brief 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.

Conditions

Symptomatic Hemorrhoidal Disease; Hemorrhoids Grade I and II

Keywords

Hemorrhoidal disease; Hemorrhoids; 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 full adherence to the prescribed medical treatment and lifestyle recommendations according to the study follow-up form.

  Day 14

Secondary Outcomes (8)

• Change in HEMO-FISS-QoL total score from baseline to Day 28

  Baseline and Day 28

• Patient Global Impression of Change at Day 28

  Day 28

• Time to symptom improvement

  Up to Day 28

• Change in pain/discomfort score from baseline to Day 28

  Baseline and Day 28

• Change in bleeding symptom severity from baseline to Day 28

  Baseline and Day 28

Study Arms (2)

AI-assisted written patient information

EXPERIMENTAL

Participants receive standardized medical treatment plus investigator-validated AI-assisted written patient information containing the same medical content as the verbal counseling.

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
• Diagnosis of symptomatic hemorrhoidal disease in the outpatient clinic
• Conservative/medical treatment planned at first evaluation
• Ability to read and understand Turkish
• Reachable by telephone
• Provision of written informed consent

You may not qualify if:

• Planned office procedure or surgery
• Emergency conditions such as thrombosed external hemorrhoid, strangulation, or massive bleeding
• Concomitant anal fissure, anal fistula, perianal abscess, inflammatory bowel disease, or suspicion of anal/colorectal malignancy
• History of hemorrhoidal intervention or surgery within the last 3 months
• Severe cognitive impairment, severe visual problem, or communication barrier
• Pregnancy and postpartum period
• Serious systemic conditions that would prevent completion of study follow-up

Sponsors & Collaborators

• Sanliurfa Education and Research Hospital: lead

MeSH Terms

Conditions

Hemorrhoids; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Health Behavior; Behavior

Central Study Contacts

Vedat Kaplan, MD

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