AI-Assisted Written Information in Symptomatic Hemorrhoidal Disease (HD-AI)

Effect of AI-Assisted Written Patient Information on Medical Treatment Adherence and Short-Term Patient-Reported Outcomes in Symptomatic Hemorrhoidal Disease: A Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemorrhoids Grade I and II; Symptomatic Hemorrhoidal Disease
• Intervention / Treatment: Behavioral: AI-assisted written patient information; Behavioral: Standardized verbal counseling

Detailed Description

This is a single-center, prospective, parallel-group, 1:1 randomized controlled trial in adults with symptomatic hemorrhoidal disease for whom conservative/medical treatment is planned at the initial evaluation. After baseline assessment, participants will be randomized by sealed-envelope or computer-based block randomization into two groups. The control group will receive standardized verbal counseling. The intervention group will receive investigator-validated AI-assisted written patient information containing the same medical content. Standard medical treatment will be identical in both groups, and the only difference will be the method of information delivery. Participants will be assessed at baseline, day 7, day 14, and day 28. The primary endpoint is complete treatment adherence at day 14. Secondary outcomes include change in HEMO-FISS-QoL, PGI-C response, time to symptom improvement, change in pain/discomfort visual analog scale scores, change in bleeding, swelling, itching, and soiling symptoms, and unplanned repeat healthcare visits.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vedat Kaplan, MD; Phone Number: +905459045165; Email: vedat_kaplan_@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standardized verbal counseling; Participants receive standardized medical treatment plus standardized verbal counseling alone.	Behavioral: Standardized verbal counseling; Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.
Experimental: AI-assisted written patient information; 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; Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HEMO-FISS-QoL total score from baseline to Day 28	Change in health-related quality of life measured by the HEMO-FISS-QoL total score from baseline to Day 28.	Baseline and Day 28
Patient Global Impression of Change at Day 28	Patient Global Impression of Change assessed at Day 28.	Day 28
Time to symptom improvement	Time from baseline to the first patient-reported improvement in hemorrhoidal symptoms, measured in days.	Up to Day 28
Change in pain/discomfort score from baseline to Day 28	Change in pain or discomfort assessed using a Visual Analog Scale from baseline to Day 28.	Baseline and Day 28
Change in bleeding symptom severity from baseline to Day 28	Change in patient-reported bleeding symptoms from baseline to Day 28.	Baseline and Day 28
Change in swelling symptom severity from baseline to Day 28	Change in patient-reported swelling symptoms from baseline to Day 28.	Baseline and Day 28
Change in itching symptom severity from baseline to Day 28	Change in patient-reported itching symptoms from baseline to Day 28.	Baseline and Day 28
Change in soiling symptom severity from baseline to Day 28	Change in patient-reported soiling symptoms from baseline to Day 28.	Baseline and Day 28

Collaborators and Investigators

• Sponsor: Sanliurfa Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Hemorrhoidal disease; Conservative treatment; Hemorrhoids; Treatment adherence; AI-assisted patient information; HEMO-FISS-QoL; PGI-C
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Behavior; Health Behavior; Hemorrhoids; Treatment Adherence and Compliance
• Other Study ID Numbers: SEAH-HD-AI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because this is a single-center study involving sensitive patient-level clinical data, and there is no pre-specified institutional mechanism for external data sharing. Only aggregated, de-identified study results will be reported.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No