Hemorrhoids Grade I and II, Symptomatic Hemorrhoidal Disease
Conditions
Keywords
Hemorrhoidal disease, Hemorrhoids, Treatment adherence, AI-assisted patient information, HEMO-FISS-QoL, PGI-C, Conservative treatment
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.
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.
Interventions
BEHAVIORALAI-assisted written patient information
Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.
BEHAVIORALStandardized verbal counseling
Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.
Sponsors
Sanliurfa Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Participants are randomized in a 1:1 ratio to either standardized verbal counseling or AI-assisted written patient information in a parallel-group design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HEMO-FISS-QoL total score from baseline to Day 28 | Baseline and Day 28 | Change in health-related quality of life measured by the HEMO-FISS-QoL total score from baseline to Day 28. |
| Patient Global Impression of Change at Day 28 | Day 28 | Patient Global Impression of Change assessed at Day 28. |
| Time to symptom improvement | Up to Day 28 | Time from baseline to the first patient-reported improvement in hemorrhoidal symptoms, measured in days. |
| Change in pain/discomfort score from baseline to Day 28 | Baseline and Day 28 | Change in pain or discomfort assessed using a Visual Analog Scale from baseline to Day 28. |
| Change in bleeding symptom severity from baseline to Day 28 | Baseline and Day 28 | Change in patient-reported bleeding symptoms from baseline to Day 28. |
| Change in swelling symptom severity from baseline to Day 28 | Baseline and Day 28 | Change in patient-reported swelling symptoms from baseline to Day 28. |
| Change in itching symptom severity from baseline to Day 28 | Baseline and Day 28 | Change in patient-reported itching symptoms from baseline to Day 28. |
| Change in soiling symptom severity from baseline to Day 28 | Baseline and Day 28 | Change in patient-reported soiling symptoms from baseline to Day 28. |
Countries
Turkey (Türkiye)
Contacts
CONTACTVedat Kaplan, MD
Outcome results
None listed