Chronic Anal Fissure
Conditions
Keywords
Anal fissure, Chronic anal fissure, Treatment adherence, AI-assisted patient information, HEMO-FISS-QoL, PGI-C, Conservative treatment
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.
Detailed description
This is a single-center, prospective, 1:1 randomized, parallel-group, superiority-type controlled trial. Adult patients with primary chronic anal fissure for whom initial medical/conservative treatment is planned will be enrolled. Participants will be randomized in a 1:1 ratio to two groups. The control group will receive standardized verbal counseling, whereas the intervention group will receive AI-assisted written patient information containing the same medical content and pre-validated by the investigators. The medical treatment regimen will be identical in both groups, and the only difference will be the method of patient information delivery. Assessments will be performed face-to-face at baseline, by telephone on days 7 and 14, and face-to-face at week 6. The primary endpoint is complete treatment adherence at day 14. Secondary outcomes include changes in pain and discomfort at days 7 and 14 and week 6, PGI-C, change in HEMO-FISS-QoL score, change in stool form, additional healthcare visits, need for interventional treatment, and patient satisfaction.
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. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain during defecation at Day 7 | Day 7 | Pain during defecation assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain. |
| Pain during defecation at Day 14 | Day 14 | Pain during defecation assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain. |
| Pain during defecation at Week 6 | Week 6 | Pain during defecation assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain. |
| Patient Global Impression of Change at Day 7 | Day 7 | Patient Global Impression of Change assessed on a 7-category ordinal scale: very much improved, much improved, a little improved, unchanged, a little worse, much worse, and very much worse. |
| Patient Global Impression of Change at Week 6 | Week 6 | Patient Global Impression of Change assessed on a 7-category ordinal scale: very much improved, much improved, a little improved, unchanged, a little worse, much worse, and very much worse. |
Countries
Turkey (Türkiye)
Contacts
CONTACTVedat Kaplan
Outcome results
None listed