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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standardized verbal counseling | Active Comparator | Participants receive standardized medical treatment plus standardized verbal counseling alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-assisted written patient information | Behavioral | Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain during defecation at 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. | Day 7 |
| Pain during defecation at Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vedat Kaplan | Contact | +905459045165 | vedat_kaplan_@hotmail.com |
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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.
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| ID | Term |
|---|---|
| D005401 | Fissure in Ano |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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Participants are randomized in a 1:1 ratio to either standardized verbal counseling or AI-assisted written patient information in a parallel-group design.
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| Standardized verbal counseling | Behavioral | Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment. |
|
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.
| Day 14 |
| Pain during defecation at 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. | Week 6 |
| Patient Global Impression of Change at 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. | Day 7 |
| Patient Global Impression of Change at 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. | Week 6 |
| D004066 |
| Digestive System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |