Health TrialsbyHealthPanel

AI-Assisted Written Information in Chronic Anal Fissure

ConditionChronic Anal Fissure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSanliurfa Education and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Clinical diagnosis of primary chronic anal fissure

Initial medical/conservative treatment planned at first evaluation

Ability to read and understand Turkish

Disqualifiers

Acute anal fissure

Suspicion or diagnosis of secondary fissure (including Crohn's disease, tuberculosis, HIV-related lesion, suspected malignancy, or atypical lateral fissure)

Planned botulinum toxin, surgery, or another interventional treatment

History of botulinum toxin or surgical treatment for anal fissure within the last 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-assisted written patient information

    Behavioral

    Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.

  • Standardized verbal counseling

    Behavioral

    Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: AI-assisted written patient informationExperimental treatment 1 intervention
Group B: Standardized verbal counselingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 14

Secondary outcomes

1

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.

Time frame
Day 7
2

Pain during defecation at 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.

Time frame
Day 14
3

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.

Time frame
Week 6
4

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.

Time frame
Day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanliurfa Education and Research Hospital

Lead sponsor

Source ClinicalTrials.gov
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