[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645585":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":25,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":25,"enrollmentInfo":48,"targetDuration":25,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":65,"whyStopped":25,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":25},{"fullName":5,"class":6},"Sanliurfa Education and Research Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: AI-assisted written patient information",{"label":15,"type":16,"description":17,"interventionNames":18},"Standardized verbal counseling","ACTIVE_COMPARATOR","Participants receive standardized medical treatment plus standardized verbal counseling alone.",[19],"Behavioral: Standardized verbal counseling",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Vedat Kaplan","CONTACT","+905459045165","vedat_kaplan_@hotmail.com",{"type":36,"investigatorFullName":31,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100645585","ai-assisted-written-information-in-chronic-anal-fissure-100645585",false,"NCT07701811","AI-Assisted Written Information in Chronic Anal Fissure","Effect of AI-Assisted Written Patient Information on Medical Treatment Adherence and Short-Term Patient-Reported Outcomes in Primary Chronic Anal Fissure: A Prospective Randomized Controlled Trial","AF-AI","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Clinical diagnosis of primary chronic anal fissure\n3. Initial medical\u002Fconservative treatment planned at first evaluation\n4. Ability to read and understand Turkish\n5. Reachable by telephone\n6. Provision of written informed consent\n\nExclusion Criteria:\n\n1. Acute anal fissure\n2. Suspicion or diagnosis of secondary fissure (including Crohn's disease, tuberculosis, HIV-related lesion, suspected malignancy, or atypical lateral fissure)\n3. Planned botulinum toxin, surgery, or another interventional treatment\n4. History of botulinum toxin or surgical treatment for anal fissure within the last 6 months\n5. Concomitant perianal abscess, fistula, advanced hemorrhoidal disease, or another significant anorectal pathology\n6. Pregnancy and early postpartum period","ALL","18 Years",{"count":49,"type":50},220,"ESTIMATED","INTERVENTIONAL",[53],"NA","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\u002Fconservative 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.",[56],"Chronic Anal Fissure",[58,59,60,61,62,63,64],"Anal fissure","Chronic anal fissure","Treatment adherence","AI-assisted patient information","HEMO-FISS-QoL","PGI-C","Conservative treatment","NOT_YET_RECRUITING","2026-07-08",{"date":68,"type":69},"2026-07-14","ACTUAL",{"date":71,"type":50},"2026-07-15",{"date":73,"type":50},"2026-12-31",{"name":5,"class":6}]