[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632966":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":44,"centralContacts":45,"locations":51,"responsibleParty":66,"collaborators":44,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":44,"enrollmentInfo":80,"targetDuration":44,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":54,"whyStopped":44,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Çanakkale Onsekiz Mart University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Spasm-Controlled LIS","ACTIVE_COMPARATOR","Serial small open sphincterotomies performed under local anesthesia plus IV sedation. Anal caliber is measured with an anal calibrator before and after each increment until a caliber of 30 mm is achieved.",[13],"Procedure: Spasm-Controlled Lateral Internal Sphincterotomy",{"label":15,"type":10,"description":16,"interventionNames":17},"LIS up to Fissure Apex","Open lateral internal sphincterotomy extended to the proximal end of the fissure (fissure apex) under spinal or general anesthesia. The length of sphincterotomy equals the length of the fissure.",[18],"Procedure: Lateral Internal Sphincterotomy up to Fissure Apex",{"label":20,"type":10,"description":21,"interventionNames":22},"LIS up to Dentate Line","Open lateral internal sphincterotomy extended to the level of the dentate line under spinal or general anesthesia. This is the traditional (classical) LIS technique.",[23],"Procedure: Lateral Internal Sphincterotomy up to Dentate Line",[25,32,38],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Spasm-Controlled Lateral Internal Sphincterotomy","Serial small open sphincterotomies under local anesthesia plus IV sedation using an anal calibrator until anal caliber of 30 mm is achieved.",[9],[31],"Calibrated LIS",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Lateral Internal Sphincterotomy up to Fissure Apex","Open LIS extended to the proximal end of the fissure under spinal or general anesthesia.",[15],[37],"Tailored LIS",{"type":26,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Lateral Internal Sphincterotomy up to Dentate Line","Open LIS extended to the level of the dentate line under spinal or general anesthesia.",[20],[43],"Traditional LIS \u002F Classical LIS",null,[46],{"name":47,"role":48,"phone":49,"phoneExt":44,"email":50},"Emre Gülçek, MD, Assistant Professor","CONTACT","+905544810964","emre.gulcek@comu.edu.tr",[52],{"facility":53,"status":54,"city":55,"state":55,"zip":56,"country":57,"countryCode":44,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Canakkale Onsekiz Mart University","RECRUITING","Çanakkale","00017","Turkey (Türkiye)",{"type":59,"coordinates":60},"Point",[61,62],26.41271,40.15552,{"lat":62,"lon":61},[65],{"name":47,"role":48,"phone":49,"phoneExt":44,"email":50},{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"PRINCIPAL_INVESTIGATOR","Emre Gülçek","Assistant Professor of General Surgery","100632966","comparison-of-lateral-internal-sphincterotomy-techniques-for-chronic-anal-fissure-100632966",false,"NCT07520552","Comparison of Lateral Internal Sphincterotomy Techniques for Chronic Anal Fissure","A Prospective Randomized Controlled Trial Comparing Spasm-Controlled, Fissure Apex-Limited, and Dentate Line-Limited Lateral Internal Sphincterotomy Techniques in Chronic Anal Fissure","SPHINX","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of chronic anal fissure (duration ≥8 weeks)\n* Failure to heal after at least 6 weeks of appropriate medical treatment (topical agents, fiber supplementation, sitz baths)\n* Complete preoperative fecal continence (Wexner Incontinence Score = 0)\n* Primary anal fissure (posterior or anterior midline location)\n* Written informed consent\n\nExclusion Criteria:\n\n* Any degree of preoperative fecal incontinence\n* Secondary anal fissure (associated with Crohn's disease, tuberculosis, HIV, syphilis, or other systemic conditions)\n* Previous anal sphincter surgery\n* History of obstetric sphincter injury\n* Active anorectal infection (abscess or fistula)\n* Pregnancy or breastfeeding\n* Uncorrectable coagulopathy or current anticoagulant use\n* Inability to cooperate with study procedures or attend follow-up visits","ALL","18 Years",{"count":81,"type":82},150,"ESTIMATED","INTERVENTIONAL",[85],"NA","This prospective randomized controlled trial compares three lateral internal sphincterotomy (LIS) techniques in patients with chronic anal fissure refractory to medical treatment: (1) Spasm-Controlled LIS (serial small sphincterotomies using an anal calibrator until 30 mm anal caliber is achieved, under local anesthesia plus sedation), (2) LIS up to the Fissure Apex (spinal or general anesthesia), and (3) LIS up to the Dentate Line (spinal or general anesthesia). The primary outcomes are fissure healing rate and fecal incontinence incidence at 12 months, assessed using the Wexner Incontinence Score. Secondary outcomes include postoperative pain (VAS), recurrence rate, patient satisfaction, and complications. A total of 150 patients (50 per group) will be enrolled and followed for 12 months.",[88],"Chronic Anal Fissure",[90,91,92,93,94,95],"Chronic anal fissure","Lateral internal sphincterotomy","Spasm-controlled sphincterotomy","Fecal incontinence","Dentate line","Fissure apex","2026-05-12",{"date":98,"type":99},"2026-05-14","ACTUAL",{"date":101,"type":99},"2026-05-06",{"date":103,"type":82},"2028-05-06",{"name":5,"class":6},1]