[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100351378":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":143,"collaborators":145,"id":154,"slug":155,"hasResults":156,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":32,"eligibilityCriteria":160,"healthyVolunteers":156,"sex":161,"minAge":162,"maxAge":163,"enrollmentInfo":164,"targetDuration":32,"studyType":167,"phases":168,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":51,"whyStopped":32,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"fullName":5,"class":6},"State Scientific Centre of Coloproctology, Russian Federation","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Xeomin","EXPERIMENTAL","Complex treatment of chronic anal fissure with drug-induced relaxation of the internal sphincter with Botulinum Toxin Type A. (IncobotulinumtoxinA 50 U Intramuscular Powder for Solution).",[13],"Drug: IncobotulinumtoxinA 50 U Intramuscular Powder for Solution",{"label":15,"type":16,"description":17,"interventionNames":18},"Xeomin control","ACTIVE_COMPARATOR","Complex treatment of chronic anal fissure with lateral subcutaneous sphincterotomy.",[19],"Procedure: Lateral subcutaneous sphincterotomy.",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","IncobotulinumtoxinA 50 U Intramuscular Powder for Solution","Sparing surgical removal of fissure without internal sphincter incision is held under spinal anesthesia in surgical room at lithotomy position using electrocoagulation.\n\nAfter that Botulinum Toxin Type A is injected into the internal anal sphincter at 1, 5, 7 and 11 o'clock (localization of injection points), 10 U at each point (40 U in total). Botulinum toxin type A (a 50 U vial) is diluted with 1.0 ml of 0.9% saline solution.",[9],[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Lateral subcutaneous sphincterotomy.","The patient is positioned on the table like for perineal lithotomy. After spinal anesthesia, the anal canal and then the surgical field are treated with 70% ethanol. Under the rectal speculum control, sparing surgical removal of fissure without internal sphincter incision is held using electrocoagulation.Then, in a 3 or 9 o'clock position, a narrow (eye) scalpel is inserted into the intersphincteric groove separating the external and internal sphincters, the scalpel blade is turned to the rectal lumen, and the internal sphincter is dissected up to the wall of the anal canal mucosa under the control of the finger inserted into the anal canal. After controlling hemostasis, the operation is ended with the introduction of the vent tube and hemostatic sponge.",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Sergey A. Frolov, Ph.D.","State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Evgeny E. Zharkov, MD","CONTACT","89039689739","drzharkov@mail.ru",{"name":45,"role":41,"phone":46,"phoneExt":32,"email":47},"Roman Yu. Khryukin, MD","+79161598059","texnik.lip@yandex.ru",[49,68,81,94,107,117,130],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"GBUZ MO \"Lvovskaia Raionaia Bolnica\"","RECRUITING","Podolsk","Moscow Oblast","142155","Russia","RU",{"type":58,"coordinates":59},"Point",[60,61],37.55472,55.42419,{"lat":61,"lon":60},[64],{"name":65,"role":41,"phone":66,"phoneExt":32,"email":67},"Vladimir Medvedev, MD","+79258977708","mr.vladimirmedvedev@mail.ru",{"facility":69,"status":51,"city":70,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Astrakhan State Medical University","Astrakhan",{"type":58,"coordinates":72},[73,74],48.04076,46.34968,{"lat":74,"lon":73},[77],{"name":78,"role":41,"phone":79,"phoneExt":79,"email":80},"Kostenko N Vladimirovich, MD","+79880784451","kostenki@mail.ru",{"facility":82,"status":51,"city":83,"state":32,"zip":84,"country":55,"countryCode":56,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Medical Center ON-CLINIC","Moscow","119034",{"type":58,"coordinates":86},[87,88],37.61781,55.75204,{"lat":88,"lon":87},[91],{"name":92,"role":41,"phone":93,"phoneExt":32,"email":32},"Evgeny A Zagryadsky, phd","+79104341786",{"facility":95,"status":51,"city":83,"state":32,"zip":96,"country":55,"countryCode":56,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"SSCCRussia","123423",{"type":58,"coordinates":98},[87,88],{"lat":88,"lon":87},[101,105],{"name":102,"role":41,"phone":103,"phoneExt":42,"email":104},"Sergey A Frolov, phd","+79039689739","DrZharkow@mail.ru",{"name":106,"role":41,"phone":42,"phoneExt":42,"email":43},"Evgeny E Zharkov",{"facility":108,"status":51,"city":83,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":109,"geoPoint":111,"contacts":112},"City Clinical Hospital №24, Department of Health City of Moscow",{"type":58,"coordinates":110},[87,88],{"lat":88,"lon":87},[113],{"name":114,"role":41,"phone":115,"phoneExt":115,"email":116},"Makoev S Nikolaevich, MD","+79037983363","makoev1972@mail.ru",{"facility":118,"status":51,"city":119,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"St. Petersburg State Pavlov Medical University","Saint Petersburg",{"type":58,"coordinates":121},[122,123],30.31413,59.93863,{"lat":123,"lon":122},[126],{"name":127,"role":41,"phone":128,"phoneExt":128,"email":129},"Demin A Nikolaevich, MD","89213374143","dan-7691@mail.ru",{"facility":131,"status":51,"city":132,"state":32,"zip":32,"country":55,"countryCode":56,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Siberian State Medical University","Tomsk",{"type":58,"coordinates":134},[135,136],84.98216,56.50049,{"lat":136,"lon":135},[139],{"name":140,"role":41,"phone":141,"phoneExt":141,"email":142},"Klinovitskiy I Yurjevich, MD","+79039131776","klinovitskiy@mail.ru",{"type":144,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[146,148,149,150,151,152],{"name":118,"class":147},"OTHER",{"name":69,"class":147},{"name":131,"class":147},{"name":108,"class":6},{"name":50,"class":6},{"name":82,"class":153},"UNKNOWN","100351378","phase-4-complex-treatment-of-a-chronic-anal-fissure-100351378",false,"NCT03855046","Complex Treatment of a Chronic Anal Fissure","A Comparative Efficacy and Safety Study of Lateral Subcutaneous Sphincterotomy and Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure","Inclusion Criteria:\n\n* Patients with chronic anal fissure\n\nExclusion Criteria:\n\n* Inflammatory diseases of the colon\n* Pectenosis\n* Previous surgical interventions on the anal canal\n* IV grade internal and external hemorrhoids\n* Rectal fistula\n* Severe somatic diseases at the decompensation stage\n* Pregnancy and lactation\n* Individual intolerance and hypersensitivity to botulinum toxin\n* Myasthenia gravis and myasthenia-like syndromes\n* Anal sphincter insufficiency","ALL","18 Years","70 Years",{"count":165,"type":166},340,"ESTIMATED","INTERVENTIONAL",[169],"PHASE4","This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.",[172],"Fissure in Ano",[174,175,176,177,178,179,180,181,182,183,184],"Internal sphincterotomy","Anal fissure","Chronic anal fissure","botulinum toxin A","proctologic diseases","surgical treatment","Chronic anal pain","Fecal incontinence","Spasm of the internal sphincter","Anal sphincter insufficiency","randomized","2022-01-26",{"date":187,"type":188},"2022-01-27","ACTUAL",{"date":190,"type":188},"2019-09-01",{"date":192,"type":166},"2022-11-01",{"name":5,"class":6},7]