[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100421833":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":32,"centralContacts":37,"locations":48,"responsibleParty":69,"collaborators":53,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":53,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":53,"enrollmentInfo":81,"targetDuration":53,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":51,"whyStopped":53,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Ruhr University of Bochum","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"LLETZ group","LLETZ (large loop excision of the transformation zone) is one of several possible surgical interventions for treating cervical dysplasia.",[12],"Procedure: LLETZ",{"label":14,"type":6,"description":15,"interventionNames":16},"LEEP group","LEEP (loop electrosurgical excision procedure) is one of several possible surgical interventions for treating cervical dysplasia.",[17],"Procedure: LEEP",[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","LLETZ","LLETZ is one of several possible surgical interventions for treating cervical dysplasia. The transformation zone of the cervix is completely removed",[9],[25],"Large Loop Excision of the Transformation Zone",{"type":20,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"LEEP","LEEP is one of several possible surgical interventions for treating cervical dysplasia. Only the dysplastic lesion is removed without removing the whole transformation zone.",[14],[31],"Loop Electrosurgical Excision Procedure",[33],{"name":34,"affiliation":35,"role":36},"Clemens B Tempfer, MD, MBA","Ruhr-Universität Bochum \u002F Marien Hospital Herne","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Clemens B Temfper, MD, MBA","CONTACT","+492323499","1801","clemens.tempfer@rub.de",{"name":45,"role":40,"phone":41,"phoneExt":46,"email":47},"Günther A Rezniczek, PhD","1058","guenther.rezniczek@rub.de",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Dept. OBGYN Ruhr University Bochum","RECRUITING","Herne",null,"44625","Germany","DE",{"type":58,"coordinates":59},"Point",[60,61],7.22572,51.5388,{"lat":61,"lon":60},[64,68],{"name":65,"role":40,"phone":66,"phoneExt":42,"email":67},"Clemens Tempfer, MD","+49 2323 499","clemens.tempfer@marienhospital-herne.de",{"name":65,"role":36,"phone":53,"phoneExt":53,"email":53},{"type":36,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Clemens Tempfer","Principal Investigator","100421833","comparison-of-lletz-versus-leep-for-the-treatment-of-cervical-dysplasia-100421833",false,"NCT04772937","Comparison of LLETZ Versus LEEP for the Treatment of Cervical Dysplasia","Comparison of Two Surgical Approaches in the Treatment of Cervical Dysplasia: Complete Removal of the Transformation Zone (LLETZ) Versus Isolated Resection of the Colposcopically Visible Lesion (LEEP)","Inclusion Criteria:\n\n* Histologically confirmed High Grade Squamous Intraepithelial Lesion (HSIL)\n* Colposcopically visible lesion\n* No therapy of the disease so far\n\nExclusion Criteria:\n\n* Pregnancy of the patient at\u002Fafter inclusion in the study; pregnancy after conization and before the control after 6 months is possible and does not lead to exclusion from the study.\n* Taking immunosuppressive drugs (incl. glucocorticoids)\n* Known HIV positivity\n* Malignant disease requiring treatment\n* Unsatisfactory colposcopy","FEMALE","18 Years",{"count":82,"type":83},206,"ESTIMATED","INTERVENTIONAL",[86],"NA","Cervical dysplasia is the precursor of cervical cancer. LEEP and LLETZ are standard surgical procedures to treat cervical dysplasia. There is no direct head-to-head comparison between LEEP and LLETZ in the literature regarding oncologic safety, for which complete resection of the dysplastic lesion (so-called 'in-sano resection') is the most appropriate postoperative surrogate parameter. Further clinical studies are therefore useful to optimize surgical therapy for cervical dysplasia.\n\nThe primary objective of the present study is to compare LLETZ (resection of the dysplastic lesion including the transformation zone) with targeted resection of the colposcopically conspicuous lesion only (LEEP) and to compare it with regard to oncological safety (defined as non-in-sano rate).",[89],"Cervical Dysplasia",[91,92,93,94,21,27],"cervical dysplasia","conization","surgery","cervical cancer","2025-01-29",{"date":97,"type":98},"2025-01-30","ACTUAL",{"date":100,"type":98},"2021-06-07",{"date":102,"type":83},"2025-11",{"name":5,"class":6},1]