[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522122":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":28,"locations":33,"responsibleParty":96,"collaborators":99,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":124,"studyType":125,"phases":10,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Tampere University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Loop electrosurgical excision procedure (LEEP)",null,"Women directed to colposcopy examination due to cytological abnormality or repeated HPV-positivity and undergone a LEEP procedure due to HPV-related cervical lesion",[13],"Procedure: Loop electrosurgical excision procedure (LEEP)",{"label":15,"type":10,"description":16,"interventionNames":10},"Colposcopy only","Women directed to colposcopy examination due to cytological abnormality or repeated HPV-positivity with no indication to LEEP",[18],{"type":19,"name":9,"description":20,"armGroupLabels":21,"otherNames":22},"PROCEDURE","The affected area of cervix is excised under local anesthesia using a small thin electrically charged hardwire loop for simultaneous cutting and electrocoagulation.",[9],[23],"Large loop excision of the transformation zone (LLETZ)",[25],{"name":26,"affiliation":5,"role":27},"Laura Kotaniemi-Talonen, PhD","PRINCIPAL_INVESTIGATOR",[29],{"name":26,"role":30,"phone":31,"phoneExt":10,"email":32},"CONTACT","+358 3 311 66008","laura.kotaniemi-talonen@pirha.fi",[34,49,60,71,82],{"facility":35,"status":36,"city":37,"state":10,"zip":10,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Helsinki University Central Hospital","RECRUITING","Helsinki","Finland","FI",{"type":41,"coordinates":42},"Point",[43,44],24.93545,60.16952,{"lat":44,"lon":43},[47],{"name":48,"role":30,"phone":10,"phoneExt":10,"email":10},"Annu Heinonen, PhD",{"facility":50,"status":36,"city":51,"state":10,"zip":10,"country":38,"countryCode":39,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"North Karelia Central Hospital","Joensuu",{"type":41,"coordinates":53},[54,55],29.76316,62.60118,{"lat":55,"lon":54},[58],{"name":59,"role":30,"phone":10,"phoneExt":10,"email":10},"Ulla Korhonen, PhD",{"facility":61,"status":36,"city":62,"state":10,"zip":10,"country":38,"countryCode":39,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Kuopio University Hospital","Kuopio",{"type":41,"coordinates":64},[65,66],27.67703,62.89238,{"lat":66,"lon":65},[69],{"name":70,"role":30,"phone":10,"phoneExt":10,"email":10},"Johanna Palmroth, PhD",{"facility":72,"status":36,"city":73,"state":10,"zip":10,"country":38,"countryCode":39,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Oulu University Hospital","Oulu",{"type":41,"coordinates":75},[76,77],25.46816,65.01236,{"lat":77,"lon":76},[80],{"name":81,"role":30,"phone":10,"phoneExt":10,"email":10},"Marja Simojoki, PhD",{"facility":5,"status":36,"city":83,"state":10,"zip":10,"country":38,"countryCode":39,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Tampere",{"type":41,"coordinates":85},[86,87],23.78712,61.49911,{"lat":87,"lon":86},[90,93],{"name":91,"role":30,"phone":10,"phoneExt":10,"email":92},"Laura Kotaniemi-Talonen, Ass. prof","laura.kotaniemi-talonen@tuni.fi",{"name":94,"role":30,"phone":10,"phoneExt":10,"email":95},"Karolina Louvanto, Prof","karolina.louvanto@tuni.fi",{"type":27,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Laura Kotaniemi-Talonen","Deputy Chief, Gynecology and Obstetrics",[100,102,104,105,106,108,109],{"name":101,"class":6},"Tampere University",{"name":103,"class":6},"University of Helsinki",{"name":61,"class":6},{"name":72,"class":6},{"name":107,"class":6},"Hyvinkää Hospital",{"name":50,"class":6},{"name":35,"class":6},"100522122","sexual-function-and-quality-of-life-after-leep-a-prospective-multi-center-study-100522122",false,"NCT06078514","Sexual Function and Quality of Life After LEEP: a Prospective Multi-Center Study","SEQUEL","Inclusion Criteria:\n\n* Age 18 to 70 years\n* First colposcopy visit (in 24 months, if previous colposcopies)\n* Referral for cytological changes or repeated HPV positivity\n* No previous LEEP or other operations affecting the length of cervix\n* Not pregnant at the time of colposcopy\u002FLEEP\n* Sexually active\n* Capable of understanding the study protocol - informed consent given\n* Fluent in Finnish\n\nExclusion Criteria:\n\n* Age less than 18 or more than 70 years\n* Previous colposcopy within 24 months\n* Referral for other reason, e.g. vulvar lesion\n* Previous LEEP or other operation affecting the length of cervix\n* Pregnant at the time of colposcopy\u002FLEEP\n* Sexually inactive\n* Unable to understand the study protocol - no informed consent\n* Difficulties in understanding Finnish",true,"FEMALE","18 Years","70 Years",{"count":122,"type":123},1000,"ESTIMATED","5 Years","OBSERVATIONAL","The goal of this prospective study is to investigate the sexual function and quality of life of women undergoing loop electrosurgical excision procedure (LEEP) due to HPV-related cervical lesion.\n\nThe main question it aims to answer are:\n\n* Whether LEEP affects the sexual function of women in comparison to untreated women, and\n* Whether LEEP affects the health-related quality of life of women in comparison to untreated women\n\nParticipants are asked to complete web based an international validated self-report questionnaire on sexual function issues, the Female Sexual Function Index (FSFI), and a validated quality of life -questionnaire 15D at the time of first colposcopy appointment and six and 24 months, 3 years and 5 years after index visit (LEEP or first colposcopy in control group). Relevant additional background information is also collected via questionnaire and from patient files.\n\nResearchers will compare women with LEEP and those with only colposcopy visits to see any differences between self-reported sexual function (FSFI scores) or health-related quality of life (15D scores) both short and long-term.",[128],"Cervical Dysplasia",[130,131,132,133,134,135],"Colposcopy","LEEP","Cervical dysplasia","HSIL","Sexual function index","Health-related quality of life","2025-03-19",{"date":138,"type":139},"2025-03-20","ACTUAL",{"date":141,"type":139},"2024-05-02",{"date":143,"type":123},"2030-12",{"name":5,"class":6},5]