[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100350091":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":36,"responsibleParty":57,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":84,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Università degli Studi dell'Insubria","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transvaginal retrieval",null,"Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation",[13],"Procedure: Transvaginal tissue retrieval via a posterior colpotomy",{"label":15,"type":10,"description":16,"interventionNames":17},"Transabdominal retrieval","Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation",[18],"Procedure: Transabdominal retrieval via trocar",[20,24],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":10},"PROCEDURE","Transvaginal tissue retrieval via a posterior colpotomy",[9],{"type":21,"name":25,"description":16,"armGroupLabels":26,"otherNames":10},"Transabdominal retrieval via trocar",[15],[28],{"name":29,"affiliation":5,"role":30},"Antonio Simone Laganà, M.D.","PRINCIPAL_INVESTIGATOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":10,"email":35},"CONTACT","+393296279579","antoniosimone.lagana@asst-settelaghi.it",[37],{"facility":38,"status":10,"city":39,"state":10,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"\"Filippo Del Ponte\" Hospital","Varese","21100","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],8.82511,45.82058,{"lat":47,"lon":46},[50,51,53,55],{"name":29,"role":33,"phone":34,"phoneExt":10,"email":35},{"name":52,"role":30,"phone":10,"phoneExt":10,"email":10},"Fabio Ghezzi, Prof.",{"name":54,"role":30,"phone":10,"phoneExt":10,"email":10},"Jvan Casarin, Dr.",{"name":56,"role":30,"phone":10,"phoneExt":10,"email":10},"Simone Garzon, Dr.",{"type":30,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Antonio Simone Laganà","Principal Investigator","100350091","evaluation-of-sexual-functions-with-validated-measurement-scale-after-transvaginal-extraction-of-tissue-by-laparoscopic-surgery-with-uterus-preservation-fsf-tve-100350091",false,"NCT03838302","Evaluation of Sexual Functions With Validated Measurement Scale After Transvaginal Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation (FSF-TVE)","Evaluation of Female Sexual Functions With Validated Measurement Scale (Female Sexual Function Index) After Transvaginal Versus Trocars Extraction of Tissue by Laparoscopic Surgery With Uterus Preservation","FSF-TVE","Inclusion Criteria:\n\n* Benign uterine and adnexal pathology\n* Preservation of the uterus\n* Sexually active women\n* Premenopausal women\n\nExclusion Criteria:\n\n* Pelvic inflammatory disease, endometriosis and pre-existing dyspareunia or chronic pelvic pain of any origin\n* Previous Hysterectomy\n* Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases, psychopathology, mental and sensory-motor disabilities) comorbidities\n* Language barrier","FEMALE","18 Years","50 Years",{"count":72,"type":73},40,"ESTIMATED","OBSERVATIONAL","The retrieval of tissues removed by laparoscopic surgery larger than trocars caliber, with preservation of the uterus, required for a long time intraperitoneal electromechanical morcellation, until the Food and Drug Administration expressed concern about intraperitoneal dissemination of malignant cells, in the case of unrecognized sarcomas.\n\nTransvaginal contained tissue extraction via a posterior colpotomy and manual morcellation in the bag is one of the possible alternatives.\n\nAvailable data suggested the effectiveness and safety of this technique, also in terms of time and costs, without a increased risk intra and post-operative complications.\n\nThe available evidence shows the lack of sequelae also on fertility and sexual function.\n\nNevertheless, sexual function has never been evaluated qualitatively in all its aspects nor quantitatively with a validated measurement scale, which can allow us to inform the consequences on the real risk of implications on sexual function determined by vaginal incision. In view of these elements, the aim of the investigator's study is to compare patients in whom laparoscopic tissue removal has been carried out with posterior colpotomy or without it with removal from the trocars.",[77],"Transvaginal Tissue Extraction",[79,80,81,82,83],"Sexual functioning","Laparoscopy","Colpotomy","Specimen retrieval","Transvaginal extraction","NOT_YET_RECRUITING","2021-04-28",{"date":87,"type":88},"2021-04-29","ACTUAL",{"date":90,"type":73},"2023-06",{"date":92,"type":73},"2027-06",{"name":5,"class":6},1]