[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497748":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":45,"locations":53,"responsibleParty":69,"collaborators":28,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":28,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":28,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":28,"overallStatus":56,"whyStopped":28,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional Abdominal Laparoscopy","ACTIVE_COMPARATOR","Use of conventional transabdominal laparoscopy as the surgical approach to perform the indicated procedure in the included patient with benign adnexal pathology (elective cystectomy\u002Foophorectomy elective salpingectomy or tubal sterilization).",[13,14,15,16],"Procedure: Elective cystectomy","Procedure: Elective oophorectomy","Procedure: Elective salpingectomy","Procedure: Elective tubal sterilization",{"label":18,"type":19,"description":20,"interventionNames":21},"vNOTES","EXPERIMENTAL","Use of vNOTES (Transvaginal Natural Orifice Transluminal Endoscopic Surgery) as the surgical approach to perform the indicated procedure in the included patient with benign adnexal pathology (elective cystectomy\u002Foophorectomy elective salpingectomy or tubal sterilization).",[13,14,15,16],[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Elective cystectomy","Adnexal cyst removal for presumed benign adnexal pathology.",[9,18],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Elective oophorectomy","Ovarian removal for presumed benign adnexal pathology.",[9,18],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Elective salpingectomy","Tubal removal for presumed benign adnexal pathology.",[9,18],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Elective tubal sterilization","Tubal obstruction as a definitive contraceptive method (tubal cauterization with or without sectioning, partial or total removal of both tubes, or obstruction with small clips\u002Fligatures).",[9,18],[42],{"name":43,"affiliation":5,"role":44},"Jean Dubuisson","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":50},"Eloïse Krull","CONTACT","+41 (0)22 372 68 16","eloise.krull@bluewin.ch",{"name":43,"role":48,"phone":28,"phoneExt":28,"email":52},"Jean.Dubuisson@hcuge.ch",[54],{"facility":55,"status":56,"city":57,"state":28,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Geneva University Hospital","RECRUITING","Geneva","1205","Switzerland","CH",{"type":62,"coordinates":63},"Point",[64,65],6.14569,46.20222,{"lat":65,"lon":64},[68],{"name":43,"role":48,"phone":28,"phoneExt":28,"email":28},{"type":70,"investigatorFullName":43,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Principal Investigator","100497748","assessment-of-womens-sexual-quality-of-life-after-benign-adnexal-surgery-using-vnotes-approach-100497748",false,"NCT05761275","Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach","Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach in Comparison to Conventional Laparoscopy: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Women aged from 18 to 70 years\n* Discernment capacity with oral and written consent signed\n* Heterosexual intercourse (with vaginal penetration) within four weeks prior to inclusion in the study\n\nExclusion Criteria:\n\n* History of rectal surgery.\n* Suspected rectovaginal\u002Fretrocervical endometriosis.\n* History of brachytherapy or pelvic radiation.\n* Suspected malignancy.\n* History of severe pelvic inflammatory disease.\n* Active lower genital tract infection.\n* Pregnancy.\n* Women who do not speak fluent French or English.\n* Patients under tutelage (with or without capacity of judgement).","FEMALE","18 Years","70 Years",{"count":83,"type":84},62,"ESTIMATED","INTERVENTIONAL",[87],"NA","Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is a recent innovation in minimally invasive surgery which has already proven its non-inferiority to conventional abdominal laparoscopy (CAL) for hysterectomy in terms of efficiency and safety. However, the investigators note a lack of medical literature and no specific randomized controlled trial (RCT) assessing women's sexual function after vNOTES for benign adnexal surgery.\n\nThe aim of this RCT is to confirm the non-inferiority of the vNOTES approach for benign adnexal pathology compared to CAL on women's sexual function. Secondary outcomes will evaluate vNOTES's efficiency, morbidity and postoperative complications compared to CAL for benign adnexal surgery. The relationship between adnexal mass morcellation\u002Faspiration and the quality of the histological analysis on surgical specimens will also be evaluated as secondary outcome.",[90,91,92,93,94,95,96,97,98,99,100],"Gynecologic Disease","Adnexal Mass","Adnexal Cyst","Sexuality","Adnexal Diseases","Sexual Dysfunction","Quality of Life","Pathology","Dyspareunia","Pelvic Pain","Complication","2025-03-24",{"date":103,"type":104},"2025-03-27","ACTUAL",{"date":106,"type":104},"2024-01-01",{"date":108,"type":84},"2027-04-03",{"name":43,"class":6},1]