[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492049":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":34,"locations":41,"responsibleParty":84,"collaborators":18,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":18,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":44,"whyStopped":18,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Universita di Verona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Total hysterectomy with a uterine manipulator","EXPERIMENTAL","Total hysterectomy with bilateral salpingo-oophorectomy performed with the use of a uterine manipulator during surgery.",[13],"Device: Uterine manipulator use",{"label":15,"type":16,"description":17,"interventionNames":18},"Total hysterectomy without a uterine manipulator","NO_INTERVENTION","Total hysterectomy with bilateral salpingo-oophorectomy performed without the use of a uterine manipulator during surgery.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Uterine manipulator use","The uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy.",[9],[26,30,32],{"name":27,"affiliation":28,"role":29},"Stefano Uccella, MD, PhD","AOUI Verona - University of Verona","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":28,"role":29},"Simone Garzon, MD",{"name":33,"affiliation":28,"role":29},"Pier Carlo Zorzato, MD",[35,39],{"name":27,"role":36,"phone":37,"phoneExt":18,"email":38},"CONTACT","0039 045 812 2720","stefano.uccella@univr.it",{"name":31,"role":36,"phone":37,"phoneExt":18,"email":40},"simone.garzon@univr.it",[42,60,73],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":46,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle","RECRUITING","Cuneo","Italy","12100","IT",{"type":50,"coordinates":51},"Point",[52,53],7.54828,44.39071,{"lat":53,"lon":52},[56],{"name":57,"role":36,"phone":58,"phoneExt":18,"email":59},"Andrea Puppo, Dr.","00000000000","puppo.a@ospedale.cuneo.it",{"facility":61,"status":44,"city":62,"state":18,"zip":18,"country":46,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"UOC Ostetricia e Ginecologia, Arcispedale Santa Maria Nuova","Reggio Emilia",{"type":50,"coordinates":64},[65,66],10.63125,44.69825,{"lat":66,"lon":65},[69],{"name":70,"role":36,"phone":71,"phoneExt":18,"email":72},"Vincenzo Dario Mandato, Dr.","000000000","VincenzoDario.Mandato@ausl.re.it",{"facility":74,"status":44,"city":75,"state":18,"zip":76,"country":46,"countryCode":48,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"AOUI Verona - University of Verona - Department of Obstetrics and Gynecology","Verona","37125",{"type":50,"coordinates":78},[79,80],10.9938,45.43854,{"lat":80,"lon":79},[83],{"name":31,"role":36,"phone":18,"phoneExt":18,"email":18},{"type":29,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Stefano Uccella","Prof. Stefano Uccella","100492049","uterine-manipulator-versus-no-uterine-manipulator-in-endometrial-cancer-trial-100492049",false,"NCT05687084","Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer Trial","Randomized Controlled Trial on the Oncologic Outcomes of Use Versus Not Use of the Uterine Manipulator in the Surgical Treatment of Apparent Uterine-confined Endometrial Carcinoma","MANEC","Inclusion Criteria:\n\n* Diagnosis of Endometrial Cancer of any histology (including carcinosarcoma) and grade\n* Planned surgical treatment including hysterectomy and bilateral salpingo-oophorectomy (ovarian preservation in selected patients is not an exclusion criterion)\n* Age ≥ 18 years\n* No preoperative evidence of extrauterine disease (Clinical stage IIIA, IIIB)\n* No preoperative evidence of suspicious lymph nodes (Clinical stage IIIC)\n* No preoperative evidence of distant metastasis (Clinical stage IV)\n* Approved and signed informed consent\n\nExclusion Criteria:\n\n* Neoadjuvant therapy\n* Synchronous or previous (\\\u003C 5 years) invasive cancer, not including non-melanoma skin cancer\n* Fertility preservation\n* World Health Organization performance score \\> 2\n* Uterine sarcoma\n* Previous pelvic\u002Fabdominal radiotherapy, hormone therapy for cancer (\\\u003C 5 years), chemotherapy (\\\u003C 5 years), pelvic or paraaortic lymphadenectomy, or retroperitoneal surgery\n* Inadequate bone marrow function (white blood cells \\\u003C3·0×109\u002FL, platelets \\\u003C100×109\u002FL)\n* Inadequate liver function (bilirubin \\>1.5×upper normal limit \\[UNL\\], aspartate aminotransferase, and alanine aminotransferase \\>2.5 × UNL)\n* Inadequate kidney function (creatinine clearance \\\u003C 60 mL per min calculated according to Cockcroft-Gault 10 or \\\u003C 50 mL per min Ethylenediaminetetraacetic acid clearance)\n* Intraoperative evidence of stage IV disease","FEMALE","18 Years","100 Years",{"count":99,"type":100},1030,"ESTIMATED","INTERVENTIONAL",[103],"NA","Minimally invasive surgery is the recommended approach in endometrial cancer (EC) patients based on the results of two randomized controlled trials, given its advantages without compromised oncologic outcomes. The uterine manipulator is commonly used in benign and malignant pathologies to perform a laparoscopic or robotic hysterectomy. However, although regularly used, the uterine manipulator adoption in EC is a controversial technical aspect due to the raised concerns regarding the possible risk of disruption of the tumor mass, the spread of malignant cells, and seeding of the disease, particularly at the level of the vaginal cuff or spread of tumor cells, with increased risk of recurrence and death due to EC. On that basis, given that hysterectomy without a uterine manipulator is feasible, only a randomized controlled trial comparing oncologic outcomes in EC patients after use versus not use of the uterine manipulator will be able to provide high-quality evidence to answer this critical question and allow or exclude the use of a uterine manipulator during minimally invasive hysterectomy for EC.",[106],"Endometrial Neoplasms",[106,108,109,110,111,112,113],"Uterine manipulator","Laparoscopic hysterectomy","Recurrence-free survival","Cause-specific survival","Overall survival","Oncologic outcomes","2026-04-28",{"date":116,"type":117},"2026-05-05","ACTUAL",{"date":119,"type":117},"2023-01-16",{"date":121,"type":100},"2031-12-31",{"name":5,"class":6},3]