[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577738":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":26,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"patients undergoing total hysterectomy","ACTIVE_COMPARATOR","Total hysterectomy involves the complete removal of the uterus including the cervix",[13],"Procedure: total hysterectomy",{"label":15,"type":16,"description":17,"interventionNames":18},"patients undergoing subtotal hysterectomy","EXPERIMENTAL","Subtotal hysterectomy involves the removal of the upper part of the uterus preserving the cervix",[19],"Procedure: subtotal hysterectomy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","total hysterectomy","Total hysterectomy (TH) involves the complete removal of the uterus including the cervix",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"subtotal hysterectomy","subtotal hysterectomy (STH) preserves the cervix while removing the upper part of the uterus",[15],[32],{"name":33,"affiliation":5,"role":34},"Giovanni Panico, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+390630153567","giovanni.panico@policlinicogemelli.it",[41],{"facility":42,"status":26,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ginecologia Oncologica","Rome","Lazio","00168","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],12.51133,41.89193,{"lat":52,"lon":51},[55,56,57],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"name":58,"role":59,"phone":26,"phoneExt":26,"email":26},"Giovanni Scambia, Prof","SUB_INVESTIGATOR",{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100577738","a-randomized-study-comparing-subtotal-vs-total-hysterectomy-long-term-outcomes-100577738",false,"NCT06802198","A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes","Comparison of Long-Term Outcomes Following Laparoscopic Total Vs Supracervical Hysterectomy, a Randomized Clinical Trial","STORY","Inclusion Criteria:\n\n* Age\\>18 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* Uterine or adnexal pathology suspect for malignancy\n* Abnormal or unknown PAP test\n* Patients with invasive neoplasia in the previous 5 years (excluding non-melanoma skin tumors, breast cancer T1 N0 M0 Grade 1 or 2 without signs of recurrence or activity).\n* Previous radical pelvic surgery or radiotherapy;\n* Age \\> 80 years\n* Pregnant patients\n* Desire for further pregnancies\n* Contraindications to general anaesthesia or to the Trendelenburg position\n* Refusal to sign informed consent","FEMALE","18 Years","80 Years",{"count":74,"type":75},500,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this randomized clinical trial is to assess the outcomes of total laparoscopic hysterectomy vs subtotal laparoscopic hysterectomy + mini-laparotomy for uterine extraction for benign gynecological conditions in terms of change in quality of life at 36 months after surgery and patient's impression of improvement. The secondary objectives of the study are to assess any differences in terms of peri and postoperative outcomes (postoperative pain, blood loss, hospital stay, intraoperative or short and long-term postoperative complications, long term urinary, bowel and pelvic floor symptoms, prevalence of vaginal cuff dehiscence).\n\nParticipants will fill the following questionnaires pre-operatively and at the follow up:\n\n* Short Form 36 (SF36),\n* Euro Quality of life 5D-3L (EQ 5D-3L)\n* Female Sexual Function Index (FSFI)\n* Patient Global Impression of Improvement (PGI-I) only during the follow-up period.",[81,82,83,84,85,86],"Fibroid Uterus","Metrorrhagia","Adenomyosis","Benign Gynecologic Neoplasm","Endometriosis","Abnormal Uterine Bleeding","NOT_YET_RECRUITING","2025-09-04",{"date":90,"type":91},"2025-09-05","ACTUAL",{"date":93,"type":75},"2025-10-01",{"date":95,"type":75},"2030-02-01",{"name":5,"class":6},1]