[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100439238":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":24,"locations":31,"responsibleParty":46,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":11,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":74,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Chang Gung Memorial Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Laparoscopic radical hysterectomy","EXPERIMENTAL",null,[13],"Procedure: radical hysterectomy",{"label":15,"type":16,"description":11,"interventionNames":17},"Laparotomic radical hysterectomy","ACTIVE_COMPARATOR",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"PROCEDURE","radical hysterectomy","To compare disease-free survival and overall survival of patients with early stage cervical cancer undergoing total laparoscopic radical hysterectomy versus total abdominal radical hysterectomy",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Chyi-Long Lee, MD-PHD","CONTACT","+886-3-328-1200","5400","leechyilong@gmail.com",[32],{"facility":5,"status":11,"city":33,"state":11,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Taoyuan","333","Taiwan","TW",{"type":38,"coordinates":39},"Point",[40,41],121.29696,24.99368,{"lat":41,"lon":40},[44],{"name":45,"role":27,"phone":28,"phoneExt":29,"email":30},"LEE Chyi-Long, MD-PHD",{"type":47,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100439238","minimally-invasive-therapy-versus-open-radical-hysterectomy-for-management-of-early-stage-cervical-cancer-100439238",false,"NCT04999696","Minimally Invasive Therapy Versus Open Radical Hysterectomy for Management of Early Stage Cervical Cancer","Minimally Invasive Therapy Versus Open Radical Hysterectomy (MITOR) for Management of Early Stage Cervical Cancer","MITOR","Inclusion Criteria:\n\n1. Patients with histologically confirmed primary squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix\n2. Patients with histologically confirmed stage IAI (+) LVSI, IA2, IB1, IB2 and IIA1 disease (TNM and 2018 FIGO staging for carcinoma of the uterine cervix)\n3. Patients undergoing a Type II\u002FType III radical hysterectomy (Piver-Rutledge Classification) or Type B\u002FType C radical hysterectomy (Querleu-Morrow Classification)\n4. Patients with adequate bone marrow, renal and hepatic function using Standard International Units 4.1 WBC \\> 3.0 x 109 cells\u002FL 4.2 Platelets \\> 100 x 109 cells\u002FL 4.3 Creatinine \\\u003C 2.0 mg\u002FdL 4.4 Bilirubin \\\u003C 1.5 x upper normal limit and AST\u002FSGOT or ALT\u002FSGPT \\\u003C 3 x upper normal limit\n5. ECOG Performance Status of 0 or 1\n6. Patients who have signed an approved Informed Consent\n7. Patients with a prior malignancy if \\> 5 years ago with no current evidence of disease\n8. Females aged 18 years or older\n9. Negative serum pregnancy test ≤ 30 days of surgery in premenopausal women and women \\\u003C 2 years after the onset of menopause\n\nExclusion Criteria:\n\n1. Patients with any histology other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix\n2. Stage IB3, IIA2-IV (TNM and 2018 FIGO staging for carcinoma of the uterine cervix)\n3. Patients with evidence of metastatic disease by conventional imaging studies (CT Scan, MRI or PET CT Scan), enlarged pelvic or aortic lymph nodes \\> 2cm, or histologically positive lymph nodes\n4. Patients with a history of pelvic or abdominal radiotherapy\n5. Uterine size larger than 12 cm in length\n6. Patients with contraindications to surgery or who are unfit for surgery with serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)","FEMALE","18 Years",{"count":59,"type":60},820,"ESTIMATED","INTERVENTIONAL",[63],"NA","Radical hysterectomy and pelvic lymph node dissection (+\u002F- aortic lymph node dissection) is the standard treatment for early stage cervical cancer. And minimally invasive surgery has been successfully and safely demonstrated in the treatment of early stage cervical cancer. This study aims to compare total laparoscopic radical hysterectomy and total abdominal radical hysterectomy in terms of disease-free survival and overall survival. Rates and characteristics of recurrence, incidence of complications and morbidity, impact on quality of life and cost-effectiveness will also be determined.",[66,67],"Cancer of Cervix","Laparoscopic Surgery",[69,70,71,72,73],"Cervical cancer","Radical hysterectomy","Laparotomy","Laparoscopy","Outcome","NOT_YET_RECRUITING","2023-02-08",{"date":77,"type":78},"2023-02-10","ACTUAL",{"date":80,"type":60},"2023-09",{"date":82,"type":60},"2033-07",{"name":5,"class":6},1]