[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612699":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":49,"collaborators":52,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":24,"enrollmentInfo":89,"targetDuration":24,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":110,"whyStopped":24,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Open radical hysterectomy","EXPERIMENTAL","Radical hysterectomy is performed via open surgery",[13],"Device: Open radical hysterectomy",{"label":15,"type":10,"description":16,"interventionNames":17},"Minimally invasive radical hysterectomy","Radical hysterectomy is performed via minimally invasive surgery",[18],"Device: Minimally invasive radical hysterectomy",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Radical hysterectomy is performed via open surgery, and Wertheim clamp is used for preventing tumor spillage during colpotomy",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Radical hysterectomy is performed via minimally invasive surgery, and an endoscopic stapler is used for preventing tumor spillage during colpotomy",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Hee Seung Kim, Professor","CONTACT","82-2-2072-4863","bboddi0311@snu.ac.kr",[35],{"facility":36,"status":24,"city":37,"state":24,"zip":38,"country":39,"countryCode":24,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Seoul National University College of Medicine","Seoul","03080","South Korea",{"type":41,"coordinates":42},"Point",[43,44],126.9784,37.566,{"lat":44,"lon":43},[47],{"name":48,"role":31,"phone":32,"phoneExt":24,"email":33},"Hee Seung Kim",{"type":50,"investigatorFullName":48,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Clinical Professor",[53,55,57,59,61,63,66,68,70,72,74,76],{"name":54,"class":6},"Ajou University School of Medicine",{"name":56,"class":6},"SMG-SNU Boramae Medical Center",{"name":58,"class":6},"Konkuk University",{"name":60,"class":6},"DongGuk University",{"name":62,"class":6},"Keimyung University",{"name":64,"class":65},"National Cancer Center, Korea","OTHER_GOV",{"name":67,"class":6},"The Catholic University of Korea",{"name":69,"class":6},"Wonju Severance Christian Hospital",{"name":71,"class":6},"Kangbuk Samsung Hospital",{"name":73,"class":6},"Asan Medical Center",{"name":75,"class":6},"Samsung Medical Center",{"name":77,"class":78},"Sinchon Severance Hospital, Yonsei University College of Medicine","UNKNOWN","100612699","minimally-invasive-radical-hysterectomy-using-endoscopic-stapler-in-stage-ib2-or-iia1-cervical-cancer-100612699",false,"NCT07256977","Minimally Invasive Radical Hysterectomy Using Endoscopic Stapler in Stage IB2 or IIA1 Cervical Cancer","A Multicenter Non-inferiority Randomized Controlled Trial on Minimally Invasive Radical Hysterectomy Using an Endoscopic Stapler to Prevent Tumor Spillage in Stage IB2-IIA1 Cervical Cancer","SOLUTION2","I. Inclusion Criteria:\n\n1. 2018 FIGO stage IB2 or IIA1 cervical cancer (tumor maximum diameter ≥2 cm and \\\u003C4 cm)\n2. Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma\n3. Planned for Type B or C radical hysterectomy\n4. With adequate bone marrow, renal, and hepatic function\n\n   * WBC \\>3.0 × 10⁹ cells\u002FL\n   * Platelets \\>100 × 10⁹ cells\u002FL\n   * Creatinine \\\u003C180 μmol\u002FL\n   * Bilirubin \\\u003C1.5 × normal range\n   * AST, ALT \\\u003C 3 × normal range\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n6. Previous history of other invasive malignancies with no evidence of recurrence for at least 5 years\n7. Signed and approved consent form\n\nII. Exclusion Criteria:\n\n1. Histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma\n2. Tumor size less than 2 cm classified as 2018 FIGO stage IA1, IA2, or IB1 disease\n3. The following are observed on preoperative CT or MRI\n\n   * Tumor size ≥4 cm\n   * Lymph node metastasis (short axis ≥15 mm)\n   * Paracervical invasion\n   * Bladder or rectal invasion\n   * Distant metastasis\n4. Prior pelvic or abdominal radiotherapy\n5. Prior neoadjuvant chemotherapy before surgery\n6. Unsuitable for surgery due to severe systemic disease at the investigator's discretion\n7. Difficult to consider intraoperative lymphatic mapping due to\n\n   * Allergy to triphenylmethane compounds\n   * History of prior retroperitoneal surgery\n   * History of prior pelvic radiotherapy\n   * Cases where cold knife or loop electrosurgical excision procedure (LEEP) was performed within 4 weeks prior to study participation\n   * Allergy to triphenylmethane compounds","FEMALE","20 Years",{"count":90,"type":91},494,"ESTIMATED","INTERVENTIONAL",[94],"NA","This study is a multicenter, open-label, non-inferiority, randomized controlled, investigator-initiated clinical trial comparing the efficacy and safety of open radical hysterectomy versus minimally invasive radical hysterectomy using an endoscopic stapler as surgical treatments for early cervical cancer.",[97,98],"Cervical Cancer Stage IB2","Cervical Cancer Stage IIa",[100,101,102,103,104,105,106,107,108,109],"Cervical cancer","open radical hysterectomy","minimally invasive radical hysterectomy","endoscopic stapler","survival","complications","perioperative outcomes","postoperative pain","quality of life","recurrence pattern","NOT_YET_RECRUITING","2025-11-27",{"date":113,"type":114},"2025-12-02","ACTUAL",{"date":116,"type":91},"2026-01-01",{"date":118,"type":91},"2035-06-30",{"name":5,"class":6},1]