[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583021":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":41,"locations":46,"responsibleParty":65,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":91,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"transvaginal paracervical sentinel lymphadenectomy group","EXPERIMENTAL","Surgical Procedure of transvaginal sentinel lymphadenectomy group:\n\nAll patients will be operated in accordance with Memorial Sloan Kettering Cancer Center procedure. V-NOTES will consist of transvaginal paracervical sentinel lymph node (SLN) mapping followed by V-NOTES hysterectomy and bilateral salpingo-oophorectomy (BSO).\n\nSLN Mapping:\n\nUnder general anesthesia, subjects will be placed in supine lithotomy position. Methylene blue solution (BLUMET IV INJECTION INJECTABLE 50 mg\u002F5 ml 1x5 ml) (1 mL submucosal to the cervix at the 3 and 9 o'clock positions and 1 mL at a depth of 1-2 cm, using a total volume of 2-4 mL.\n\nMonitoring of lymphatic ducts includes identification of structures stained with methylene blue dye in the expected anatomical location, typically between the internal and external iliac veins or in the obturator region. Bilateral and symmetrical structures believed to be sentinel lymph nodes (SLNs) will be removed. When unilate",[13],"Procedure: Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy",{"label":15,"type":16,"description":17,"interventionNames":18},"Transperitoneal lymphadenectomy","ACTIVE_COMPARATOR","In this arm, patients will undergo transperitoneal lymphadenectomy with V-NOTES. The procedure begins with methylene blue injection for sentinel lymph nodes. Methylene blue will be injected at the 3 and 9 o'clock positions on the cervix, first at a depth of 1 mm and then at 4 mm, with 1 cc administered at each point. This will result in a total of 4 cc (1 cc x 4). Then, the procedure will continue with anterior and posterior colpotomies, followed by placement of the V-NOTES apparatus. Hysterectomy is performed first, followed by peritoneal dissection and lymph node excision.",[19],"Procedure: Transperitoneal lymphadenectomy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy","The procedure begins with a vaginal incision in the lateral vaginal fornices (on both sides), which is then extended to allow placement of the V-NOTES apparatus. By identifying an appropriate cleavage plane, the obturator fossa is accessed to excise the obturator lymph nodes. Following this, an anterior colpotomy is performed to access the vesicocervical space, and a posterior colpotomy is made to open the rectouterine pouch. The V-NOTES apparatus is then placed to continue with the hysterectomy and bilateral salpingo-oophorectomy (BSO).",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"In this arm, patients will undergo transperitoneal lymphadenectomy with V-NOTES. The procedure begins with anterior and posterior colpotomies, followed by placement of the V-NOTES apparatus. Hysterectomy is performed first, followed by peritoneal dissection and lymph node excision.",[15],[31,35,38],{"name":32,"affiliation":33,"role":34},"Behzat Can, Assoc. Prof.","Health Sciences University Gazi Yasargil Training and Research Hospital","STUDY_CHAIR",{"name":36,"affiliation":33,"role":37},"Sedat Akgol, Assoc. Prof.","STUDY_DIRECTOR",{"name":39,"affiliation":33,"role":40},"Kevser Arkan, MD","PRINCIPAL_INVESTIGATOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":26,"email":45},"CONTACT","+905536476838","kevser.toprak1989@gmail.com",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":26,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Gazi Yasargil Training And Research Hospital","RECRUITING","Diyarbakır","Baglar","21090","Turkey (Türkiye)",{"type":55,"coordinates":56},"Point",[57,58],40.21721,37.91363,{"lat":58,"lon":57},[61,63],{"name":26,"role":43,"phone":26,"phoneExt":62,"email":45},"+90 5536476838",{"name":64,"role":43,"phone":26,"phoneExt":26,"email":26},"Sedat Akgol",{"type":40,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Sedat Akgöl","Head of Gynecology Oncology Department","100583021","comparison-of-transvaginal-paracervical-and-transperitoneal-approaches-in-lymphadenectomy-during-v-notes-surgery-for-patients-diagnosed-with-endometrial-cancer-100583021",false,"NCT06870903","Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer","ENDONOTE","Patient Selection and Data Collection This study will be implemented in a single institution, Diyarbakır Gazi Yaşargil Training and Research Hospital, which functions as a tertiary cancer treatment facility.\n\nBetween March 2025 and December 2025, patients with newly diagnosed clinical early stage (FIGO 2023 stages 1 and 2) endometrial cancer who will be treated with laparoscopic surgical staging with SLN mapping at our institution will be randomized into groups. The research procedure has been approved by the ethics committee\u002Finstitutional review board of Diyarbakır Gazi Yaşargil Training and Research Hospital and informed consent signed by the patient will be included in each table reviewed.\n\nEligible participants will be required to give informed consent to participate in the study.\n\nInclusion criteria will include\n\n* Participants whose endometrial biopsy resulted in endometrial cancer and whose disease will be detected limited to the uterus using imaging modalities (computed tomography \\[CT\\], magnetic resonance imaging or Fluorine-18 fluorodeoxyglucose positron emission tomography\u002FCT)\n* Absence of synchronous malignancies.\n* No neoadjuvant treatment before surgical intervention.\n\nExclusion criteria will include:\n\n* Contraindications to using methylene blue dye or contraindications to the vNOTES procedure.\n* Patients who have had previous malignancy surgery.\n* Severe, deeply penetrating endometriosis or enlarged uterus that may require forced vaginal extraction\n* Receiving neodajuvant therapy","FEMALE","18 Years","85 Years",{"count":79,"type":80},52,"ESTIMATED","INTERVENTIONAL",[83],"NA","The aim of this study is to compare two types of lymphadenectomy (transperitoneal vs. paracervical) during the lymphadenectomy phase of endometrial cancer staging surgery performed using V-NOTES, a new and advanced technique. This study seeks to optimize the V-NOTES technique for endometrial cancer staging. This randomized, prospective, controlled study will include patients diagnosed with endometrial cancer via histology, following physical examination and imaging, and who are electively scheduled for the V-NOTES endometrial cancer staging procedure. Patients will be randomized into two groups: the transvaginal paracervical lymphadenectomy group and the transperitoneal lymphadenectomy group. The parameters related with surgical and functional outcomes will be compared in both groups.",[86,87,88,89,90],"Endometrial Cancer","Lymphadenectomy","Sentinel Lymph Node Biopsy","Minimally Invasive Surgical Procedures","Natural Orifice Transluminal Endoscopic Surgery",[92,93,94,95,96,97],"endometrial cancer","V-NOTES","lymphadenectomy","sentinel lymph node","transperitoneal","extraperitoneal","2025-03-17",{"date":100,"type":101},"2025-03-20","ACTUAL",{"date":103,"type":101},"2025-03-15",{"date":105,"type":80},"2026-03-01",{"name":5,"class":6},1]