[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"natural-orifice-transluminal-endoscopic-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:natural-orifice-transluminal-endoscopic-surgery":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100430570","vaginal-notes-hysterectomy-versus-vaginal-hysterectomy-100430570",false,"NCT04886791","Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy","Vaginal Hysterectomy Versus Vaginal Assisted NOTES Hysterectomy (VANH): a Randomised Controlled Trial","VANH","Inclusion Criteria:\n\n* Written and orally given informed consent\n* 18 years and older\n* Native Dutch speaker or in control of the Dutch language in speaking and writing\n* Indication for hysterectomy for benign indication\n* Possible to perform a VH judged by experienced (resident) gynaecologist during gynaecological examination\n\nExclusion Criteria:\n\n* Any contra-indication for VH (for example, large uterus myomatosus, not enough descensus, etc) as judged by experienced gynaecologist\n* History of more than 1 caesarean section\n* History of endometriosis\n* History of rectal surgery\n* History of pelvic radiation\n* Suspected rectovaginal endometriosis\n* History of pelvic inflammatory disease, especially prior tubo-ovarian or pouch of Douglas abscess or suspected adhesions due to (ruptured) inflammatory disease (for example ruptured appendicitis)\n* Virginity\n* Pregnancy\n* Indication for anterior or posterior colporrhaphy during the same surgery\n* Indication of mid urethral slings\n* Uterus myomatosus will not be an exclusion criteria but the surgeon will indicate if it is possible to remove the uterus vaginally.","FEMALE","18 Years",{"count":20,"type":21},124,"ESTIMATED","INTERVENTIONAL",[24],"NA","Rationale: Natural orifice transluminal endoscopic surgery (NOTES) is a minimal invasive technique using the natural body orifices like stomach, oesophagus, bladder, rectum and vagina to access the human body for surgery. In 2012, the first vaginal NOTES (vNOTES) hysterectomy was performed. Potential benefits of vNOTES hysterectomy, also called the vaginal assisted NOTES hysterectomy (VANH) are no visible scars, less pain and a shorter hospital stay compared with laparoscopic hysterectomy as shown in the HALON trial. Up to now, no studies have compared the vNOTES hysterectomy with vaginal hysterectomy.\n\nObjective: The aim of this study is to compare the vNOTES hysterectomy with the vaginal hysterectomy for same day-discharge (SDD), complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness.\n\nStudy design: The study concerns a single-blinded, multicentre, randomised controlled trial.\n\nStudy population: Eligible women who fulfill the inclusion criteria and will undergo a hysterectomy for benign indication.\n\nIntervention: The study population will be randomly allocated to the VANH-group, who undergo a vaginal assisted NOTES hysterectomy (intervention group) or the vaginal hysterectomy group (control-group) and the participants will be single blinded. The pre- and postoperative care will be the same for both groups.\n\nMain study parameters\u002Fendpoints: Primary outcome is the percentage of patients that underwent the hysterectomy as in SDD setting. A total of 41 patients should be included in the control group and a total of 83 patients in the intervention group, using an enrollment ratio of 1:2, with an alpha of 0.05 and a power of 0.8.\n\nThe secondary outcomes are complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness:\n\nvNOTES is a new surgical technique, but a combination of two existing techniques namely the vaginal hysterectomy and the laparoscopic hysterectomy. Only one randomized controlled trial has been published, comparing the total laparoscopic hysterectomy (TLH) with the VANH, which shows no inferiority of the vNOTES technique compared to a laparoscopy. A recent case series study has been published about the complication rate in VANH. There was a total complication rate in the hysterectomy group of 5.2%, in which 1.4% was intra-operative and 3.8% postoperative. Theoretically it is possible that the VANH causes less intra-operative complications because of an improved view during the procedure. No further literature is known about VH versus VANH. Participants of the study should fill in multiple questionnaires before randomization and postoperative about their general health, pain experience and used analgesics.",[27,28,29],"Hysterectomy","Natural Orifice Transluminal Endoscopic Surgery","Vaginal Hysterectomy",[31,32,15,33,27],"NOTES surgery","vNOTES","Vaginal hysterectomy","RECRUITING","2025-08-13",{"date":37,"type":38},"2025-08-14","ACTUAL",{"date":40,"type":38},"2021-07-05",{"date":42,"type":21},"2025-12-31",{"name":44,"class":45},"Zuyderland Medisch Centrum","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100583021","comparison-of-transvaginal-paracervical-and-transperitoneal-approaches-in-lymphadenectomy-during-v-notes-surgery-for-patients-diagnosed-with-endometrial-cancer-100583021","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","85 Years",{"count":55,"type":21},52,[24],"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.",[59,60,61,62,28],"Endometrial Cancer","Lymphadenectomy","Sentinel Lymph Node Biopsy","Minimally Invasive Surgical Procedures",[64,65,66,67,68,69],"endometrial cancer","V-NOTES","lymphadenectomy","sentinel lymph node","transperitoneal","extraperitoneal","2025-03-17",{"date":72,"type":38},"2025-03-20",{"date":74,"type":38},"2025-03-15",{"date":76,"type":21},"2026-03-01",{"name":78,"class":45},"Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital",1]