Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer
Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomyTransperitoneal lymphadenectomy
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).
Transperitoneal lymphadenectomy: 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.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.
Between 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/institutional review board of Diyarbakır Gazi Yaşargil Training and Research Hospital and informed consent signed by the patient will be included in each table reviewed.
Eligible participants will be required to give informed consent to participate in the study.
Inclusion criteria will include
* 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/CT)
* Absence of synchronous malignancies.
* No neoadjuvant treatment before surgical intervention.
Exclusion criteria will include:
* Contraindications to using methylene blue dye or contraindications to the vNOTES procedure.
* Patients who have had previous malignancy surgery.
* Severe, deeply penetrating endometriosis or enlarged uterus that may require forced vaginal extraction
* Receiving neodajuvant therapy
Primary outcome measure(s)
Total operation duration — During surgery The total duration of the operation in minutes
Duration of right and left lymphadenectomy — During surgery The duration of lymphadenectomies in minutes
Number of lymph nodes excised — Postoperative second week Lymph node count in the pathology report
number of positive lymph nodes — Postoperative second week Sentinel positive lymph nodes in the pathology report
Hospitalization duration — During hospital stay Number of days patients stayed at the hospital postoperatively
Total bleeding volume — During surgery Measured by the suction bottle's volume and number of surgical gauzse used during surgery
Difference between pre- and postoperative hemoglobin values — Postoperative 1st day Hemoglobin level (g/dL)
Surgical complications — During hospital stay Clavien dindo scale of surgical complications
Location o SLN — During surgery The area that sentinel lymph node detected internal iliac, external iliac ,bifurcation or obturator fossa
Preoperative and postoperative hematocrit values — During hospital stay Hematocrit level (%)
Tumor's patological features — Postoperative second week Histophatology, grade, lymphovascular invasion, tumor diameter(cm), myometrial invasion, stage, total positive lymph node count
Management of complications — through study completion intraoperative and postoperative complication's management
Duration of lateral colpotomy — During surgery at transvaginal retroperitoneal procedure ; before the lymphadenectomy we are making and incision to the lateral of cervix .this time describes the time that to reach the obturator fossa to pick the nodes.
Duration of hysterectomy — During surgery minutes
Sentinel lymphnode's side and number — Postoperative second week number
Trial sites (1)
Facility
City
Region
Status
Gazi Yasargil Training And Research Hospital
Diyarbakır
Baglar
Recruiting
More Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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