RecruitingNot ApplicableNCT06870903

Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Enrollment

52 participants

Start Date

Mar 15, 2025

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer Sentinel Lymph Node Biopsy Minimally Invasive Surgical Procedures Lymphadenectomy Natural Orifice Transluminal Endoscopic Surgery

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: FEMALEMin Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

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.
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 Criteria4

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

Interventions

PROCEDUREExtraperitoneal(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).

PROCEDURETransperitoneal 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.