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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy
  • Transperitoneal lymphadenectomy

Treatment groups

52 Participants
are divided into 2 treatment groups