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

Study acronym: ENDONOTE
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated March 20, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary endpoints revised (15)
    • Interventions: Extraperitoneal( transvaginal retroperitoneal sentinel lymphadenectomy) group lymphadenectomy (Procedure), Transperitoneal lymphadenectomy… to Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy (Procedure), Transperitoneal lymphadenectomy…
    • Eligibility criteria shortened, about 20 words
    • Secondary endpoints revised (7)
    • Study description revised
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06870903
Lead Sponsor Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Conditions
(from sponsor)		 Endometrial Cancer, Lymphadenectomy, Sentinel Lymph Node Biopsy, Minimally Invasive Surgical Procedures, Natural Orifice Transluminal Endoscopic Surgery
Related terms Endometrial Neoplasms
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov