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

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.

Conditions

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

Interventions

PROCEDURE

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).

PROCEDURE

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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

  lead OTHER

Principal Investigators

• Behzat Can, Assoc. Prof. · Health Sciences University Gazi Yasargil Training and Research Hospital

• Sedat Akgol, Assoc. Prof. · Health Sciences University Gazi Yasargil Training and Research Hospital

• Kevser Arkan, MD · Health Sciences University Gazi Yasargil Training and Research Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-15

Primary Completion

2025-12-31

Completion

2026-03-01

Countries

• Turkey (Türkiye)

Study Locations