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

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical approaches for removing lymph nodes during a minimally invasive (vaginal) operation for early-stage uterine (endometrial) cancer, to determine which is safer and more effective. **You may be eligible if...** - You have been newly diagnosed with early-stage endometrial (uterine) cancer (FIGO 2023 stages 1 or 2) - Imaging tests (CT, MRI, or PET scan) show the cancer appears to be limited to the uterus - You have not had any treatment before surgery (no neoadjuvant chemotherapy or radiation) - You do not have any other active cancers - You are willing to give informed consent **You may NOT be eligible if...** - Your cancer has spread beyond the uterus based on imaging - You have received neoadjuvant treatment before surgery - You have another simultaneous cancer diagnosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

Gazi Yasargil Training And Research Hospital

Diyarbakır, Baglar, Turkey (Türkiye)

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NCT06870903

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