Comparing two surgical approaches for lymphadenectomy in endometrial cancer
Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer
This study is testing two different surgical methods for removing lymph nodes in women with early-stage endometrial cancer to see which one works better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital Academic / other |
| Locations | 1 site (Diyarbakır, Baglar) |
| Trial ID | NCT06870903 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two surgical approaches, transvaginal paracervical and transperitoneal lymphadenectomy, during the staging surgery for endometrial cancer using the innovative V-NOTES technique. Patients diagnosed with early-stage endometrial cancer will be randomly assigned to one of the two groups to evaluate surgical and functional outcomes. The study is designed to optimize the V-NOTES technique by assessing the feasibility and outcomes of each approach in a controlled setting. It will take place at Diyarbakır Gazi Yaşargil Training and Research Hospital, a tertiary cancer treatment facility.
Who should consider this trial
Good fit: Ideal candidates are patients with newly diagnosed early-stage (FIGO stages 1 and 2) endometrial cancer scheduled for laparoscopic surgical staging.
Not a fit: Patients with advanced-stage endometrial cancer or those not eligible for laparoscopic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced morbidity for patients undergoing treatment for endometrial cancer.
How similar studies have performed: While there is limited comparative data on the specific approaches being tested, the use of V-NOTES in surgical procedures has shown promise in reducing morbidity in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Inclusion criteria will include * 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 criteria will include: * 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
Where this trial is running
Diyarbakır, Baglar
- Gazi Yasargil Training And Research Hospital — Diyarbakır, Baglar, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Kevser Arkan, MD — Health Sciences University Gazi Yasargil Training and Research Hospital
- Study coordinator: Kevser Arkan, MD
- Email: kevser.toprak1989@gmail.com
- Phone: +905536476838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.