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Comparison of Sentinel Lymph Node Applications in Endometrial Cancer Cases Performed With Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) and Conventional Laparoscopy

Comparison of Sentinel Lymph Node Applications in Endometrial Cancer Cases Performed With V-NOTES and Conventional Laparoscopy: A Multicenter Prospective Observational Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07583329
Acronym
V-COSMOS
Enrollment
160
Registered
2026-05-13
Start date
2026-05-19
Completion date
2036-04-30
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Adenocarcinoma, Endometrial Cancer

Keywords

v-notes, sentinel lymph node, conventional laparoscopy

Brief summary

Endometrial cancer is a common cancer in women, and surgery is usually the first step in treatment. During surgery, doctors often check nearby lymph nodes to see if the cancer has spread. A newer method called sentinel lymph node (SLN) mapping allows doctors to examine only the first few lymph nodes most likely to contain cancer. This can reduce the need for removing many lymph nodes and may lower the risk of complications. Minimally invasive surgery is commonly performed using small abdominal incisions (laparoscopy). A newer technique, called vaginal natural orifice transluminal endoscopic surgery (vNOTES), allows the surgery to be performed through the vagina without any cuts on the abdomen. This approach may lead to less pain, quicker recovery, and no visible scars. This study will compare these two surgical methods-laparoscopy and vNOTES-in patients with early-stage endometrial cancer. Researchers will look at how safe and effective each method is, how patients recover after surgery, and how well the sentinel lymph node procedure works with each technique. The study will also examine how quickly surgeons become experienced with the newer vNOTES method. The goal of this research is to determine whether vNOTES can be a safe and effective alternative to standard laparoscopic surgery, while offering potential benefits for patients.

Detailed description

Endometrial cancer is one of the most common malignancies of the female genital tract, and surgical staging constitutes the cornerstone of its management. In recent years, sentinel lymph node (SLN) mapping has been increasingly used as an alternative to systematic pelvic and paraaortic lymphadenectomy. The SLN approach reduces unnecessary extensive lymph node dissections, thereby decreasing surgical morbidity while enabling reliable assessment of lymphatic spread. With the advancement of minimally invasive surgery, conventional laparoscopy has become widely used in the surgical management of endometrial cancer. In recent years, however, transvaginal natural orifice transluminal endoscopic surgery (vNOTES) has been increasingly adopted in gynecologic surgery due to its potential advantages, including the absence of abdominal incisions, reduced postoperative pain, faster recovery, and improved cosmetic outcomes. Nevertheless, prospective data comparing the vNOTES approach with conventional laparoscopy-particularly in terms of SLN mapping success and surgical outcomes-remain limited. The aim of this study is to comparatively evaluate the feasibility, efficacy, safety, perioperative outcomes, and impact on survival of retroperitoneal sentinel lymph node biopsy (SLNB) performed using two different minimally invasive surgical approaches-standard conventional laparoscopy and vNOTES-in patients diagnosed with endometrial cancer that is clinically and radiologically presumed to be confined to the uterus. Another objective is to assess the learning curve of surgeons for the relatively new vNOTES technique in relation to the number of cases performed. The primary hypothesis of the study is that SLNB performed via the vNOTES approach is a safe, effective, and feasible minimally invasive surgical alternative compared to conventional laparoscopy.

Interventions

None listed

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥18 years * Histologically confirmed endometrial cancer on preoperative endometrial biopsy * Disease confirmed to be confined to the uterus based on clinical evaluation and imaging * No evidence of lymphatic or distant metastasis on positron emission tomography/computed tomography(PET/CT) or magnetic resonance imaging (MRI) * Surgical staging with sentinel lymph node biopsy recommended by a multidisciplinary tumor board * Surgical treatment performed using either conventional laparoscopy or the vNOTES approach

Exclusion criteria

* Presence of extrauterine disease * Detection of distant metastasis * Surgery performed via an open (laparotomy) approach * Incomplete medical records * History of prior pelvic radiotherapy

Design outcomes

Primary

MeasureTime frame
Evaluation of Sentinel Lymph Node Detection Rates in Endometrial Cancer Cases Performed with V-NOTES and Conventional LaparoscopyBaseline (pre-procedure), perioperative/periprocedural period

Secondary

MeasureTime frameDescription
The Relationship Between Case Volume and the Learning Curve of Surgeons for Sentinel Lymph Node Procedures in Endometrial Cancer Cases Performed with V-NOTES and Conventional LaparoscopyBaseline (pre-procedure), perioperative/periprocedural period
The Impact of Sentinel Lymph Node Applications on Progression-Free Survival in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopyup to 5 yearsThe impact of sentinel lymph node applications on progression-free survival in endometrial cancer cases performed with V-NOTES and conventional laparoscopy will be evaluated over a follow-up period of 5 years. Progression-free survival is defined as the time from surgery to the first documented disease recurrence, progression, or death from any cause.
The Impact of Sentinel Lymph Node Applications on Overall Survival in Endometrial Cancer Cases Performed with V-NOTES and Conventional LaparoscopyUp to 10 yearsThe impact of sentinel lymph node applications on overall survival in endometrial cancer cases performed with V-NOTES and conventional laparoscopy will be evaluated over a follow-up period of 10 years. Overall survival is defined as the time from surgery to death from any cause.
Evaluation of Surgical Complications in Endometrial Cancer Cases Performed with V-NOTES and Conventional LaparoscopyBaseline (pre-procedure), perioperative/periprocedural period

Countries

Turkey (Türkiye)

Contacts

CONTACTGhanim Khatib
ghanim.khatib@gmail.com+903223386060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026