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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 (V-COSMOS)

18 de mayo de 2026 actualizado por: Ghanim Khatib, Cukurova University

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

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.

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

160

Contactos y Ubicaciones

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Estudio Contacto

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Histologically confirmed endometrial cancer on preoperative endometrial biopsy

Descripción

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

Plan de estudios

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Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Evaluation of Sentinel Lymph Node Detection Rates in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
Periodo de tiempo: Baseline (pre-procedure), perioperative/periprocedural period
Baseline (pre-procedure), perioperative/periprocedural period

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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 Laparoscopy
Periodo de tiempo: Baseline (pre-procedure), perioperative/periprocedural period
Baseline (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 Laparoscopy
Periodo de tiempo: up to 5 years
The 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.
up to 5 years
The Impact of Sentinel Lymph Node Applications on Overall Survival in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
Periodo de tiempo: Up to 10 years
The 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.
Up to 10 years
Evaluation of Surgical Complications in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
Periodo de tiempo: Baseline (pre-procedure), perioperative/periprocedural period
Baseline (pre-procedure), perioperative/periprocedural period

Colaboradores e Investigadores

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Patrocinador

Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

19 de mayo de 2026

Finalización primaria (Estimado)

30 de abril de 2028

Finalización del estudio (Estimado)

30 de abril de 2036

Fechas de registro del estudio

Enviado por primera vez

22 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2026

Publicado por primera vez (Actual)

13 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

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SÍ

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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