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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCukurova University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Presence of extrauterine disease

Detection of distant metastasis

Surgery performed via an open (laparotomy) approach

Incomplete medical records

Trial population

Histologically confirmed endometrial cancer on preoperative endometrial biopsy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Evaluation of Sentinel Lymph Node Detection Rates in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy

Time frame
Baseline (pre-procedure), perioperative/periprocedural period

Secondary outcomes

1

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

Time frame
Baseline (pre-procedure), perioperative/periprocedural period
2

The Impact of Sentinel Lymph Node Applications on Progression-Free Survival in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy

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.

Time frame
up to 5 years
3

The Impact of Sentinel Lymph Node Applications on Overall Survival in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy

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.

Time frame
Up to 10 years
4

Evaluation of Surgical Complications in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy

Time frame
Baseline (pre-procedure), perioperative/periprocedural period

Other outcomes

Sponsors and contacts

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