Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer

NCT06870903RecruitingNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Enrollment

52

Start Date

2025-03-15

Completion Date

2025-12-31

Study Type

INTERVENTIONAL

Official Title

Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer

Interventions

Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomyTransperitoneal lymphadenectomy

Conditions

Endometrial CancerLymphadenectomySentinel Lymph Node BiopsyMinimally Invasive Surgical ProceduresNatural Orifice Transluminal Endoscopic Surgery

Eligibility

Age Range

18 Years – 85 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Total operation duration

The total duration of the operation in minutes

Time frame: During surgery

Duration of right and left lymphadenectomy

The duration of lymphadenectomies in minutes

Time frame: During surgery

Number of lymph nodes excised

Lymph node count in the pathology report

Time frame: Postoperative second week

number of positive lymph nodes

Sentinel positive lymph nodes in the pathology report

Time frame: Postoperative second week

Hospitalization duration

Number of days patients stayed at the hospital postoperatively

Time frame: During hospital stay

Total bleeding volume

Measured by the suction bottle's volume and number of surgical gauzse used during surgery

Time frame: During surgery

Difference between pre- and postoperative hemoglobin values

Hemoglobin level (g/dL)

Time frame: Postoperative 1st day

Surgical complications

Clavien dindo scale of surgical complications

Time frame: During hospital stay

Location o SLN

The area that sentinel lymph node detected internal iliac, external iliac ,bifurcation or obturator fossa

Time frame: During surgery

Preoperative and postoperative hematocrit values

Hematocrit level (%)

Time frame: During hospital stay

Tumor's patological features

Histophatology, grade, lymphovascular invasion, tumor diameter(cm), myometrial invasion, stage, total positive lymph node count

Time frame: Postoperative second week

Management of complications

intraoperative and postoperative complication's management

Time frame: through study completion

Duration of lateral colpotomy

at transvaginal retroperitoneal procedure ; before the lymphadenectomy we are making and incision to the lateral of cervix .this time describes the time that to reach the obturator fossa to pick the nodes.

Time frame: During surgery

Duration of hysterectomy

minutes

Time frame: During surgery

Sentinel lymphnode's side and number

number

Time frame: Postoperative second week

Secondary Outcomes

Postoperative pain

visual analogue scale, higher scores indicate worse pain

Time frame: 3rd and 6th month after operation

Sexual function

assessed by Female Sexual Function Index, higher scores indicate greater satisfaction

Time frame: at postoperative 3rd and 6th month

Timing of passing gas

Bowel function

Time frame: During hospital stay

Demographic features

Age, gravidity, parity, previous vaginal delivery, body-mass index

Time frame: Postoperative second week

Previous abdominal surgery

Medical history

Time frame: Preoperative day

Initiation of mobilization

After operation the time (hour) that paient is avaliable to mobilize out from the bed

Time frame: During hospital stay

6th hour and 24th hour VAS score

The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

Time frame: postoperatively 6th and 24th hours score

Locations

Gazi Yasargil Training And Research Hospital, Diyarbakır, Turkey (Türkiye)

Linked Papers

2024-04-16

vNOTES retroperitoneal sentinel lymph node dissection for endometrial cancer staging: First multicenter, prospective case series

AbstractIntroductionThe current standard treatment for endometrial cancer is a laparoscopic hysterectomy with adnexectomies and bilateral sentinel node resection. A retroperitoneal vNOTES sentinel node resection has several theoretical potential advantages. These include being less invasive, leaving no visible scars, operating without Trendelenburg, and therefore offering the anesthetic advantage of easier ventilation in obese patients and following the natural lymph node trajectory from caudally to cranially and therefore a lower risk of missing the sentinel node. The aim of this study is to determine the feasibility of a retroperitoneal vNOTES approach to sentinel lymph node dissection for staging of endometrial cancer.Material and methodsA prospective multicenter case series was performed in four hospitals. A total of 64 women with early‐stage endometrial carcinoma suitable for surgical staging with sentinel lymph node removal were operated via a transvaginal retroperitoneal vNOTES approach. The paravesical space was entered through a vaginal incision after injecting the cervix with indocyanine green. A vNOTES port was placed into this space and insufflation of the retroperitoneum was performed. Sentinel lymph nodes were identified bilaterally using near‐infrared light followed by endoscopic removal of these nodes.ResultsA total of 64 women with early‐stage endometrial cancer underwent sentinel lymph node removal by retroperitoneal vNOTES technique. All patients also underwent subsequent vNOTES hysterectomy and bilateral salpingo‐oophorectomy. The median age was 69.5 years, median total operative time was 126 min and the median estimated blood loss was 80 mL. In 97% of the cases bilateral sentinel nodes could be identified. A total of 60 patients had negative sentinel nodes, three had isolated tumor cells and one had macroscopically positive sentinel nodes. No complications with sequel occurred.ConclusionsThis prospective multicenter case series demonstrates the feasibility of the vNOTES approach for identifying and removing sentinel lymph nodes in women with endometrial carcinoma successfully and safely. vNOTES allows sole transvaginal access with exposure of the entire retroperitoneal space, following the natural lymph trajectory caudally to cranially, and without the need for a Trendelenburg position.

2023-10-01

Efficacy of vaginal natural orifice transluminal endoscopic sentinel lymph node biopsy for endometrial cancer: a prospective multicenter cohort study

Introduction: Natural orifice transluminal endoscopic surgery (NOTES) is performed increasingly often despite the lack of high-quality evidence confirming its safety, especially for malignant diseases. The aim of this prospective study is to verify that vaginal NOTES (vNOTES) can be performed safely and effectively in early endometrial cancer staging surgery. Materials and Methods: This prospective study was conducted in two tertiary hospitals in southern China from January 2021 to May 2022. A total of 120 patients with stage I endometrial cancer were included. vNOTES or multiport laparoscopic staging surgery was selected according to each patient’s wishes. The primary outcome was the sentinel lymph node detection rate, analyzed by a noninferiority test. The secondary outcomes were perioperative outcomes. Results: Among the 120 patients enrolled, 57 underwent vNOTES, and 63 underwent multiport laparoscopy. The patient-specific detection rates of sentinel lymph nodes were 94.73 and 96.82% in the vNOTES and laparoscopy groups, respectively. Additionally, the bilateral detection rates were 82.46 and 84.13%, and the side-specific detection rates were 88.60 and 90.48% in these two groups, respectively. All three detection rates in the vNOTES group were noninferior to those of laparoscopy group at a noninferiority cutoff of –15%. The median operation times of the vNOTES and laparoscopy groups were 132.35 and 138.73 min (P=0.362), and the median estimated blood loss were 75 and 50 ml (P=0.096), respectively. No intraoperative complications occurred in either group. The pain scores on the Numerical Rating Scale at both 12 h and 24 h after operation were significantly lower in the vNOTES group (P<0.001) and the median postoperative hospital stay was significantly shorter in the vNOTES group (P=0.001). Conclusion: This study illustrates the potential applicability of vNOTES in gynecological malignancy surgery by demonstrating its safety and effectiveness in endometrial cancer staging. However, its long-term survival outcomes require further exploration.

Linked Investigators