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

ConditionsEndometrial CancerLymphadenectomySentinel Lymph Node BiopsyMinimally Invasive Surgical ProceduresNatural Orifice Transluminal Endoscopic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

About this trial

The aim of this study is to compare two types of lymphadenectomy (transperitoneal vs. paracervical) during the lymphadenectomy phase of endometrial cancer staging surgery performed using V-NOTES, a new and advanced technique. This study seeks to optimize the V-NOTES technique for endometrial cancer staging. This randomized, prospective, controlled study will include patients diagnosed with endometrial cancer via histology, following physical examination and imaging, and who are electively scheduled for the V-NOTES endometrial cancer staging procedure. Patients will be randomized into two groups: the transvaginal paracervical lymphadenectomy group and the transperitoneal lymphadenectomy group. The parameters related with surgical and functional outcomes will be compared in both groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy

    Procedure/Surgery

    The procedure begins with a vaginal incision in the lateral vaginal fornices (on both sides), which is then extended to allow placement of the V-NOTES apparatus. By identifying an appropriate cleavage plane, the obturator fossa is accessed to excise the obturator lymph nodes. Following this, an anterior colpotomy is performed to access the vesicocervical space, and a posterior colpotomy is made to open the rectouterine pouch. The V-NOTES apparatus is then placed to continue with the hysterectomy and bilateral salpingo-oophorectomy (BSO).

  • Transperitoneal lymphadenectomy

    Procedure/Surgery

    In this arm, patients will undergo transperitoneal lymphadenectomy with V-NOTES. The procedure begins with anterior and posterior colpotomies, followed by placement of the V-NOTES apparatus. Hysterectomy is performed first, followed by peritoneal dissection and lymph node excision.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: transvaginal paracervical sentinel lymphadenectomy groupExperimental treatment 1 intervention
Group B: Transperitoneal lymphadenectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total operation duration

The total duration of the operation in minutes

Time frame
During surgery
2

Duration of right and left lymphadenectomy

The duration of lymphadenectomies in minutes

Time frame
During surgery
3

Number of lymph nodes excised

Lymph node count in the pathology report

Time frame
Postoperative second week
4

number of positive lymph nodes

Sentinel positive lymph nodes in the pathology report

Time frame
Postoperative second week

Secondary outcomes

1

Postoperative pain

visual analogue scale, higher scores indicate worse pain

Time frame
3rd and 6th month after operation
2

Sexual function

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

Time frame
at postoperative 3rd and 6th month
3

Timing of passing gas

Bowel function

Time frame
During hospital stay
4

Demographic features

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

Time frame
Postoperative second week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Lead sponsor

Source ClinicalTrials.gov
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