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NCT Number: NCT06870903

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gazi Yasargil Training And Research Hospital

Diyarbakır, Baglar, 21090, Turkey (Türkiye)

Location status: Recruiting

Location contact

Sedat Akgol

CONTACT

CONTACT

[email protected]

About this study

Surgical staging is often the primary management strategy for endometrial cancer. Sentinel lymph node (SLN) procedures are considered an alternative standard of care in the treatment of significant uterus-confined malignancy. Both accurately estimate nodal status and reduce the surgical morbidity associated with complete lymphadenectomy. Laparoscopic surgery for endometrial cancer has been associated with equal or better quality of life, less blood loss and similar cancer-related outcomes. A new innovation, natural orifice transluminal endoscopic surgery (NOTES), has been developed to further reduce morbidity and scarring associated with laparoscopic surgery. NOTES utilizes the natural orifices of the human body for access to the peritoneal cavity when performing endoscopic surgery.

However, there is no standardization in vNOTES SLN mapping and lymph tracers are diverse. Many procedures and tracers have been reported, such as intra- or retroperitoneal surgery, a range of vaginal surgeries, SLN exposure method, and indocyanine green or methylene blue injection, and they lack comparative studies. This study will evaluate feasibility and surgical outcomes by comparing transvaginal paracervical and transperitoneal mapping in vNOTES hysterectomy with SLN procedure in endometrial cancer.

The study is an observational study with a prospective design. It will be implemented in a single institution, specifically 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.

According to inclusion and exclusion criteria, the patients will be randomized into two groups: the transvaginal paracervical lymphadenectomy group and the transperitoneal lymphadenectomy group.

Surgical Procedure of transvaginal paracervical sentinel lymphadenectomy group:

All patients(26) will receive V-NOTES with transvaginal paracervical sentinel lymph node (SLN) mapping followed by V-NOTES hysterectomy and bilateral salpingo-oophorectomy (BSO).

Transperitoneal sentinel lenfadenectomy group's Surgical Procedure:

All patients (26) will receive vNOTES hysterectomy with bilateral salpingo-oophorectomy (BSO) followed by transperitoneal vNOTES sentinel lymph node (SLN) mapping.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy

Procedure

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

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.

Primary outcomes

  1. Total operation duration

    Time frame: During surgery

    The total duration of the operation in minutes

  2. Duration of right and left lymphadenectomy

    Time frame: During surgery

    The duration of lymphadenectomies in minutes

  3. Number of lymph nodes excised

    Time frame: Postoperative second week

    Lymph node count in the pathology report

  4. number of positive lymph nodes

    Time frame: Postoperative second week

    Sentinel positive lymph nodes in the pathology report

  5. Hospitalization duration

    Time frame: During hospital stay

    Number of days patients stayed at the hospital postoperatively

  6. Total bleeding volume

    Time frame: During surgery

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

  7. Difference between pre- and postoperative hemoglobin values

    Time frame: Postoperative 1st day

    Hemoglobin level (g/dL)

  8. Surgical complications

    Time frame: During hospital stay

    Clavien dindo scale of surgical complications

  9. Location o SLN

    Time frame: During surgery

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

  10. Preoperative and postoperative hematocrit values

    Time frame: During hospital stay

    Hematocrit level (%)

  11. Tumor's patological features

    Time frame: Postoperative second week

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

  12. Management of complications

    Time frame: through study completion

    intraoperative and postoperative complication's management

  13. Duration of lateral colpotomy

    Time frame: During surgery

    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.

  14. Duration of hysterectomy

    Time frame: During surgery

    minutes

  15. Sentinel lymphnode's side and number

    Time frame: Postoperative second week

    number

Secondary outcomes

  1. Postoperative pain

    Time frame: 3rd and 6th month after operation

    visual analogue scale, higher scores indicate worse pain

  2. Sexual function

    Time frame: at postoperative 3rd and 6th month

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

  3. Timing of passing gas

    Time frame: During hospital stay

    Bowel function

  4. Demographic features

    Time frame: Postoperative second week

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

  5. Previous abdominal surgery

    Time frame: Preoperative day

    Medical history

  6. Initiation of mobilization

    Time frame: During hospital stay

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

  7. 6th hour and 24th hour VAS score

    Time frame: postoperatively 6th and 24th hours 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."

Study contacts

Contact information is provided by the study sponsor or research team.

Kevser Arkan, MD

CONTACT

[email protected]

+905536476838

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Acronym: ENDONOTE

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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