NCT06870903Recruiting
Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer
Source: ClinicalTrials.gov · Last updated 20 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 25 Feb 2025
- Start date
- 15 Mar 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Diseases
- Endometrial cancer
- NCT number
- NCT06870903
What you commit to
- Study type: Interventional
- Planned participants: 52
- From 15 Mar 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving neodajuvant therapy
Other illness
- Patients who have had previous malignancy surgery.
Other
- Contraindications to using methylene blue dye or contraindications to the vNOTES procedure.
- Severe, deeply penetrating endometriosis or enlarged uterus that may require forced vaginal extraction
Who the study is looking for
- 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.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 85 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gazi Yasargil Training And Research Hospital Coordinator of this site? Confirm its status | Diyarbakır | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.