Endometrial Cancer, Lymphadenectomy, Minimally Invasive Surgical Procedures, Natural Orifice Transluminal Endoscopic Surgery, Sentinel Lymph Node Biopsy
Conditions
Keywords
endometrial cancer, V-NOTES, lymphadenectomy, sentinel lymph node, transperitoneal, extraperitoneal
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREExtraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy
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).
PROCEDURETransperitoneal lymphadenectomy
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.
Sponsors
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of lateral colpotomy | 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. |
| Total bleeding volume | During surgery | Measured by the suction bottle's volume and number of surgical gauzse used during surgery |
| Difference between pre- and postoperative hemoglobin values | Postoperative 1st day | Hemoglobin level (g/dL) |
| Surgical complications | During hospital stay | Clavien dindo scale of surgical complications |
| Location o SLN | During surgery | The area that sentinel lymph node detected internal iliac, external iliac ,bifurcation or obturator fossa |
| Preoperative and postoperative hematocrit values | During hospital stay | Hematocrit level (%) |
| Tumor's patological features | Postoperative second week | Histophatology, grade, lymphovascular invasion, tumor diameter(cm), myometrial invasion, stage, total positive lymph node count |
| Management of complications | through study completion | intraoperative and postoperative complication's management |
| Duration of hysterectomy | During surgery | minutes |
| Sentinel lymphnode's side and number | Postoperative second week | number |
| Total operation duration | During surgery | The total duration of the operation in minutes |
| Duration of right and left lymphadenectomy | During surgery | The duration of lymphadenectomies in minutes |
| Number of lymph nodes excised | Postoperative second week | Lymph node count in the pathology report |
| number of positive lymph nodes | Postoperative second week | Sentinel positive lymph nodes in the pathology report |
| Hospitalization duration | During hospital stay | Number of days patients stayed at the hospital postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual function | at postoperative 3rd and 6th month | assessed by Female Sexual Function Index, higher scores indicate greater satisfaction |
| Timing of passing gas | During hospital stay | Bowel function |
| Demographic features | Postoperative second week | Age, gravidity, parity, previous vaginal delivery, body-mass index |
| Previous abdominal surgery | Preoperative day | Medical history |
| Initiation of mobilization | During hospital stay | After operation the time (hour) that paient is avaliable to mobilize out from the bed |
| 6th hour and 24th hour VAS score | 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. |
| Postoperative pain | 3rd and 6th month after operation | visual analogue scale, higher scores indicate worse pain |
Countries
Turkey (Türkiye)
Contacts
Primary ContactKevser Arkan, MD
Outcome results
None listed