Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Total operation duration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
transvaginal paracervical sentinel lymphadenectomy group
Surgical Procedure of transvaginal sentinel lymphadenectomy group:
All patients will be operated in accordance with Memorial Sloan Kettering Cancer Center procedure. V-NOTES will consist of transvaginal paracervical sentinel lymph node (SLN) mapping followed by V-NOTES hysterectomy and bilateral salpingo-oophorectomy (BSO).
SLN Mapping:
Under general anesthesia, subjects will be placed in supine lithotomy position. Methylene blue solution (BLUMET IV INJECTION INJECTABLE 50 mg/5 ml 1x5 ml) (1 mL submucosal to the cervix at the 3 and 9 o'clock positions and 1 mL at a depth of 1-2 cm, using a total volume of 2-4 mL.
Monitoring of lymphatic ducts includes identification of structures stained with methylene blue dye in the expected anatomical location, typically between the internal and external iliac veins or in the obturator region. Bilateral and symmetrical structures believed to be sentinel lymph nodes (SLNs) will be removed. When unilate
干预措施: Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy (Procedure)
Transperitoneal lymphadenectomy
In this arm, patients will undergo transperitoneal lymphadenectomy with V-NOTES. The procedure begins with methylene blue injection for sentinel lymph nodes. Methylene blue will be injected at the 3 and 9 o'clock positions on the cervix, first at a depth of 1 mm and then at 4 mm, with 1 cc administered at each point. This will result in a total of 4 cc (1 cc x 4). Then, the procedure will continue 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.
干预措施: Transperitoneal lymphadenectomy (Procedure)
结局指标
主要结局
Total operation duration
时间窗: During surgery
The total duration of the operation in minutes
Duration of right and left lymphadenectomy
时间窗: During surgery
The duration of lymphadenectomies in minutes
Number of lymph nodes excised
时间窗: Postoperative second week
Lymph node count in the pathology report
number of positive lymph nodes
时间窗: Postoperative second week
Sentinel positive lymph nodes in the pathology report
Hospitalization duration
时间窗: During hospital stay
Number of days patients stayed at the hospital postoperatively
Total bleeding volume
时间窗: During surgery
Measured by the suction bottle's volume and number of surgical gauzse used during surgery
Difference between pre- and postoperative hemoglobin values
时间窗: Postoperative 1st day
Hemoglobin level (g/dL)
Surgical complications
时间窗: During hospital stay
Clavien dindo scale of surgical complications
Location o SLN
时间窗: During surgery
The area that sentinel lymph node detected internal iliac, external iliac ,bifurcation or obturator fossa
Preoperative and postoperative hematocrit values
时间窗: During hospital stay
Hematocrit level (%)
Management of complications
时间窗: through study completion
intraoperative and postoperative complication's management
Tumor's patological features
时间窗: Postoperative second week
Histophatology, grade, lymphovascular invasion, tumor diameter(cm), myometrial invasion, stage, total positive lymph node count
Duration of lateral colpotomy
时间窗: 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.
Duration of hysterectomy
时间窗: During surgery
minutes
Sentinel lymphnode's side and number
时间窗: Postoperative second week
number
次要结局
- Postoperative pain(3rd and 6th month after operation)
- Sexual function(at postoperative 3rd and 6th month)
- Timing of passing gas(During hospital stay)
- Demographic features(Postoperative second week)
- Previous abdominal surgery(Preoperative day)
- Initiation of mobilization(During hospital stay)
- 6th hour and 24th hour VAS score(postoperatively 6th and 24th hours score)
研究者
Sedat Akgöl
Head of Gynecology Oncology Department
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital