STELLA 2 Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes, Evaluating Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Surgical complications
研究概览
简要总结
The purpose of this study is to determine whether or not there are more complications in the extraperitoneal compared with the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer
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 (Outcomes Assessor)
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
- •Diagnosis of endometrial cancer confirmed by histopathological analysis (endometrial biopsy) requiring surgical staging according to FIGO (the International Federation of Gynecology and Obstetrics) recommendations
- •Diagnosis of ovarian cancer confirmed by histopathological analysis after an initial cystectomy or oophorectomy without suspicion of neoplasia thus requiring additional surgical staging according to FIGO recommendations
排除标准
- •Diagnosis of advanced endometrial cancer based on findings on imaging techniques (CT, MRI and/or PET)
- •Diagnosis of advanced endometrial or ovarian cancer based on intraoperative findings (e.g. peritoneal carcinomatosis at initial laparoscopy)
- •Patients who underwent previous aortic lymphadenectomy
- •Patients who received previous pelvic and/or aortic radiotherapy
研究组 & 干预措施
Extraperitoneal
Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.
干预措施: Extraperitoneal Laparoscopic aortic lymphadenectomy (Procedure)
Transperitoneal
Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.
干预措施: Transperitoneal Laparoscopic aortic lymphadenectomy (Procedure)
结局指标
主要结局
Surgical complications
时间窗: intraoperatively, within 30 days after surgery, and past 30 days after surgery up to 3 months after surgery
Composite outcome defined by including at least one of the following: * Total estimated blood loss \> 500 mL during surgery * Blood transfusion * Intraoperative complication classified as Dindo grade III or worse, related to the aortic lymphadenectomy * Early postoperative complication (within 30 days after surgery) classified as Dindo grade III or worse, related to the aortic lymphadenectomy * Late postoperative complication (past 30 days after surgery) classified as Dindo grade III or worse, related to the aortic lymphadenectomy * Conversion to laparotomy during the aortic lymphadenectomy * Inability to complete the aortic lymphadenectomy
次要结局
- Overall survival(up to 3 years after surgery)
- Operative time(At the time of the surgery)
- Number of lymph nodes(Postoperatively (within 1 week), at the moment of histopathologic examination)
- Disease-free survival(up to 3 years after surgery)
- Hospital stay(Measured the day the patient is discharged (up to 100 days))