Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of harvested lymph nodes
研究概览
简要总结
This study is intended to explore differences in oncologic and surgical safety between robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial cancer.
详细描述
Hypothesis
Robotic assisted laparoscopy (RAL)is equal in terms of oncologic and surgical safety as conventional abdominal surgery (AS) for high risk endometrial cancer (EC).
Methods: Women with high risk EC (defined as high grade endometrial, clear cell or serous) are randomized to either RAL or AS. Both groups will undergo complete surgical staging (hysterectomy, bilateral salpingoophorectomy, pelvic and paraaortal lymphadenectomy)
Primary endpoint: Number of harvested lymph nodes per station Secondary endpoints: Recurrences up to 3 year after surgery. Lymphatic side-effects, quality of life, cost, surgical morbidity.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-75 years of age
- •High risk endometrial cancer
排除标准
- •WHO performance>1
- •Severe comorbidity, ASA>3
- •Unable to understand information
研究组 & 干预措施
Robotic surgery
Experimental method, to be compared with standard care
干预措施: Robotic surgery (Procedure)
Abdominal surgery
Conventional open surgery (laparotomy)
干预措施: Abdominal surgery (Procedure)
结局指标
主要结局
Number of harvested lymph nodes
时间窗: 2 years
Extracted lymphatic tissue from 3 stations (above inferior mesenteric artery, below inferior mesenteric artery, pelvic) is analysed by a pathologist and the number of nodes for each station recorded and compared between the two groups
次要结局
- Lymphatic side-effects(2 years)
- Quality of life(2 years)
- Healthcare cost(2 years)
- Recurrence of cancer(3 years)
研究者
Henrik Falconer
MD, PhD
Karolinska Institutet