Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- the operation time
研究概览
简要总结
The aim of this study is to compare the robotic-assisted laparoscopic surgery to the traditional laparoscopic surgery in endometrial cancer patients.
The study is prospective and the patients are randomised into two groups of 50 patients each. Randomisation is done with Minim-programme and patients age and Body mass index are taken into account.
The primary endpoint is the operation time. The number of patients in this study is based on the non-inferiority design. Presumption is that the operation time in robotic-assisted laparoscopy will be 25% longer.
Secondary endpoints include:
- bleeding
- complications
- conversions
- number of pelvic lymph nodes
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
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Endometrial cancer operations, which means hysterectomy, bilateral salphingo-oophorectomy and pelvic lymphadenectomy
- •Gr 1 and 2 differentiation type
排除标准
- •The operation cannot be made with an laparoscopy operation
- •Age more than 85 years or young under 30 years patient
研究组 & 干预措施
traditional laparoscopic surgery type
干预措施: Traditional surgery type (Procedure)
Robotic assisted operation type
干预措施: Robotic assisted laparoscopic surgery (Procedure)
结局指标
主要结局
the operation time
时间窗: From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours
次要结局
- bleeding(Duration of hospital stay, an expected average of 5 weeks)
- Number of participants with adverse events(Duration of hospital stay, an expected average of 5 weeks)
- Pain(Duration of hospital stay, an expected average of 5 weeks)
- pelvic lymph node volumes(Duration of hospital stay, an expected average of 5 weeks)
研究者
Minna Mäenpää
Principal Investigator
Tampere University Hospital