Accelerated Learning Curve in Low Anterior Resection for Rectal Resection, a New Surgical Robot Micro Hand S Versus da Vinci, Can be Attained Simultaneously: a Single Center Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- learning curve of console time
研究概览
简要总结
Central South University in collaboration with Tianjin University developed the first domestically produced Chinese minimally invasive surgical (MIS) robot system which named "Micro Hand S" in 2013. This new MIS robot had been authorized to enter the clinical trial stage by the Ethics Committee of the Third Xiangya Hospital at Central South University. The Micro Hand S robot is safe and feasible in the preliminary study. However, the learning curve in low anterior resection for rectal resection with the Micro Hand S robot are unclear and whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously. Therefore, the investigators conduct this retrospective study to focus on this concern.
详细描述
The Micro Hand S robor has been appiled in low anterior resection for rectal cancer. The safey and feasibility has been evaluated. However, the learning curve of this procedure is unclear. Specially,whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously are unclear.Therefore, this srudy is conducted to evaluate the learning curve of the two robots in low anterior resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed rectal cancer; ASA score ≤ 3
排除标准
- •palliative resections, combined resections, distant metastasis, a previous history of abdominal/or pelvic surgery
研究组 & 干预措施
Surgeon A
This group is consisted of 56 cases performed using the Micro Hand S robot and da Vinci robot by one single surgeon in low anterior resection for rectal cancer
干预措施: Micro Hand S robot and da Vinci robot (Device)
Surgeon B
This group is consisted of 56 cases performed using the da Vinci robot by one single surgeon in low anterior resection for rectal cancer
干预措施: da Vinci robot (Device)
结局指标
主要结局
learning curve of console time
时间窗: up to 1 week after operation
It was defined the cumulative sum plot of the consloe time in the chronological order.
learning curve of docking time
时间窗: up to 1 week after operation
It was defined the cumulative sum plot of the docking time in the chronological order.
learning curve of surgicla failure
时间窗: up to 1 week after operation
It was defined the cumulative sum plot of the docking time in the chronological order.
次要结局
- Docking time (min)(up to 1 week after operation)
- Operative time (min)(up to 1 week after operation)
- Console time (min)(up to 1 week after operation)
- Conversion(up to 1 week after operation)
- Hospital stay (day)(up to 1 month after operation)
- Surgical failure(up to 1 month after operation)
- Type of surgical procedure(up to 1 week after operation)
- Bloos loss (ml)(up to 1 week after operation)
- Retrieved lymph node(up to 1 month after operation)
- Protective ileostomy(up to 1 month after operation)
- Length of distal ressction margin (cm)(up to 1 month after operation)
- pTNM stage(up to 1 month after operation)
- Tumor size (cm)(up to 1 month after operation)
- Local recurrence(at least 1 years after operation)
- Disease free survival(at least 1 years after operation)
- Status of the surgical margin(up to 1 month after operation)
- Postoperative complication(up to 1 month after operation)
- Quality of specimen(up to 1 month after operation)