Cumulative Summation Analysis of Learning Curve for Robot-Assisted Gastrectomy in Gastric Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Operation time,min
研究概览
简要总结
The investigators prospectively collected the clinical data of Da Vinci robot-assisted radical gastrectomy patients conducted by the same group of physicians from October 2017 to October 2018. The learning curve of the surgery was analyzed with the moving average method and the cumulative sum analysis (CUSUM). The short-term efficacy was then validated by comparing the perioperative and pathologic outcomes of patients in the two stages of the learning curve.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Patients were 18-90 years old
- •Patients with a documented diagnosis of gastric adenocarcinoma
- •patients were scheduled to undergo minimally invasive gastric cancer surgery
- •4.patients with no preoperative evidence of serosal invasion or extraperigastric lymph node metastasis on preoperative computed tomography scans, upper endoscopy, and endoscopic ultrasound
排除标准
- •Patients with neoadjuvant treatment
- •Patients procedure concurrent with the gastrectomy
- •3.Patients with palliative surgery
- •Patients with the contraindications for general anesthesia
- •Patients were pregnant or mentally incompetent
- •Patients with serious systemic comorbidities, such as severe heart failure, respiratory failure, uncontrolled hypertension
结局指标
主要结局
Operation time,min
时间窗: 1 week
The surgeon begins the operation until the incision is closed
Docking time,min
时间窗: 1 week
From the skin cutting through the observation hole to the robot moving to the designated position, the lens and the instrument arm enter the abdominal cavity and prepare for this period
次要结局
- Number of retrieved lymph nodes(1 week)
- Day of first flatus,day(2 week)
- Day of first fluid diet,day(2 week)
- the rate of postoperative complications(30 days after the operation)
- postoperative hospital stay, days(30 days after the operation)
- cost(30 days after the operation)
- Evaluated blood loss ,ml(1 week)