An Analysis of Costs and Outcomes Based on the Open, Laparoscopic, and Da Vinci Robotic Approach for Gastric Cancer Resection.
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Tumor recurrence rate
研究概览
简要总结
Gastric cancer is a common gastrointestinal tumor, and surgical operation is still the main method of gastric cancer treatment. Reported for the first time since 1994, the laparoscopic gastric cancer radical prostatectomy, laparoscopic technique is widely applied in the field of gastrointestinal surgery, has gradually replaced the traditional open operation as the main mode of surgical treatment for gastric cancer. Although laparoscopy has many advantages, there are still disadvantages, such as the discomfort of the physician, the reverse operation, and the ease of shaking, which hinder the application of laparoscopy. In recent years, the Da Vinci robot assisted gastric resection has become a new way to treat gastric cancer. Compared with the traditional laparoscopy and laparotomy, the operation of the robot is more precise and flexible, with obvious advantages of minimally invasive and good application value and prospect. The aim of the study is to compare value (outcomes/costs) of surgery in patients with Gastric Cancer by 3 approaches: open, laparoscopic, and robotic.First of all, the investigators will collect 500 cases of Gastric Cancer patients, randomly assigned for the open, laparoscopic, and robotic group. Secondly, to analyzing the demographic data,basic treatment and follow-up data, including the operation time, blood loss, the number of cut edge positive, the distances of cut edge away from the tumor edge, the cases of anastomotic fistula bleeding, stenosis, average such confinement, the meal time, cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and frequency, reflux esophagitis, bile reflux gastritis and other indicators.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients without contraindications gastroscope,surgery and anesthesia;
- •There is no history of abdominal surgery, no severe abdominal cavity adhesion
- •Patients signed informed consent
排除标准
- •Patients with preoperative assessment of distant metastasis;
- •Patients with preoperative radiation and chemotherapy or hormone therapy;
- •Patients with acute obstruction, bleeding or perforation of the emergency surgery
- •Patients with a history of abdominal trauma or abdominal surgery.
- •Patients with contraindications gastroscope,surgery and anesthesia;
研究组 & 干预措施
Open
干预措施: laparotomy (Procedure)
Laparoscopic
干预措施: Laparoscopic (Procedure)
Robotic
干预措施: Robotic (Procedure)
结局指标
主要结局
Tumor recurrence rate
时间窗: 2 years
cost of treatment
时间窗: 2 years
次要结局
- the operation time(one hour-six hours)
