Combined Application of 3D Printing Technology and Robotic Surgery in Radical Gastrectomy of Gastric Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- operation time
研究概览
简要总结
The incidence of gastric cancer is the highest in China, and surgery is one of the most effective treatment methods. Da Vinci robot radical gastrectomy for gastric cancer has the advantage of minimally invasive and fine operation. However, due to complicated perigastric anatomy, abundant blood supply and wide distribution of lymph nodes, it is widely used in clinical use of .Combine the 3D printing technique with imaging examination (digestive endoscopy,3Dct cta/ctv, etc.) ,making the 3D model of da Vinci robot assisted radical gastrectomy can fully show the anatomical relationship around gastric cancer, determine the flow and variation of splenic portal vessels, and the distribution of splenic hilar lymph nodes. In order to eliminate the imagination difference of spatial anatomical structure before operation, it is easier for surgeons to optimize the operation plan, to control the operation process and to improve the accuracy, and to adopt individualized operation suitable for the patients.
详细描述
The investigators will work with general surgery, imaging department and 3D printing center to try to print gastric cancer model and guide the operation. After obtaining the approval of the Hospital Ethics Committee, 20 patients with gastric cancer were collected for imaging examination and evaluation, and the normal physical model of 70% normal volume was printed with Guang Min resin material.The investigators will analyse the anatomical relationship between the tumor and surrounding tissues,and determine the range of tumor excision and the feasibility and safety of radical gastrectomy with Leonardo da Vinci robot for gastric cancer.Through the assistance of the 3D model,The investigators will select the suitable operation path to determine the extent of tumor excision and lymph node dissection.Furthermore, 3D print model is used to provide real-time navigation for key steps of surgery. The purpose of this research is to observe the application value of 3D printing technique in gastric cancer laparoscopic surgery with Leonardo da Vinci robot radical gastrectomy, and to provide reference for the development of 3D printing model of other complicated digestive tract surgery.
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
- 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;
- •Not found the tumor metastasis;
- •Normal coagulation function;
- •There is no history of anticoagulant drugs, or who take aspirin, salvia miltiorrhiza, etc., should stop taking drugs for more than one week;
- •Patients and their families volunteered choice the surgical procedure and 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
3D printing group
the radical gastrectomy for gastric cancer of Davinci robotic surgery with the assistance of 3D printing model
干预措施: 3D printing model (Procedure)
non 3D printing group
the radical gastrectomy for gastric cancer of Davinci robotic surgery without the assistance of 3D printing model
干预措施: non 3D printing model (Procedure)
结局指标
主要结局
operation time
时间窗: 1 hours to 6 hours through the surgery completion
record in minutes,from the beginning of anesthesia to the end
次要结局
- hospitalization expenses(1 month)
- blood loss(1 hours to 6 hours through the surgery completion)
- success rate(from two days to two weeks after surgery)
- time in bed(from two days to two weeks after surgery)
- postoperative complication rate(from two weeks to one year after surgery)
- tumor recurrence rate(from one month to 2 years after surgery)
- time to take food(from two days to two weeks after surgery)