Safety and Feasibility of the Application of Thoracic Puncture Tube VS Combination of Puncture Tube and Silicone Tube After Uniportal VATS Pulmonary Lobectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of postoperative complications
研究概览
简要总结
There have been several reports on the feasibility of a no-drain policy after pneumonectomy, but the policy is not widely accepted because silent massive hemorrhage, delayed air leaks, and chylothorax would always be major worries for thoracic surgeons, and all of the researches were retrospective case studies with small sample size and insufficient evidence. Therefore, the purpose of this study is to to evaluate safety and feasibility of an improved policy, the application of a small thoracic puncture tube after pulmonary lobectomy.
详细描述
This study will be accepted in patients with uniportal VATS(Video-assisted Thoracoscopic Surgery）lobetomy. A randomized controlled study protocol will be used, and The patients will be devided into two groups: experimental group for the application of a small thoracic puncture tube and control group for the application of Combination of the puncture tube and traditional silicone tube. The intraoperative conditions, postoperative recovery and the incidence of perioperative complications will be compared. The safety and feasibility of the application of the small thoracic puncture tube after pulmonary lobectomy will be evaluated.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age and gender: 18-70 years old, male and female unlimited;
- •Cardiopulmonary function can tolerate operation;
- •Primary non-small cell lung cancer was diagnosed by preoperative or intraoperative pathology. The surgical ranges are uni-portal VATS lobectomy with or without mediastinal lymph node dissection or sampling. In cases with multiple nodules in other lobes of the same side, small wedge resections are allowed;
- •No air leakage was observed intraoperatively. Meanwhile, after operation, there are also no air leakage observed in water seal bottle when patients are changed from lateral decubitus to horizontal position.
- •Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent..
排除标准
- •Patients with a severe emphysema or pulmonary bullae;
- •Patients with a history of chemotherapy or chemo-radiotherapy;
- •Patients with a history of chest surgery;
- •Extensive thoracic adhesion ;
- •A history of serious mental illness;
- •Patients with other conditions considered by the researcher should not participate in the study.
结局指标
主要结局
Incidence of postoperative complications
时间窗: within 30 days after surgery
The incidence of complications within 30 days after surgery in each arm
次要结局
- Incidence of subcutaneous emphysema after operation(within 30 days after surgery)
- Incidence of postoperative pneumothorax(within 30 days after surgery)