The Drainage Effect of a Chest Tube Plus Prophylactic Air-extraction Catheter vs Traditional Drainage Strategy in Uniportal Upper Lung Lobectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- pneumothorax incidence
研究概览
简要总结
Traditional drainage for uniportal video assisted thoracoscopic surgery (VATS) is a routine method, usually with one or two chest tubes at intercostal incisions, but postoperative pain due to the chest tube and unsatisfied drainage effect was noted.
In this study, the investigators are going to explore whether a prophylactic air-extraction catheter combined with chest tube drainage may not increase complications in uniportal VATS for upper lung lobectomy. The patients would be assigned to two arms, one with a prophylactic air-extraction catheter combined with chest tube, and another with two chest tubes, and the effect of the combined drainage strategy will be evaluated.
详细描述
Research purpose and background:
Surgical resection is still one of the most important treatment methods for early stage non-small cell lung cancer. Complete resection and reasonable dissection of mediastinal lymph nodes are the key of cancer cure. Lobectomy has always been the standard surgical method for lung cancer radical resection. It can remove the lesion and retain normal lung function by resecting the lung lobe where the lesion is and preserve the remaining lobe. In recent years, the development of uniport video-assisted thoracic surgery (VATS) has further reduced the trauma, with treatment benefit similar with that of two-port and three-port thoracoscopy. However, based on the single hole thoracoscopic lung recruitment, incision drainage and other issues also need further evidence support.
No tube technology, such as no tracheal intubation, drainage tube, nor catheter combined with video-assisted thoracoscopy, can significantly improve the rehabilitation of patients, and further shorten the postoperative hospital stay. In addition, the safety of tubeless drainage has been supported by more and more studies. However, poor drainage may also increase the incidence of pneumothorax and postoperative pulmonary dysfunction.
After upper lobe lobectomy, the cavity needs to be filled by the full recruitment of the remaining lobes. theoretically, there is a higher demand for the strategy of the drainage tube. The investigatorstried to compare the safety and effectiveness of the prophylactic air-extraction catheter (later known as microtubule) combined with thoracic tube drainage with traditional double drainage tube alone. Therefore, the investigators conducted a prospective, randomized, non inferiority trial to verify the hypothesis that microtubule combined with thoracic catheter drainage after uniport VATS upper lobectomy will not increase the related perioperative complications compared with traditional thoracic tube drainage.
Quality assurance plan:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data collected from the X-rays and the pain score evaluation will be masked and the outcomes assessor have no method to get randomized information.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing uniport VATS for left / right upper lobectomy in Shanghai Pulmonary Hospital
排除标准
- •preoperative presence of any unstable systemic disease, such as active infection, uncontrolled hypertension, or unstable angina pectoris;
- •previous ipsilateral thoracic surgery;
- •preoperative X-ray findings of pneumonia or atelectasis;
- •bleeding tendency;
- •anticoagulant use;
- •pregnancy or breastfeeding;
- •converted to open chest;
- •the patient underwent pneumonectomy or segmental resection or wedge resection;
- •severe adhesion occurred during the operation
结局指标
主要结局
pneumothorax incidence
时间窗: 24-30 hours after surgery
The incidence of pneumothorax on day 1 after operation
次要结局
- pain scores(1day, 3days and 30 days after surgery)
- Extubation time(within 30 days after surgery)
- Total volume(1 day after surgery)
研究者
Jiang Fan
Associate professor
Tongji University