Thoracoscopic Surgery Without Chest Tube Placement in Patients With Peripheral Lung Nodules: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Postoperative hospital stay
研究概览
简要总结
Chest tube placement after thoracoscopy surgery had been generally accepted as routine procedure for removal of the residual intrapleural fluid and air, however, it would cause post-operative pain, prohibit ambulation after surgery, and prolong the hospital stay. According to the recent studies, omission of chest tube placement after minor thoracoscopic procedures (such as pulmonary wedge resection) had been safe and feasible, and it also reduced the post-operative pain and shortened the hospital stay. We will conduct a prospective randomized trial in National Taiwan University Hospital.
详细描述
We will enroll 100 patients with peripheral lung nodule who will be randomly assigned to no chest tube placement (tubeless group) or chest tube placement (control group) after thoracoscopic wedge resection with out without lymph adenectomy. The primary endpoints are to compare the post-operative hospital stay and post-operative pain sale between the two groups. The secondary endpoints are to compare the intercostal neuralgia and wound satisfaction one month after surgery between the two groups.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CT revealed peripheral lung nodule, with both size and depth less than 2 cm
- •Aged 20 to 80 years
排除标准
- •Patients with ventilatory defect
- •Previous ipsilateral thoracic surgery
- •Bleeding tendency or anticoagulant use
- •Comorbidity including congestive heart failure, liver cirrhosis, chronic renal disease
- •Pregnancy or breast feeding
- •Immunocompromised or long-term steroid use
- •Severe infected patient
- •Patient who can not sign permit
结局指标
主要结局
Postoperative hospital stay
时间窗: 1 week
次要结局
- Postoperative pain score(1 week)
- Postoperative intercostal neuralgia(1 month)
- Postoperative wound satisfaction(1 month)