Uniportal Video Assisted Thoracoscopic Surgery (VATS) Debridement Versus Chest Tube Drainage in Early Stage Empyema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
This randomized controlled study compared uniportal video-assisted thoracoscopic surgery (U-VATS) versus chest tube drainage for initial (first-line) treatment of stage I (exudative) and stage II (fibrinopurulent) empyema in adult patients (>18 years old). The primary end-point of outcome was the overall success of treatment (no need for re-intervention or death). The main results demonstrated the safety of minimally invasive U-VATS procedure in the initial treatment of early stages of pleural empyema in comparison to traditional chest tube drainage. Initial use of U-VATS was safe and feasible due to postoperative freedom from complex or marked effusion, in addition to significant reduction in the need for additional intervention, postoperative complications, length of hospital stay, and total cost.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed to have empyema and indicated for surgery.
- •Age above 18 years old
排除标准
- •Inability to tolerate single lung ventilation.
- •Contraindication for general anesthesia/ medically unfit
研究组 & 干预措施
2
- This group included 30 adult patients with stage I/II pleural empyema who underwent conventional tube thoracotomy.
- All patients were subjected to the following:
1. Full history taking. 2.Full clinical examination. 3-Routine Laboratory investigations and Pleural fluid sample analysis. 4- Radiological investigations: Chest X-ray , CT chest.
- The patient is placed in a supine position.
- The intercostals pace is opened .
- Chest tube is inserted in proper position regarding the site of fluid collection.
干预措施: Tube thoracostomy (Procedure)
1
- This group included 30 adult patients with stage I/II pleural empyema who operated initially by VATS.
- All patients were subjected to the following:
1. Full history taking. 2.Full clinical examination. 3-Routine Laboratory investigations and Pleural fluid sample analysis. 4- Radiological investigations: Chest X-ray , CT chest.
- All patients will be managed by general anesthesia using double lumen endoteracheal tube to achieve single lung ventilation.
- All patients were positioned in lateral decubitus position.
- Single port skin incisions was made to pass the port through which the camera head and instruments were introduced into the chest .
- One chest tubes ws inserted as drains.
干预措施: Uniportal VATS (Procedure)
结局指标
主要结局
Mortality
时间窗: 6 months after inital treatment
Postoperative in-hospital or follow-up death.
Need for further management
时间窗: 6 months after inital treatment
Need for further method for pleural fluid drainage or decortication.
次要结局
未报告次要终点
研究者
Yasser Ali Kamal
Clinical professor
Minia University