Prospective Randomized Comparative Evaluation of Different Chest Drainage Devices in Patients Undergoing Lung Lobectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative Pneumothorax (PNX)
研究概览
简要总结
This randomized clinical trial compared two different chest drain sizes, 20 Fr and 24 Fr, in patients undergoing lung lobectomy for lung cancer. The study aimed to determine whether the size of the chest drain affects postoperative recovery. Outcomes included the presence of pneumothorax and pleural effusion, postoperative pain, subcutaneous emphysema, prolonged air leak, duration of chest drainage, and length of hospital stay. A total of 80 patients were randomly assigned in a 1:1 ratio to receive either a 20-Fr or a 24-Fr chest drain.
详细描述
Chest drainage is routinely used after pulmonary lobectomy to evacuate air and fluid from the pleural cavity and promote lung re-expansion. However, the optimal chest drain size after minimally invasive lung surgery remains uncertain. Smaller chest drains may improve patient comfort and reduce postoperative pain, but their ability to provide adequate pleural drainage compared with larger drains requires evaluation.
This single-center, prospective, randomized interventional study compared 20-Fr and 24-Fr chest drains in patients undergoing uniportal video-assisted thoracoscopic (uVATS) lung lobectomy with systematic mediastinal lymphadenectomy for non-small cell lung cancer (NSCLC). Eligible patients were randomly assigned in a 1:1 ratio to receive either a 20-Fr or a 24-Fr thoracic drain at the end of surgery.
Postoperative assessment included radiographic evaluation for pneumothorax and residual pleural effusion, as well as evaluation of subcutaneous emphysema, prolonged air leak, analgesic use, postoperative pain using the Numerical Rating Scale, chest drain duration, and length of hospital stay. The study was designed to evaluate whether chest drain size influences postoperative clinical outcomes and patient comfort following minimally invasive pulmonary lobectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing pulmonary lobectomy with systematic mediastinal lymphadenectomy for lung cancer using a uniportal video-assisted thoracoscopic approach.
- •FEV1/FVC >70%.
- •Clinical stage up to and including stage IIB according to the eighth or ninth edition of the TNM classification.
- •No morphological evidence of macrobullous emphysema on computed tomography.
排除标准
- •Neoadjuvant chemoradiotherapy.
- •Previous ipsilateral pulmonary resection.
- •FEV1/FVC <70%.
- •Clinical stage beyond IIB according to the eighth or ninth edition of the TNM classification.
- •Macrobullous emphysema on computed tomography.
- •pregnant and breastfeeding women
研究组 & 干预措施
20-Fr Chest Drain
Patients undergoing uniportal video-assisted thoracoscopic lobectomy with systematic mediastinal lymphadenectomy received a 20-Fr thoracic drain at the end of surgery.
干预措施: 20-Fr Thoracic Drain (Device)
24-Fr Chest Drain
Patients undergoing uniportal video-assisted thoracoscopic lobectomy with systematic mediastinal lymphadenectomy received a 24-Fr thoracic drain at the end of surgery.
干预措施: 24-Fr Thoracic Drain (Device)
结局指标
主要结局
Postoperative Pneumothorax (PNX)
时间窗: Immediate postoperative period (POD0), postoperative day 1 (POD1), and postoperative day 3 (POD3)
Presence of postoperative PNX assessed by chest X-Ray.
Postoperative Pleural Effusion
时间窗: Immediate postoperative period (POD0), postoperative day 1 (POD1), and postoperative day 3 (POD3)
Presence of residual postoperative pleural effusion assessed by chest X-Ray
次要结局
- Postoperative Subcutaneous Emphysema(During postoperative hospitalization)
- Postoperative Analgesic Use(Immediately after surgery to hospital discharge)
- Prolonged Air Leak(From surgery through chest drain removal, with prolonged air leak defined as lasting more than 5 postoperative days, assessed up to 30 days after surgery)
- Chest Drain Duration(Immediately after surgery to chest drain removal, assessed up to 30 days after surgery)
- Length of Hospital Stay(Immediate after surgery to hospital discharge, assessed up to 30 days after surgery)
- Postoperative Pain(12, 24, and 48 hours after surgery)