The Impact of Chest Drain Type on Pain, Drainage Efficacy and Short Term Outcome Following VATS Lobectomy for Lung Cancer: A Prospective Randomized Study Comparing Silicone Versus PVC Drains
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Analgesics consumption
研究概览
简要总结
The goal of this prospective randomized clinical trial is to compare the impact of the chest tube type on pain, chest drainage efficacy and early postoperative outcome following VATS lobectomy for lung cancer.
The main questions it aims to answer are:
- silicone chest drains are less painful compared to standard PVC drains?
- is there any difference in chest drainage efficacy and short term outcome between the two groups? Researchers will compare silicone chest drain group with PVC chest drain group to see if there is any difference in postoperative pain, chest drainage efficacy and short term outcome.
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
- •primary lung cancer eligible for VATS lobectomy by tumor board meeting
排除标准
- •age under 18 years
- •high risk of post-operative complications (ASA > 3, diffusion capacity for transfer factor (TLCO) or forced expiratory volume at one second (FEV1) ≤ 40%, cycle ergometry with oxygen consumption (VO2 max) < 15 ml/kg/min)
- •tumors growing in parietal pleura
- •extended lung resection diffuse
- •previous surgery in the same hemithorax
- •chronic pain
- •chronic use of analgesics or sedatives
- •surgical revision
- •inability to participate in the study.
结局指标
主要结局
Analgesics consumption
时间窗: 2 days
Amount of analgesics used first two days after the surgery was analyzed and reported in milligrams. Higher scores mean a worse outcome.
Need for peroral analgesia after the chest tube removal
时间窗: 2 days
Need for peroral analgesia at first, second and fourth week after chest tube removal was assessed and reported as frequency in number. Higher scores mean a worse outcome.
Visual analogue scale
时间窗: 2 days
Post-operative pain during the first two days after the surgery was analyzed by using the visual analogue scale (VAS). Scale tittle was Visual Analogue Scale. Minimum value on a scale was 0 and maximum value was 10. Higher scores mean a worse outcome.
Maximal expiratory pressure
时间窗: 2 days
Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal expiratory pressure (MEP) in cmH2O. Higher scores mean a better outcome.
Maximal inspiratory pressure
时间窗: 2 days
Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal inspiratory pressure (MIP) in cmH2O. Higher scores mean a better outcome.
次要结局
- Reintervention rate(1 month)
- Respiratory complication rate(1 month)
- Duration of chest drainage(1 month)
- Pneumothorax rate on the day of surgery(First day)
- Pneumothorax rate after chest tube removal(1 month)
- Pleural effusion rate on the day of surgery(First day)
- Readmission rate(1 month)
- Pleural effusion rate after chest tube removal(1 month)
- Duration of hospital stay(1 month)
- Subcutaneous emphysema rate(1 month)
- Prolonged air leak rate(1 month)
研究者
Boris Greif, MD
Head of Thoracic Surgery
University Medical Centre Ljubljana