Needlescopic-assisted Uniportal VATS Versus Conventional Uniportal VATS. A Randomized Prospective Noninferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Hospital stay
研究概览
简要总结
The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under assistance of needlescopic instruments through additional 2-3 mm ports compared to conventional uniportal VATS in patients with lung lesions.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lung or mediastinal disease requiring thoracoscopic surgery
排除标准
- •Thoracoscopic esophagectomy Decortication for empyema
结局指标
主要结局
Hospital stay
时间窗: 14 days
Post-operative hospital stay
Post-operative 3 month neuralgia
时间窗: 3 months
Out patient documented using PainDETECT questionnaire (PD-Q)
Pain scale POD 3
时间窗: 3 days
Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS)
Pain scale POD 5
时间窗: 5 days
Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS)
Post-operative 6 month neuralgia
时间窗: 6 months
Out patient documented using PainDETECT questionnaire (PD-Q)
次要结局
- Surgical bleeding(1 day)
- Cost(14 days)
- Opioid using dosage(14 days)
- Surgical time(1 day)
研究者
IRB of NTUH Hsin-Chu Branch
National Taiwan University Hospital Hsin-Chu Branch
National Taiwan University Hospital Hsin-Chu Branch