Efficacy of Avoiding Chest Drain After Video-assisted Thoracoscopic Surgery Wedge Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 4
- 主要终点
- Acute Pain
研究概览
简要总结
Chest drain is used routinely after lung surgery. Despite preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal, these are either retrospective or mainly concerning benign disease.
Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, reduced opioid usage without increasing postoperative complications than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.
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
- •Age ≥18 years.
- •Patients referred for elective three port video-assisted thoracoscopic surgery wedge resection of the lung for suspected or confirmed malignant nodules.
- •first second forced expiratory volume ≥60% of expected.
- •No increased bleeding risk (e.g. preoperative international normalized ratio >2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy).
- •Not scheduled for frozen section pathology of wedge resection and subsequent lobectomy.
- •Able and willing to give informed consent.
排除标准
- •Increased risk of post-operative air leak assessed perioperatively by the surgeon (e.g. severe adhesions, bullous/emphysematous lung tissue, defects of the visceral pleura due to iatrogenic or other reasons, suturing in the lung tissue, deep lung resection).
- •Increased risk of post-operative bleeding assessed perioperatively by the surgeon (e.g. intraoperative bleeding or oozing).
- •Air leak during intraoperative air leak test.
结局指标
主要结局
Acute Pain
时间窗: Up to postoperative day 1
Postoperative pain assessed in three different situations (at rest, arms lifted and during cough) by questionnaire at 3 and 6 hours after surgery, and on the morning of postoperative day 1 at 8 a.m
Rescue analgesics
时间窗: Up to postoperative day 1
The amount of rescue analgesics given assessed as cumulative amount of morphine during the first 24 hours after surgery milligram equivalents (MME) as defined by pro.medicine.dk hosted by the Danish Association of the Pharmaceutical Industry
次要结局
- Time to fulfilled discharge criteria(Through post-operative discharge, an average of 2 days)
- Pneumothorax(Up to postoperative 2 weeks)
- Complications(Up to postoperative day 30)
- Quality of recovery after surgery(Up to postoperative day 1)
- Standard analgesics given(Up to postoperative 2 weeks)
- Persistent pain(Up to postoperative day 6)
- Length of stay(Through post-operative discharge, an average of 2 days)
- Readmission(Through post-operative admission, an average of 7 days)
- Chest drain reinsertion(Up to postoperative day 30)
研究者
Lin Huang
Department of cardiothoracic surgery
Rigshospitalet, Denmark