Pain and Reasons for Hospitalization in Patients Treated Without Post-operative Chest Tube After Thoracoscopic Wedge Resection - A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
Chest tubes are used routinely although preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal. Previous studies are however either retrospective or mainly concerning benign disease.
Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, better pulmonary function and similar complication profile 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
- Double (Participant, Care Provider)
盲法说明
Randomization occurs after ended surgery, thus masking allocation to the personnel and participant. After Randomization, there is no masking.
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
- •Elective thoracoscopic wedge resection
- •Speaks and understands Danish
- •FEV1 >= 60% of expected
排除标准
- •Increased risk of air leak evaluated by surgeon (large adhesions, bullae, emphysema, deep resection, etc.)
- •Increased risk of bleeding evaluated by surgeon (high INR, anticoagulation not paused, large bleeding, etc.)
- •Air leak on intraoperative sealing test
- •Patients previously included in study
- •Planned intraoperative frozen section with possible lobectomy
- •Previously included in current study
- •Planned frozen section diagnostics
- •Previous ipsilateral anatomic lung resection
研究组 & 干预措施
Chest tube group
Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard post-operative chest tube.
干预措施: Intraoperative sealing test (Procedure)
Chest tube group
Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard post-operative chest tube.
干预措施: Standard post-operative chest tube (Procedure)
No chest tube group
Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.
干预措施: Intraoperative sealing test (Procedure)
No chest tube group
Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.
干预措施: Intraoperative chest tube removal (Procedure)
结局指标
主要结局
Pain
时间窗: Through post-operative admission, an average of 1 day.
Average pain expressed as area under the curve from a numeric rank score at 1, 3, 6 and 9 hours after surgery as well as daily at 8 am and 8 pm from post-operative day 1 until discharge.
Pain on NRS
时间窗: Through post-operative admission, an average of 1 day.
Differences in pain between the two groups.
次要结局
- Reasons for post-operative admission(Through post-operative admission, an average of 1 day.)
- Pneumothorax(Up to post-operative day 1.)
- Lung function(Up to post-operative day 1.)
- Reinsertion of chest tubes(Up to post-operative day 30.)
- Complications(Up to post-operative day 30.)
研究者
Bo Laksáfoss Holbek
Medical doctor
Rigshospitalet, Denmark