Comparison of Robot Assisted Thoracic Surgery With Video Assisted Thoracic Surgery in Case of Lung Cancer: a Prospective Trial With Control Group
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
In this study the investigator will compare the effectiveness of robot assisted thoracic surgery (RATS) with video assisted thoracic surgery (VATS) in case of lung cancer.
The perioperative circumstances and postoperative outcome will be compared.
详细描述
Participants are randomly subdivided (1:1) to either undergo robot assisted lobectomy or video assisted thoracoscopic lobectomy in case of lung cancer. At the end of both surgical interventions the anaesthesiologist administers the same technique of pain relief: paravertebral blockage.
The data that are going to be investigated are: operative time, conversion to spreading of the ribs/thoracotomy, blood loss, lymph node dissection, prolonged air leak, chest tube drainage, length of stay, inflammatory reaction (through inflammatory parameters CRP, IL-3, IL-6, TNF), lung recuperation (through a lung function test) and postoperative pain (VAS score questionnaire).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients must be 18 years old or older
- •Patients can be male or female
- •Patients with a lung tumour which is treatable with surgery
排除标准
- •Pregnancy
- •Inoperable lung tumour
- •Patients which are at risk for general anaesthesia
研究组 & 干预措施
Robot assisted thoracic surgery
RATS
干预措施: Video assited thoracic surgery (Procedure)
Video assisted thoracic surgery
VATS
干预措施: Robot assited thoracic surgery (Procedure)
结局指标
主要结局
Postoperative pain
时间窗: 2 months
0 = no pain 10 = unbearable pain: VASscore
次要结局
- conversion to spreading of the ribs/thoracotomy(up to 4 hours)
- prolonged air leak(up to 7 days)
- chest tube drainage(up to 7 days)
- blood loss(up to 4 hours)
- Inflammatory reaction(48 hours)
- operative time(up to 4 hours)
- length of stay(up to 7 days)
- pulmonary function(2 months)
- lymph node dissection(up to 4 hours)
研究者
Veerle Van Mossevelde
data nurse
Universitair Ziekenhuis Brussel