A Randomized Controlled Study: the Effect of Multiple-portal VATS Versus Conventional VATS Lobectomy for NSCLC
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- short-term quality of life(EQ5D) between the two groups
研究概览
简要总结
This study evaluate multiple-portal VATS and uniportal VATS lobectomy for NSCLC, half of participants will receive multiple VATS, while the other half will receive uniportal VATS lobectomy.
详细描述
Conventional VATS and uniportal VATS lobectomy can be performed each for NSCLC. Conventional VATS lobectomy employ 3 or 4 ports for completing the operation. Usually the camera port is performed at the seventh or eighth intercostals space within the trocar, so it's easy to cause the intercostals nerve and vessel injure, and still create obvious pain.
However, the lobectomy for lung cancer can be accomplished with a single incision. According to the initial results, Uniportal VATS (UVATS) lobectomy procedure has been wide adopted by less acess trauma, relieve postoperative pain. But these were retrospective and descriptive, not randomized study. Further randomized control studies will be required to demonstrate that there are more benefits in UVATS techniques compared with conventional VATS for lobectomy.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical diagnosis of primary lung cancer with the age between 35 and 75 years old;
- •Patients with Tumor size ≤5cm，clinically staged T1-2N0-1M0，prepared for lobectomy and mediastinal lymph node dissection;
- •Patients with an American Society of Anesthesiology score of 0-1.
排除标准
- •Patients with N2 or N3 positive or distant metastasis.
- •Patients who had undergone Neoadjuvant chemotherapy.
- •Patients with tumor invasion to the peripheral structures.
- •Patients with previous history of thoracic operations.
- •Patients with serious thoracic adhesion.
- •Patients who will undergo Pneumonectomy, sleeve lobectomy, segmentectomy, wedge resection.
- •Patients with preexisting chronic obstructive pulmonarydisease, asthma, or interstitial lung disease;
- •Patients with cardiac, hepatic, or renal dysfunction;
结局指标
主要结局
short-term quality of life(EQ5D) between the two groups
时间窗: Up to 6 month
To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, hospital stay and so on) between two groups.
次要结局
- lung function(pre-operative, 3 weeks, 3 months after surgery)
- Pain Scores after surgery(1, 3 days and 1, 3 months after surgery)
- intra-operative and postoperative complications(form the day of surgery up to discharege (expected within 1 month))
- The surgeon's ergonomic influence during operation(blinks/min)(The video is capture every 5 minutes and lasted for 1 minute)
研究者
Junqiang Fan
Thoracic Surgery Department
Second Affiliated Hospital, School of Medicine, Zhejiang University