Randomized Study on Effects of Uniportal VATS Versus Triportal VATS for the Treatment of Stage I-II NSCLC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Measurement of postoperative pain after uni-portal and three-portal VATS
研究概览
简要总结
For the treatment of stage I-II NSCLC, two mini-invasive techniques are mostly utilized: uni-portal and three-portal VATS. In the uniportal approach, the injury on a single intercostal space could determine a lower level of pain than the three-portal approach, allowing a better postoperative course. Few studies in Literature compare these techniques, and most of them are retrospective.
The main purpose of this randomized study is to compare uni-portal VATS with three-portal VATS, in terms of postoperative pain.
Secondary objectives of the study are valutations of:
- respiratory and functional capacity between the two groups
- operative time
- number of resected lymphnodes
- intra and postoperative complications, such as conversions to open surgery, amount of bleeding, prolonged air leaks, surgical site infections, pulmonary complications.
详细描述
Randomized cohort clinical trial, prospectic, monocentric. Procedure of randomization: the day before the operation, with the "Random Allocation Rule" technique
Arm 1: pulmonary lobectomy and lymphoadenectomy with uni-portal VATS approach
Arm 2: pulmonary lobectomy and lymphoadenectomy with three-portal VATS approach
Misurations Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation.
The choice of cumulative analgesic consumption as parameter of primary outcome is because pain valuation with VAS is significantly affected by individual variability.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cT1-2N0-1M0 NSCLC, maximum diameter 5cm
- •ASA (American Society of Anestesiology) score 1-2-3
排除标准
- •N2-N3 disease
- •Induction chemotherapy
- •Thoracic wall infiltration
- •Previous thoracic surgery
- •Important pleural adhesions
- •Severe COPD, asthma, interstitial lung disease - Liver, kidney or cardiac failure
- •Clotting disorders
- •Analgesic allergy
- •Sublobar resection, sleeve lobectomy, pneumonectomy
- •Chronic analgesic, oppioids or cortisonic use
- •Absence of informed consent
结局指标
主要结局
Measurement of postoperative pain after uni-portal and three-portal VATS
时间窗: 7 days
Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation.
次要结局
- Measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery.(30 days)
- Valuation of respiratory function(30 days)
- Intraoperative parameters(1 day)
- Intraoperative bleeding(1 day)
- Postoperative air leakage(15 days)
- Postoperative complications(1 month)