Comprehensive Prospective Comparison Of Two Robotic Platforms In Anatomical Lung Resections: Clinical Outcomes And Cost-utility Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cost/utility ratio
研究概览
简要总结
The goal is to compare clinical outcomes, hospital costs, and cost-utility in patients undergoing anatomical lung resections with DaVinci Xi vs Versius platforms
The main questions it aims to answer are:
- Do patients that undergo an anatomical lung resection with DaVinci Xi have the same clinical outcomes (complications, stay...) than those who were operated with Versius?
- Are anatomical lung resections performed with DaVinci Xi more expensive than those performed with Versius?
- Are anatomical lung resection performed with DaVinci Xi more cost-effective than those performed with Versius?
Participants already undergoing robotic anatomical lung resection as part of their regular medical care will answer quality of life questionnaires preoperatively, at 1, 3, 6, and 12 months after surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that undergo segmentectomy or lobectomy with RATS.
排除标准
- •Conversion to VATS at the beginning of the procedure
研究组 & 干预措施
Da Vinci
Patients undergoing anatomical lung resection (ALR) with DaVinci Xi
干预措施: da Vinci Xi Surgical System (Device)
Versius
Patients undergoing anatomical lung resection (ALR) with Versius
干预措施: Versius Surgical System (Device)
结局指标
主要结局
Cost/utility ratio
时间窗: Data will be collected preoperatively (baseline), at 1, 3, 6, and 12 months after surgery.
The cost/utility ratio will be calculated as the incremental cost per quality-adjusted life year (QALY) gained, comparing robotic-assisted thoracic surgery (RATS) with Da Vinci Xi and Versius. Costs will include all direct procedural costs (including consumables, reusable instruments, operating room time, and maintenance costs of equipment), as well as postoperative hospital-related costs. Health outcomes will be expressed in QALYs, derived from validated health-related quality of life measures collected during follow-up. The analysis will be conducted from the healthcare system perspective, and results will be expressed as an incremental cost-effectiveness ratio (ICER).\*
次要结局
- Operation time(Perioperative/periprocedural)
- Conversions(Perioperative/periprocedural)
- Complications(Within 30 days after surgery)
- Lymph nodes yielded(Perioperative/periprocedural)
- Total cost(In-hospital (from the day of operation until the day of discharge))
研究者
Sara Fra Fernandez
Principal Investigator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal