Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage Non-Small Cell Lung Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection
研究概览
简要总结
Robotic-assisted thoracoscopic surgery (RTS) is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC). During RTS, division, dissection, and sealing of lung tissue, bronchi, and blood vessels can be performed using handheld staplers with assistance from a bedside surgeon (Surgeon-Assisted), or totally robotically with robotic staplers and energy devices by the console surgeon (Totally Robotic). Totally Robotic lung resection enables the operating surgeon to perform the case independently, but its implication on costs and patient outcomes remains unknown. There also is, however, a lack of prospective research evaluating the costs of the two methods for dissection and vessel sealing in RTS. This RCT aims to evaluate the costs and perioperative patient outcomes of Totally Robotic lung resection using the Vessel Sealer Extend energy device (for vessels <7mm) and the SureForm robotic stapler (Intervention) versus Surgeon-Assisted robotic lung resection using the Signia stapler (Control) during RTS for NSCLC using the da Vinci system.
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
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 120 years at time of consent
- •Ability to speak and understand English
- •Clinical stage I, II or IIIa NSCLC
- •Candidate for RTS, as determined by the operating surgeon
排除标准
- •Anticoagulation with inability to cease anticoagulant therapy prior to surgery
- •Incurable coagulopathy
- •Systemic vascular disease or vasculitis
- •Not a candidate for RTS
研究组 & 干预措施
Surgeon-Assisted
Patients randomized to this arm will undergo RTS with the Medtronic Signia Stapler.
干预措施: Medtronic Signia Stapler (Device)
Totally Robotic
Patients randomized to this arm will undergo RTS with the Da Vinci Vessel Sealer Extend Energy Device and SureForm Stapler.
干预措施: Vessel Sealer Extend Energy Device and SureForm Stapler (Device)
结局指标
主要结局
Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection
时间窗: Up to 3 weeks following hospital discharge
Surgical device (stapler or energy) costs per surgery, along with inpatient hospitalization costs per day following surgery will be collected and evaluated in Canadian dollars.
次要结局
- Operating Room Time(3 weeks post-surgery)
- Length of Stay in Hospital(3 weeks post-surgery)
- Duration of Chest Tube(3 weeks post-surgery)
- Intraoperative Complications and Adverse events (AEs)(3 weeks post-surgery)
研究者
Wael Hanna
Division Head & Associate Professor, Division of Thoracic Surgery, McMaster University
St. Joseph's Healthcare Hamilton