The Feasibility of Assessing Economic Costs of the Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy for Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Feasibility and safety
研究概览
简要总结
Robotic-assisted thoracoscopic surgery (RTS) segmentectomy is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC). In RTS-segmentectomy, dissection and sealing procedures are performed by either staplers or energy devices.
Staplers, the current standard of care, have been associated with higher operating costs compared to energy devices for open lobectomy, RTS lobectomy and minimally invasive segmentectomy. However, there is a lack of prospective research evaluating the costs of the two methods for lung dissection and vessel sealing in RTS-segmentectomy.
This prospective trial seeks to determine whether it is feasible to conduct a randomized controlled trial evaluating the costs of the Signia stapler versus Vessel Sealer Extend energy device in RTS-segmentectomy for NSCLC. If this trial is feasible, we will be able to conduct a full-scale trial to compare costs and health outcomes, providing an economic evaluation that will inform hospital decision makers and clinicians in Canada.
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 segmentectomy, 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 segmentectomy
研究组 & 干预措施
Medtronic Signia Stapler
Patients randomized to this arm will undergo RTS segmentectomy with the Medtronic Signia Stapler.
干预措施: Medtronic Signia Stapler (Device)
Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling
Patients randomized to this arm will undergo RTS segmentectomy with the Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling.
干预措施: Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling (Drug)
结局指标
主要结局
Feasibility and safety
时间窗: Up to 3 weeks post-surgery
No adverse impacts of the study procedures on participants
Data collection of stapler quantities
时间窗: Up to 3 weeks post-surgery
Ability to collect the number of stapler reloads used
Data collection of energy sealing data
时间窗: Up to 3 weeks post-surgery
Ability to collect the sealing time in seconds
Recruitment
时间窗: Up to 8 weeks after recruitment first opens
Recruitment rate of at least 70%
Randomization
时间窗: Baseline
Ability to randomize patients to one of two groups
Data collection of stapler reload model
时间窗: Up to 3 weeks post-surgery
Ability to collect the type of stapler reloads used
Data collection of energy device data
时间窗: Up to 3 weeks post-surgery
Ability to collect the generator setting of the energy device
次要结局
- Adverse events (AEs) and complications(3 weeks post-surgery)
- Intraoperative costs of stapler or energy device use(Up to 3 weeks following hospital discharge)
- Hospitalization costs based on length of hospital stay(From admission to discharge, up to 14 days)
研究者
Wael Hanna
Division Head & Associate Professor, Division of Thoracic Surgery, McMaster University
St. Joseph's Healthcare Hamilton