About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Anticoagulation with inability to cease anticoagulant therapy prior to surgery
Incurable coagulopathy
Systemic vascular disease or vasculitis
Not a candidate for RTS
Trial design
Parallel
Treatments tested in this trial
Medtronic Signia Stapler
DeviceThe Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery.
Vessel Sealer Extend Energy Device and SureForm Stapler
DeviceThe Vessel Sealer Extend Energy Device is integrated with the da Vinci system and uses bipolar energy technology to facilitate tissue dissection and vessel sealing.
Treatment groups
Trial outcomes
Primary outcomes
Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection
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.
Secondary outcomes
Operating Room Time
Entry into Operating Room to Exit, in minutes
Length of Stay in Hospital
Admission Date to Discharge Date, in days
Duration of Chest Tube
Insertion Date to Discharge Date, in days
Intraoperative Complications and Adverse events (AEs)
Short-term clinical outcomes, as measured by intraoperative complications and postoperative AEs, will be recorded during patient follow-ups.
Sponsors and contacts
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