Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy
- Conditions
- Lung CancerLung NeoplasmThoracic Cancer
- Interventions
- Device: Medtronic Signia StaplerDrug: Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling
- Registration Number
- NCT05727735
- Lead Sponsor
- St. Joseph's Healthcare Hamilton
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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
- Anticoagulation with inability to cease anticoagulant therapy prior to surgery
- Incurable coagulopathy
- Systemic vascular disease or vasculitis
- Not a candidate for RTS segmentectomy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medtronic Signia Stapler Medtronic Signia Stapler Patients randomized to this arm will undergo RTS segmentectomy with the Medtronic Signia Stapler. Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling 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.
- Primary Outcome Measures
Name Time Method Feasibility and safety Up to 3 weeks post-surgery No adverse impacts of the study procedures on participants
Data collection of stapler quantities Up to 3 weeks post-surgery Ability to collect the number of stapler reloads used
Data collection of energy sealing data Up to 3 weeks post-surgery Ability to collect the sealing time in seconds
Recruitment Up to 8 weeks after recruitment first opens Recruitment rate of at least 70%
Randomization Baseline Ability to randomize patients to one of two groups
Data collection of stapler reload model Up to 3 weeks post-surgery Ability to collect the type of stapler reloads used
Data collection of energy device data Up to 3 weeks post-surgery Ability to collect the generator setting of the energy device
- Secondary Outcome Measures
Name Time Method Adverse events (AEs) and complications 3 weeks post-surgery Short-term clinical outcomes, as measured by postoperative AEs and complications, will be recorded during patient follow-ups.
Intraoperative costs of stapler or energy device use Up to 3 weeks following hospital discharge Surgical device (stapler or energy) costs per surgery will be collected and evaluated in Canadian dollars.
Hospitalization costs based on length of hospital stay From admission to discharge, up to 14 days Inpatient hospitalization costs per day following surgery will be collected in Canadian dollars.
Trial Locations
- Locations (1)
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada