Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lung Cancer, Thoracic Cancer, Lung Neoplasm

Intervention / Treatment
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* Device: Medtronic Signia Stapler
* Drug: Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Anticoagulation with inability to cease anticoagulant therapy prior to surgery Incurable coagulopathy Systemic vascular disease or vasculitis Not a candidate for RTS segmentectomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medtronic Signia Stapler<br>Patients randomized to this arm will undergo RTS segmentectomy with the Medtronic Signia Stapler. | Device: Medtronic Signia Stapler<br>* The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery.<br>|
| Experimental: Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling<br>Patients randomized to this arm will undergo RTS segmentectomy with the Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling. | Drug: Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling<br>* The Vessel Sealer Extend Energy Device is integrated with the da Vinci system and uses bipolar energy technology to facilitate tissue dissection and vessel sealing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and safety | No adverse impacts of the study procedures on participants | Up to 3 weeks post-surgery | 
| Recruitment | Recruitment rate of at least 70% | Up to 8 weeks after recruitment first opens | 
| Randomization | Ability to randomize patients to one of two groups | Baseline | 
| Data collection of stapler reload model | Ability to collect the type of stapler reloads used | Up to 3 weeks post-surgery | 
| Data collection of stapler quantities | Ability to collect the number of stapler reloads used | Up to 3 weeks post-surgery | 
| Data collection of energy sealing data | Ability to collect the sealing time in seconds | Up to 3 weeks post-surgery | 
| Data collection of energy device data | Ability to collect the generator setting of the energy device | Up to 3 weeks post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) and complications | Short-term clinical outcomes, as measured by postoperative AEs and complications, will be recorded during patient follow-ups. | 3 weeks post-surgery | 
| Intraoperative costs of stapler or energy device use | Surgical device (stapler or energy) costs per surgery will be collected and evaluated in Canadian dollars. | Up to 3 weeks following hospital discharge | 
| Hospitalization costs based on length of hospital stay | Inpatient hospitalization costs per day following surgery will be collected in Canadian dollars. | From admission to discharge, up to 14 days |