Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Medtronic Signia Stapler Patients randomized to this arm will undergo RTS segmentectomy with the Medtronic Signia Stapler. |
Device: Medtronic Signia Stapler
The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery.
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| Experimental: 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. |
Drug: Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling
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.
|
Outcome Measures
Primary Outcome Measures
- Feasibility and safety [Up to 3 weeks post-surgery]
No adverse impacts of the study procedures on participants
- 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 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
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age between 18 and 120 years at time of consent
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Ability to speak and understand English
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Clinical stage I, II or IIIa NSCLC
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Candidate for RTS segmentectomy, as determined by the operating surgeon
Exclusion Criteria:
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Anticoagulation with inability to cease anticoagulant therapy prior to surgery
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Incurable coagulopathy
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Systemic vascular disease or vasculitis
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Not a candidate for RTS segmentectomy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Joseph's Healthcare Hamilton | Hamilton | Ontario | Canada | L8N 4A6 |
Sponsors and Collaborators
- St. Joseph's Healthcare Hamilton
Investigators
- Principal Investigator: Waël C Hanna, MMDCM MBA FRCSC, St. Joseph's Healthcare Hamilton
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15910