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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgeon-Assisted | Active Comparator | Patients randomized to this arm will undergo RTS with the Medtronic Signia Stapler. |
|
| Totally Robotic | Experimental | Patients randomized to this arm will undergo RTS with the Da Vinci Vessel Sealer Extend Energy Device and SureForm Stapler. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Signia Stapler | Device | The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 3 weeks following hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Operating Room Time | Entry into Operating Room to Exit, in minutes | 3 weeks post-surgery |
| Length of Stay in Hospital | Admission Date to Discharge Date, in days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yogita S Patel, BSc | Contact | 905-522-1155 | 35096 | patelys@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Waƫl C Hanna, MDCM, MBA, FRCSC | St. Joseph's Healthcare Hamilton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Vessel Sealer Extend Energy Device and SureForm Stapler | Device | 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. |
|
| 3 weeks post-surgery |
| Duration of Chest Tube | Insertion Date to Discharge Date, in days | 3 weeks post-surgery |
| 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. | 3 weeks post-surgery |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |