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The goal is to compare clinical outcomes, hospital costs, and cost-utility in patients undergoing anatomical lung resections with DaVinci Xi vs Versius platforms
The main questions it aims to answer are:
Participants already undergoing robotic anatomical lung resection as part of their regular medical care will answer quality of life questionnaires preoperatively, at 1, 3, 6, and 12 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Da Vinci | Patients undergoing anatomical lung resection (ALR) with DaVinci Xi |
| |
| Versius | Patients undergoing anatomical lung resection (ALR) with Versius |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| da Vinci Xi Surgical System | Device | Robotic platform used to perform anatomical lung resection (lobectomy or segmentectomy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cost/utility ratio | The cost/utility ratio will be calculated as the incremental cost per quality-adjusted life year (QALY) gained, comparing robotic-assisted thoracic surgery (RATS) with Da Vinci Xi and Versius. Costs will include all direct procedural costs (including consumables, reusable instruments, operating room time, and maintenance costs of equipment), as well as postoperative hospital-related costs. Health outcomes will be expressed in QALYs, derived from validated health-related quality of life measures collected during follow-up. The analysis will be conducted from the healthcare system perspective, and results will be expressed as an incremental cost-effectiveness ratio (ICER).* | Data will be collected preoperatively (baseline), at 1, 3, 6, and 12 months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | Operation time will be defined as the duration of the surgical procedure, measured in minutes from skin incision to skin closure. This variable will be compared between Da Vinci Xi and Versius | Perioperative/periprocedural |
| Conversions |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing elective thoracic surgery at a tertiary referral hospital will be considered for inclusion. The study population will consist of patients scheduled for pulmonary resection for suspected or confirmed malignant lung disease.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Ramón y Cajal | Madrid | Madrid | 28034 | Spain |
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| Versius Surgical System | Device | Robotic platform used to perform anatomical lung resection (lobectomy or segmentectomy) |
|
|
Conversion rate will be defined as the need to convert from RATS to VATS or open thoracotomy during the procedure. The proportion of conversions will be recorded and compared between groups. |
| Perioperative/periprocedural |
| Complications | Postoperative complications will be defined as any adverse events occurring within 30 days after surgery. Complications will be recorded prospectively and classified according to a standardized grading system (e.g., Clavien-Dindo classification). Both overall complication rates and severity grades will be analyzed and compared between groups. | Within 30 days after surgery |
| Lymph nodes yielded | Lymph node yield will be defined as the total number of lymph nodes resected and retrieved during surgery, as reported in the pathological examination. This variable will be used as a surrogate of oncological quality and compared between Da Vinci and Versius groups. | Perioperative/periprocedural |
| Total cost | Total cost will include all direct hospital-related costs associated with the procedure and postoperative care. This encompasses consumables, reusable equipment (with cost allocation), operating room time, hospital stay, and any costs derived from complications or readmissions. | In-hospital (from the day of operation until the day of discharge) |
| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D038481 | Anterior Temporal Lobectomy |
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D019635 | Neurosurgical Procedures |
| D008408 | Mastectomy |
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