Lung Cancer (NSCLC), Pulmonary Metastases, Pulmonary Nodule, Solitary
Conditions
Keywords
RATS, Da Vinci, Versius, Lung resection
Brief summary
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: * Do patients that undergo an anatomical lung resection with DaVinci Xi have the same clinical outcomes (complications, stay...) than those who were operated with Versius? * Are anatomical lung resections performed with DaVinci Xi more expensive than those performed with Versius? * Are anatomical lung resection performed with DaVinci Xi more cost-effective than those performed with Versius? 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.
Interventions
DEVICEda Vinci Xi Surgical System
Robotic platform used to perform anatomical lung resection (lobectomy or segmentectomy)
DEVICEVersius Surgical System
Robotic platform used to perform anatomical lung resection (lobectomy or segmentectomy)
Sponsors
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients that undergo segmentectomy or lobectomy with RATS.
Exclusion criteria
* Conversion to VATS at the beginning of the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost/utility ratio | Data will be collected preoperatively (baseline), at 1, 3, 6, and 12 months after surgery. | 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).\* |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | Perioperative/periprocedural | 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 |
| Conversions | Perioperative/periprocedural | 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. |
| Complications | Within 30 days after surgery | 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. |
| Lymph nodes yielded | Perioperative/periprocedural | 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. |
| Total cost | In-hospital (from the day of operation until the day of discharge) | 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. |
Countries
Spain
Outcome results
None listed