Comprehensive Prospective Comparison Of Two Robotic Platforms In Anatomical Lung Resections: Clinical Outcomes And Cost-utility Analysis (RATS_RYC)

Comprehensive Prospective Comparison Of Two Robotic Platforms In Anatomical Lung Resections: Clinical Outcomes And Cost-utility Analysis.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Metastases; Pulmonary Nodule, Solitary; Lung Cancer (NSCLC)
• Intervention / Treatment: Device: da Vinci Xi Surgical System; Device: Versius Surgical System

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28034
      • Hospital Universitario Ramon y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Patients that undergo segmentectomy or lobectomy with RATS.

Exclusion Criteria:

• Conversion to VATS at the beginning of the procedure

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Da Vinci; Patients undergoing anatomical lung resection (ALR) with DaVinci Xi	Device: da Vinci Xi Surgical System; Robotic platform used to perform anatomical lung resection (lobectomy or segmentectomy); Other Names: Lobectomy; Segmentectomy
Versius; Patients undergoing anatomical lung resection (ALR) with Versius	Device: Versius Surgical System; Robotic platform used to perform anatomical lung resection (lobectomy or segmentectomy); Other Names: Lobectomy; Segmentectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: RATS; Da Vinci; Lung resection; Versius
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Solitary Pulmonary Nodule; Surgical Procedures, Operative; Mastectomy; Neurosurgical Procedures; Mastectomy, Segmental; Anterior Temporal Lobectomy
• Other Study ID Numbers: 244/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes