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NCT Number: NCT07537556

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pulmonary Nodule, Solitary Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer (NSCLC) Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pulmonary Metastases Respiratory Tract Diseases Respiratory Tract Neoplasms Solitary Pulmonary Nodule Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients that undergo segmentectomy or lobectomy with RATS.

Exclusion criteria

  • Conversion to VATS at the beginning of the procedure

Treatment and study plan

da Vinci Xi Surgical System

Device

Robotic platform used to perform anatomical lung resection (lobectomy or segmentectomy)

Other names: Lobectomy, Segmentectomy

Versius Surgical System

Device

Robotic platform used to perform anatomical lung resection (lobectomy or segmentectomy)

Other names: Lobectomy, Segmentectomy

Primary outcomes

  1. Cost/utility ratio

    Time frame: 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 outcomes

  1. Operation time

    Time frame: 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

  2. Conversions

    Time frame: 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.

  3. Complications

    Time frame: 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.

  4. Lymph nodes yielded

    Time frame: 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.

  5. Total cost

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

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

Acronym: RATS_RYC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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