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Recruiting Observational

Lung cAncer Robotic Comparative Study

NCT06038227 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-07-15
Last updated
2026-09-14

Condition(s) studied

Lung Cancer

Investigational drug(s) / intervention(s)

Robotic Assisted Thoracic SurgeryVideo Assisted Thoracic Surgery

Robotic Assisted Thoracic Surgery: Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.

Video Assisted Thoracic Surgery: Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.

Study summary

To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient diagnosed with clinical stage IA1-2 non-small cell lung cancer at time of procedure * Patient scheduled to undergo minimally invasive surgery for NSCLC with either da Vinci robotic assisted surgery or VATs * Aged ≥ 18 years * Must be willing and able to comply with study requirements * Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form Exclusion Criteria: * Patients with clinical stage IA3, II, III, and IV lung cancer * Patient receiving a lobectomy/segmentectomy as an emergency procedure * Patients receiving a lobectomy/segmentectomy for metastatic cancer * Patients scheduled to receive a bilobectomy or sleeve-lobectomy * Mental incapacity to understand or consent to study procedures * Anticipated difficulty for patient to comply with protocol requirements * Unable to comply with the follow up schedule * Pregnant or are planning to become pregnant during the study * Life expectancy \< 12 months

Primary outcome measure(s)

  • Patient reported Quality of Life 1 — 1 month post surgery
    EQ 5D 5L (European Quality of Life Five Dimension) The EQ-5D-5L is a validated and established generic Patient Reported Outcome (PRO) instrument that uses 6 questions to assess patients' quality of life. It includes a vertical EQ visual analog scale (EQ VAS, 0-100 points) and a descriptive EQ-5D-5L system. An algorithm is used to calculate the scores. For the descriptive section of the scale, an index value of 1 represents the best possible health state, while an index value of \<0 (variable) represents the worst possible health state. The EQ VAS score is rated on a scale of 0-100 points. 0 points correspond to the worst possible health status, while 100 points correspond to the best possible health status.
  • Patient reported Quality of Life 2 — 1 month post surgery
    RNLI (Reintegration to Normal Living Index) The RNLI has 11 questions and is scored on a visual analogue scale (VAS). On one end: "does not describe my situation" (1 or minimal integration) and "fully describes my situation" (10 or complete integration). Individual item scores are summed to provide the total score. The higher the score, the better the patients perceived integration.

Trial sites (13)

FacilityCityRegionStatus
Copenhagen University Hospital Rigshospitalet Copenhagen Denmark Recruiting
AP-HM Marseille France Recruiting
CHU de Rouen Rouen France Recruiting
CHU de Toulouse Toulouse France Recruiting
Thoraxklinik Heidelberg Germany Recruiting
Krankenhaus Barmherzige Brüder Regensburg Germany Recruiting
Azienda Ospedaliero Universitaria Pisana Pisa Italy Recruiting
Akershus University Hospital Loerenskog Norway Recruiting
University Hospital Zurich Zurich Switzerland Recruiting
University Hospitals Bristol and Weston NHS Foundation Trust Bristol United Kingdom Recruiting
University Hospitals Coventry and Warwickshire NHS Trust Coventry United Kingdom Recruiting
Guy's and St Thomas' NHS Foundation Trust London United Kingdom Recruiting
St Bartholomew Hospital London United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06038227 on ClinicalTrials.gov ↗ ← All trials in Italy