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)
Facility
City
Region
Status
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.
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