To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.
Detection of lung cancer is occurring at increasingly earlier stages due to improved screening and the discovery of incidental nodules. Coinciding with this trend is recent data from two international randomized, control trials, RAVAL - (Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer) and, JCOG0802 (The Japan Clinical Oncology Group) that show oncologic outcomes from segmentectomy are equivalent to lobectomy for cancers ≤2 cm. However, segmentectomy is a more complex technical operation that may not be easily feasible using video assisted thoracic surgery (VATS) but could be facilitated by robotic-assisted thoracic surgery (RATS), allowing improved vision, precision and controlled anatomic dissection. The LARCS study is designed to understand the perioperative outcomes of patients and identify the real-world selection process of either VATS and RATS segmentectomy and lobectomy for lung cancers ≤2 cm. It aims to generate evidence to support integration of patient-centered care using minimally invasive technology. In addition, health related quality of life captured in the study will also provide valuable insight into time to recovery, determining burden of the disease, and guide future treatment strategy.
Study Type
OBSERVATIONAL
Enrollment
512
Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.
Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.
AP-HM
Marseille, France
RECRUITINGCHU de Rouen
Rouen, France
RECRUITINGCHU de Toulouse
Patient reported Quality of Life 1
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.
Time frame: 1 month post surgery
Patient reported Quality of Life 2
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.
Time frame: 1 month post surgery
Number of conversions from pre-operative surgical plan
Number of participants who undergo conversion surgery from the pre-operative surgical plan captured on the surgical decision making form. Conversion may be from segmentectomy to lobetomy, RATS or VATS to open surgery.
Time frame: immediately post operative
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Toulouse, France
Thoraxklinik
Heidelberg, Germany
RECRUITINGKrankenhaus Barmherzige Brüder
Regensburg, Germany
RECRUITINGAzienda Ospedaliero Universitaria Pisana
Pisa, Italy
RECRUITINGAkershus University Hospital
Loerenskog, Norway
RECRUITINGUniversity Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom
RECRUITINGUniversity Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom
RECRUITINGGuy's and St Thomas' NHS Foundation Trust
London, United Kingdom
RECRUITING...and 1 more locations