Robotic vs Standard Keyhole Surgery for Early-Stage Lung Cancer: An Australian Randomised Controlled Trial (RAVAL)
Intervencionista
Fase no especificada
Investigative Site
Patrocinador: St Vincent's Hospital Melbourne
Última actualización: 5 de agosto de 2024
Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.
This trial aims to determine if there is any difference in patient-reported health-related quality of life and other clinical outcomes for patients with early-stage non-small cell lung cancer (NSCLC) who will undergo surgical removal of their cancer by either robotic keyhole surgery (RTS) or video assisted keyhole surgery (VATS).
Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with early-stage non-small cell lung cancer and you are able to undergo minimally invasive keyhole surgery for removal of your cancer. Your treating doctor will be able to review your lung images to determine whether this type of surgery is right for you.
Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to undergo surgery by one of two methods. Participants allocated to the first group will undergo robotic-assisted keyhole surgery, it is anticipated this procedure take up to 3 hours. Robotic thoracic surgery (RTS) uses a similar minimally invasive approach, but the very precise instruments involved with RTS allow the surgeon to view the lung using 3-dimensional imaging. Participants allocated to the second group will undergo video-assisted keyhole surgery, it is anticipated that this procedure will take up to 3 hours. During video-assisted keyhole surgery (VATS), the surgeon inserts a small camera into the lung that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed.
Both types of surgery are currently standard of care to successfully remove lung cancer. It is expected that participants in both groups will need to stay in hospital after their surgery to ensure there are no unexpected complications. If you choose to participate in this study, the research team will ask to review your medical records prior to the surgery and for up to 5 years after the surgery to follow your progress.
It is hoped this research will demonstrate any differences in patient outcomes following each type of surgery. If one surgical method is found to be more effective for removal of cancer and less painful for patients, the evidence gathered from this trial may be used to promote use of that surgical method for future cancer patients.
• Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)
• Candidates for minimally invasive pulmonary surgery, as determined by the operating surgeon.
Criterios de exclusión
• Not a candidate for minimally invasive lobectomy
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Detalles del diseño
AsignaciónRandomised controlled trial
Modelo de intervenciónParallel
EnmascaramientoBlinded (masking used)
Número a inscribir180
Brazos e Intervenciones
Brazos
Intervenciones
No hay intervenciones disponibles.
Medidas de resultado
Medidas de resultado primarias
Health related Quality of Life (HRQOL).12 weeks post surgery.
The trial is intended to determine the difference in participant-reported HRQOL outcomes between RTS-Lobectomy and VATS-Lobectomy at 12 weeks.
Medidas de resultado secundarias
Difference in quality of life between the treatment groups, as measured by which coincide with standard of care intervals of oncological surveillance.Weeks 3 and 7 and 12; months 6, 12, 18, 24; and years 3, 4, and 5,
The Health-Related Quality of Life questionnaire
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