During video-assisted thoracoscopic lobectomy (VATS), the surgeon inserts a small camera attached to a thoracoscope that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed. 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. The instruments give the surgeons increased range of motion during the surgery, and research demonstrates that RTS has a less steep learning curve as compared to VATS. Both VATS and RTS demonstrated better results as compared to traditional thoracotomy (open surgery). However, Robotic lobectomy has not yet been compared directly to video-assisted thoracoscopic lobectomy (VATS) in a prospective manner. There are two major barriers against the widespread adoption of robotic thoracic surgery. The first barrier is the lack of high-quality prospective data. To our knowledge, there are no prospective trials comparing VATS to RTS for early stage lung cancer. The second major barrier to the widespread adoption of robotic technology in thoracic surgery is the perceived higher cost of Robotic lobectomy. To address these barriers, the investigators will undertake the first randomized controlled trial comparing Thoracoscopic Lobectomy to Robotic Lobectomy for early stage lung cancer. Prospective randomization will eliminate the biases of retrospective data and will serve to determine whether there exist any advantages to Health Related Quality of life (HRQOL) or patient outcomes in favour of Robotic Lobectomy over VATS Lobectomy. Furthermore, through a prospective cost-utility analysis, this trial will provide the highest quality data to evaluate the true economic impact of robotic technology in thoracic surgery in a Canadian health system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
446
patients randomized to this arm will receive video-assisted thoracic surgery (VATS)
patients randomized to this arm will receive robotic thoracic surgery (RTS) with the da Vinci Robot
McMaster University / St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Difference in HRQOL scores at week 12 between the treatment groups
Difference in HRQOL scores between the treatment groups, as measured by the EQ-5D-5L questionnaire at week 12.
Time frame: 12 weeks post-surgery
Short-term clinical outcome differences
Clinical staging will be determined from diagnostic imaging reports
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Pathological staging will be determined from pathology report
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Number of lymph nodes sampled
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Admission date
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Date of surgery
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Discharge date
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Chest tube removal date
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Intraoperative blood loss
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Post-operative analgesia will be determined from list of prescribed pain medications
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Post-surgical pain will be determined from the Numeric Pain Rating Scale
Time frame: 3 weeks post-surgery
Resource utilization
Operating room time
Time frame: 1 year post-surgery
Resource utilization
Operating room staff
Time frame: 1 year post-surgery
Resource utilization
Surgical instruments and consumables
Time frame: 1 year post-surgery
Resource utilization
Admission to critical care beds
Time frame: 1 year post-surgery
Resource utilization
Hospital length of stay
Time frame: 1 year post-surgery
Resource utilization
Duration of intravenous analgesia
Time frame: 1 year post-surgery
Resource utilization
Postoperative complications
Time frame: 1 year post-surgery
Resource utilization
Costs associated with chronic post-surgical pain up to one year after surgery.
Time frame: 1 year post-surgery
Cost Effectiveness
The incremental cost per quality-adjusted life year (QALY) gained will be calculated to assess cost effectiveness.
Time frame: 5 years post-surgery
Difference in HRQOL scores between the treatment groups
Difference in HRQOL scores between the treatment groups, as measured by the EQ-5D-5L questionnaire at weeks 3 and 7; months 6, 12, 18, 24; and years 3, 4, and 5, which coincide with the intervals of oncological surveillance.
Time frame: 3, 7 weeks post-surgery; 6 months post-surgery; 1, 1.5, 2, 3, 4, 5 years post-surgery
Difference in 5-year survival rate between the two groups
Difference in 5-year survival rate between the two groups.
Time frame: 5 years post-surgery
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