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Active Not RecruitingNCT02617186

Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: RCT

Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: A Randomized Controlled Trial

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
446 (actual)
Sponsor
St. Joseph's Healthcare Hamilton · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREVideo-assisted thoracoscopic surgerypatients randomized to this arm will receive video-assisted thoracic surgery (VATS)
PROCEDURERobotic thoracic surgerypatients randomized to this arm will receive robotic thoracic surgery (RTS) with the da Vinci Robot

Timeline

Start date
2016-01-01
Primary completion
2021-09-01
Completion
2031-09-01
First posted
2015-11-30
Last updated
2025-09-12

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02617186. Inclusion in this directory is not an endorsement.