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Videothoracoscopic (VATS) vs. Robotic Approach for Lobectomy or Anatomical Segmentectomy
NCT02804893 · Istituto Clinico Humanitas · Updated 20 Dec 2018
- What is being tested
- VATS; RATS
- For
- Lung Cancer
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 300 people. The full rules are on the registry page.
- Where
- Italy
- When
- Starts or started 6 March 2017, ends 6 March 2023. Registered 17 June 2016.
- Results
- None posted yet.
In the researchers' words
This is a prospective, randomized, multicenter study on 300 patients (150 VATS lobectomies and 150 robotic lobectomies) affected by early stage (I-II) lung cancer. The expected recruitment is one year and two year follow up. Surgeons should have a minimum of 30 major lung resections performed using one of the two techniques for participation in the study. Each participating centers should have the possibility to offer both techniques (Robotics and Vats). The primary end point is a combination of conversion and complication rate. The presence of at least one of the two events is considered a failure. Considering the rate of failure of 35% in the VATS arm, we want to see a failure rate not over 20% in the robot arm, so with a power of 80% and an alpha error of 5%, we need a total of 300 patients.
Sites
- Thoracic surgery Division, Istituto Clinico HumanitasRozzano, Milan, Italy