Trials / Completed
CompletedNCT03925103
Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy
Ergonomical Assessment of Three-Dimensional Versus Two-Dimensional Thoracoscopic Lobectomy for Lung Cancer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- University of Rome Tor Vergata · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Video-assisted thoracic surgery (VATS) pulmonary lobectomy is currently widely employed as the first treatment option for surgical management of early stage (stage I-II) non-small-cell-lung-cancer (NSCLC). Thanks to recent technological advances in high definition display systems, three dimensional VATS (3D) has been developed in an attempt of overcoming some optical limits of two dimensional (2D) VATS. In this single center randomized trial our aim is to comparatively assess ergonomics of 3D versus 2D VATS lobectomy for early stage NSCLC.
Detailed description
Video-assisted thoracic surgery (VATS) is widely employed for pulmonary lobectomy in early stage non-small-cell-lung-cancer (NSCLC). Indeed, VATS is thought to represent an optimal minimally invasive surgical option which is deemed superior to conventional thoracotomy since it enables smaller incisions with no rib spreading thus minimizing both postoperative pain and hospital stay. For over than three decades, several thoracic surgeons adopted VATS for anatomical lung resection using two-dimensional (2D) display systems. However, a 2D image lacks depth of perception which may negatively affect surgical manoeuvring. Three dimensional (3D) display systems for VATS can offer superior magnified vision of the surgical field and better perception of depth during surgical manoeuvring potentially shortening learning curve, which may thus overcome some optical limitations of 2D systems. In this single center randomized trial our aim is to comparatively assess ergonomics of 3D versus 2D VATS lobectomy for early stage (stage I-II) NSCLC. For this purpose we compared three ergonomical domains: exposure, instrumentation and maneuvering with the aid of a scoring scale entailing analysis of 5 main technical steps: vein, artery bronchus, lymph node and fissure score. The evaluation process of the five surgical steps was carried out by 4 thoracic surgeons who individually scored all recorded operations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 3D VATS lobectomy | pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 3 dimensional display system |
| PROCEDURE | 2D VATS lobectomy | pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 2 dimensional display system |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
- First posted
- 2019-04-23
- Last updated
- 2020-04-08
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03925103. Inclusion in this directory is not an endorsement.