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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 3 dimensional display system
pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 2 dimensional display system
Policlinico Tor Vergata University
Roma, Italy
a difference ≥10% in the score calculated for the maneuvring ergonomical domain.
3 ergonomical domains: exposure, instrumentation and maneuvering are assessed by 4 thoracic surgeons using a new scoring scale (score range 1, unsatisfactory to 3 excellent). Primary outcome is a difference ≥10% (sd=0.3) in at least one of the evaluated domains.
Time frame: one week after surgery
Operative time
Total duration (min) of the surgical procedure from first incision opening to last incision closure
Time frame: during surgery
intraoperative bleeding
Total amount of blood (mL) lost during the surgical procedure
Time frame: intraoperative
postoperative drainage volume
Total amount of fluid (mL) collected through the chest drain during in-hospital stay
Time frame: two weeks after surgery
surgical mortality
Fatal complications occurryng within 90 days after surgery
Time frame: 90 days after surgery
complications
Any adverse event recorded perioperatively or after the surgical procedure during in-hospital stay
Time frame: 30 days after surgery
hospital stay
Overall duration (days) of in-hospital stay after the surgical procedure
Time frame: 30 days after surgery
a difference ≥10% in the score calculated for the exposure ergonomical domain.
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Enrollment
70
3 ergonomical domains: exposure, instrumentation and maneuvering are assessed by 4 thoracic surgeons using a new scoring scale (score range 1, unsatisfactory to 3 excellent). Primary outcome is a difference ≥10% (sd=0.3) in at least one of the evaluated domains.
Time frame: one week after surgery
a difference ≥10% in the score calculated for the instrumentation ergonomical domain.
3 ergonomical domains: exposure, instrumentation and maneuvering are assessed by 4 thoracic surgeons using a new scoring scale (score range 1, unsatisfactory to 3 excellent). Primary outcome is a difference ≥10% (sd=0.3) in at least one of the evaluated domains.
Time frame: one week after surgery