Early Stage Non-small-cell Lung Cancer (Stage 1-2)
Conditions
Keywords
VATS, Lobectomy, 3D VATS, VATS Ergonomics, Non small cell lung cancer, Three-dimensional thoracoscopy
Brief 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.
Interventions
PROCEDURE3D VATS lobectomy
pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 3 dimensional display system
PROCEDURE2D VATS lobectomy
pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 2 dimensional display system
Sponsors
University of Rome Tor Vergata
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
One to one parallel assignment to each treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical NSCLC early stage (stage I-II). * Both forced expiratory volume in one second (FEV1) and diffusion capacity of carbon monoxide (DLCO)\>60% * Both predicted postoperative (PPO) FEV1 and PPO DLCO \>35% * American Society of Anesthesia (ASA) score\<=2 * Body mass index (BMI) \>18 \<28
Exclusion criteria
* Clinical NSCLC stage\> II * History of Neoadjuvant chemotherapy or radiotherapy * Radiologic evidence of extensive pleural adhesions. * Age \<18 or \>80 years. * Patients with previous pleurodesis or thoracotomy in the affected hemithorax. * Patients who will undergo surgical lung resection other than lobectomy. * Patients with severe comorbidity contraindicating lobectomy. * Patients refusal or noncompliance to general surgery and one-lung ventilation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| a difference ≥10% in the score calculated for the maneuvring ergonomical domain. | one week after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative bleeding | intraoperative | Total amount of blood (mL) lost during the surgical procedure |
| postoperative drainage volume | two weeks after surgery | Total amount of fluid (mL) collected through the chest drain during in-hospital stay |
| surgical mortality | 90 days after surgery | Fatal complications occurryng within 90 days after surgery |
| Operative time | during surgery | Total duration (min) of the surgical procedure from first incision opening to last incision closure |
| hospital stay | 30 days after surgery | Overall duration (days) of in-hospital stay after the surgical procedure |
| a difference ≥10% in the score calculated for the exposure ergonomical domain. | one week after surgery | 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. |
| a difference ≥10% in the score calculated for the instrumentation ergonomical domain. | one week after surgery | 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. |
| complications | 30 days after surgery | Any adverse event recorded perioperatively or after the surgical procedure during in-hospital stay |
Countries
Italy
Outcome results
None listed