Clinical trial NCT03925103: Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy
Official title: Ergonomical Assessment of Three-Dimensional Versus Two-Dimensional Thoracoscopic Lobectomy for Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Stage Non-small-cell Lung Cancer (Stage 1-2)
Keywords: VATS
Lobectomy
3D VATS
VATS Ergonomics
Non small cell lung cancer
Three-dimensional thoracoscopy
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One to one parallel assignment to each treatment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: a difference ≥10% in the score calculated for the maneuvring ergonomical domain.
timeFrame: one week after surgery
Secondary outcomes:
measure: Operative time
timeFrame: during surgery
measure: intraoperative bleeding
timeFrame: intraoperative
measure: postoperative drainage volume
timeFrame: two weeks after surgery
measure: surgical mortality
timeFrame: 90 days after surgery
measure: complications
timeFrame: 30 days after surgery
measure: hospital stay
timeFrame: 30 days after surgery
measure: a difference ≥10% in the score calculated for the exposure ergonomical domain.
timeFrame: one week after surgery
measure: a difference ≥10% in the score calculated for the instrumentation ergonomical domain.
timeFrame: one week after surgery
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Tor Vergata University
Study officials:
affiliation: Tor Vergata University
name: Eugenio Pompeo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scott WJ, Allen MS, Darling G, Meyers B, Decker PA, Putnam JB, McKenna RW, Landrenau RJ, Jones DR, Inculet RI, Malthaner RA. Video-assisted thoracic surgery versus open lobectomy for lung cancer: a secondary analysis of data from the American College of Surgeons Oncology Group Z0030 randomized clinical trial. J Thorac Cardiovasc Surg. 2010 Apr;139(4):976-81; discussion 981-3. doi: 10.1016/j.jtcvs.2009.11.059. Epub 2010 Feb 20.
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citation: Yan TD, Black D, Bannon PG, McCaughan BC. Systematic review and meta-analysis of randomized and nonrandomized trials on safety and efficacy of video-assisted thoracic surgery lobectomy for early-stage non-small-cell lung cancer. J Clin Oncol. 2009 May 20;27(15):2553-62. doi: 10.1200/JCO.2008.18.2733. Epub 2009 Mar 16.