Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ergonomical Assessment of Three-Dimensional Versus Two-Dimensional Thoracoscopic Lobectomy for Lung Cancer

Conditions
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Early Stage Non-small-cell Lung Cancer (Stage 1-2)

Intervention / Treatment
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* Procedure: 3D VATS lobectomy
* Procedure: 2D VATS lobectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One to one parallel assignment to each treatment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D VATS lobectomy<br>Patients undergo thoracoscopic lobectomy by a three-dimensional display system | Procedure: 3D VATS lobectomy<br>* pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 3 dimensional display system<br>|
| Active Comparator: 2D VATS lobectomy<br>Patients undergo thoracoscopic lobectomy by a two-dimensional display system | Procedure: 2D VATS lobectomy<br>* pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 2 dimensional display system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Total duration (min) of the surgical procedure from first incision opening to last incision closure | during surgery | 
| intraoperative bleeding | Total amount of blood (mL) lost during the surgical procedure | intraoperative | 
| postoperative drainage volume | Total amount of fluid (mL) collected through the chest drain during in-hospital stay | two weeks after surgery | 
| surgical mortality | Fatal complications occurryng within 90 days after surgery | 90 days after surgery | 
| complications | Any adverse event recorded perioperatively or after the surgical procedure during in-hospital stay | 30 days after surgery | 
| hospital stay | Overall duration (days) of in-hospital stay after the surgical procedure | 30 days after surgery | 
| a difference ≥10% in the score calculated for the exposure 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. | 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. | one week after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VATS, Lobectomy, 3D VATS, VATS Ergonomics, Non small cell lung cancer, Three-dimensional thoracoscopy