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

Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

Sponsors

Lead sponsor: University of Rome Tor Vergata

Source University of Rome Tor Vergata
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.

Overall Status Completed
Start Date October 1, 2018
Completion Date December 31, 2019
Primary Completion Date December 31, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
a difference ≥10% in the score calculated for the maneuvring ergonomical domain. one week after surgery
Secondary Outcome
Measure Time Frame
Operative time during surgery
intraoperative bleeding intraoperative
postoperative drainage volume two weeks after surgery
surgical mortality 90 days after surgery
complications 30 days after surgery
hospital stay 30 days after surgery
a difference ≥10% in the score calculated for the exposure ergonomical domain. one week after surgery
a difference ≥10% in the score calculated for the instrumentation ergonomical domain. one week after surgery
Enrollment 70
Condition
Intervention

Intervention type: Procedure

Intervention name: 3D VATS lobectomy

Description: pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 3 dimensional display system

Arm group label: 3D VATS lobectomy

Intervention type: Procedure

Intervention name: 2D VATS lobectomy

Description: pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 2 dimensional display system

Arm group label: 2D VATS lobectomy

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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Eugenio Pompeo, MD Principal Investigator Tor Vergata University
Location
facility Policlinico Tor Vergata University
Location Countries

Italy

Verification Date

April 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Rome Tor Vergata

Investigator full name: Eugenio Pompeo

Investigator title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: 3D VATS lobectomy

Arm group type: Experimental

Description: Patients undergo thoracoscopic lobectomy by a three-dimensional display system

Arm group label: 2D VATS lobectomy

Arm group type: Active Comparator

Description: Patients undergo thoracoscopic lobectomy by a two-dimensional display system

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: One to one parallel assignment to each treatment

Primary purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov