Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

University of Rome Tor Vergata

Status: Completed

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

Treatments: Procedure: 2D VATS lobectomy; Procedure: 3D VATS lobectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03925103

2019-1RT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

3D VATS lobectomy

Experimental group

Description:

Patients undergo thoracoscopic lobectomy by a three-dimensional display system

Treatment:

Procedure: 3D VATS lobectomy

2D VATS lobectomy

Active Comparator group

Description:

Patients undergo thoracoscopic lobectomy by a two-dimensional display system

Treatment:

Procedure: 2D VATS lobectomy