Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-12-31

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One to one parallel assignment to each treatment

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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3D VATS lobectomy

Patients undergo thoracoscopic lobectomy by a three-dimensional display system

Group Type EXPERIMENTAL

3D VATS lobectomy

Intervention Type PROCEDURE

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

2D VATS lobectomy

Patients undergo thoracoscopic lobectomy by a two-dimensional display system

Group Type ACTIVE_COMPARATOR

2D VATS lobectomy

Intervention Type PROCEDURE

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

Interventions

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3D VATS lobectomy

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

Intervention Type PROCEDURE

2D VATS lobectomy

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

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No