Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

April 7, 2020 updated by: Eugenio Pompeo, University of Rome Tor Vergata

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00133
        • Policlinico Tor Vergata University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Investigators

  • Principal Investigator: Eugenio Pompeo, MD, Tor Vergata University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

February 27, 2019

First Submitted That Met QC Criteria

April 20, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1RT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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