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NCT Number: NCT03925103

Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

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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Key information

Conditions

Early Stage Non-small-cell Lung Cancer (Stage 1-2) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Tor Vergata University

Roma, 00133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D VATS lobectomy

Procedure

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

2D VATS lobectomy

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Operative time

    Time frame: during surgery

    Total duration (min) of the surgical procedure from first incision opening to last incision closure

  2. intraoperative bleeding

    Time frame: intraoperative

    Total amount of blood (mL) lost during the surgical procedure

  3. postoperative drainage volume

    Time frame: two weeks after surgery

    Total amount of fluid (mL) collected through the chest drain during in-hospital stay

  4. surgical mortality

    Time frame: 90 days after surgery

    Fatal complications occurryng within 90 days after surgery

  5. complications

    Time frame: 30 days after surgery

    Any adverse event recorded perioperatively or after the surgical procedure during in-hospital stay

  6. hospital stay

    Time frame: 30 days after surgery

    Overall duration (days) of in-hospital stay after the surgical procedure

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2019
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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