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Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

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ClinicalTrials.gov Identifier: NCT03925103
Recruitment Status : Completed
First Posted : April 23, 2019
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Eugenio Pompeo, 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.


Condition or disease Intervention/treatment Phase
Early Stage Non-small-cell Lung Cancer (Stage 1-2) Procedure: 3D VATS lobectomy Procedure: 2D VATS lobectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One to one parallel assignment to each treatment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ergonomical Assessment of Three-Dimensional Versus Two-Dimensional Thoracoscopic Lobectomy for Lung Cancer
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ergonomics

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925103


Locations
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Italy
Policlinico Tor Vergata University
Roma, Italy, 00133
Sponsors and Collaborators
University of Rome Tor Vergata
Investigators
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Principal Investigator: Eugenio Pompeo, MD Tor Vergata University
Publications:

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Responsible Party: Eugenio Pompeo, Principal Investigator, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT03925103    
Other Study ID Numbers: 2019-1RT
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eugenio Pompeo, University of Rome Tor Vergata:
VATS
Lobectomy
3D VATS
VATS Ergonomics
Non small cell lung cancer
Three-dimensional thoracoscopy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms