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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

Clinicaltrials.gov identifier NCT03925103

Recruitment Status Completed

First Posted April 23, 2019

Last update posted April 8, 2020

Study Description

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:Early Stage Non-small-cell Lung Cancer (Stage 1-2)
  • Intervention/Treatment: Procedure: 3D VATS lobectomy
    Procedure: 2D VATS lobectomy
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • 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 2018
  • Actual Primary Completion Date: December 2019
  • Actual Study Completion Date: December 2019
Arms and interventions
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
Outcome Measures
  • 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. surgical mortality [ Time Frame: 90 days after surgery ]
    Fatal complications occurryng within 90 days after surgery
  • 2. postoperative drainage volume [ Time Frame: two weeks after surgery ]
    Total amount of fluid (mL) collected through the chest drain during in-hospital stay
  • 3. Operative time [ Time Frame: during surgery ]
    Total duration (min) of the surgical procedure from first incision opening to last incision closure
  • 4. intraoperative bleeding [ Time Frame: intraoperative ]
    Total amount of blood (mL) lost during the surgical procedure
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 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) score18 II

- History of Neoadjuvant chemotherapy or radiotherapy

- Radiologic evidence of extensive pleural adhesions.

- Age 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.

Contacts and Locations
Contacts
Locations

Italy
Policlinico Tor Vergata University
Roma

Sponsors and Collaborators

University of Rome Tor Vergata

Investigators

Principal Investigator: Eugenio Pompeo, MD Tor Vergata University

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