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Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
3D VATS lobectomy
2D VATS lobectomy
Sponsored by
University of Rome Tor Vergata
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Stage Non-small-cell Lung Cancer (Stage 1-2) focused on measuring VATS, Lobectomy, 3D VATS, VATS Ergonomics, Non small cell lung cancer, Three-dimensional thoracoscopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Policlinico Tor Vergata University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3D VATS lobectomy

2D VATS lobectomy

Arm Description

Patients undergo thoracoscopic lobectomy by a three-dimensional display system

Patients undergo thoracoscopic lobectomy by a two-dimensional display system

Outcomes

Primary Outcome Measures

a difference ≥10% in the score calculated for the maneuvring ergonomical domain.
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

Operative time
Total duration (min) of the surgical procedure from first incision opening to last incision closure
intraoperative bleeding
Total amount of blood (mL) lost during the surgical procedure
postoperative drainage volume
Total amount of fluid (mL) collected through the chest drain during in-hospital stay
surgical mortality
Fatal complications occurryng within 90 days after surgery
complications
Any adverse event recorded perioperatively or after the surgical procedure during in-hospital stay
hospital stay
Overall duration (days) of in-hospital stay after the surgical procedure
a difference ≥10% in the score calculated for the exposure ergonomical domain.
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.
a difference ≥10% in the score calculated for the instrumentation ergonomical domain.
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.

Full Information

First Posted
February 27, 2019
Last Updated
April 7, 2020
Sponsor
University of Rome Tor Vergata
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1. Study Identification

Unique Protocol Identification Number
NCT03925103
Brief Title
Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy
Official Title
Ergonomical Assessment of Three-Dimensional Versus Two-Dimensional Thoracoscopic Lobectomy for Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rome Tor Vergata

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Non-small-cell Lung Cancer (Stage 1-2)
Keywords
VATS, Lobectomy, 3D VATS, VATS Ergonomics, Non small cell lung cancer, Three-dimensional thoracoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One to one parallel assignment to each treatment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3D VATS lobectomy
Arm Type
Experimental
Arm Description
Patients undergo thoracoscopic lobectomy by a three-dimensional display system
Arm Title
2D VATS lobectomy
Arm Type
Active Comparator
Arm Description
Patients undergo thoracoscopic lobectomy by a two-dimensional display system
Intervention Type
Procedure
Intervention Name(s)
3D VATS lobectomy
Intervention Description
pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 3 dimensional display system
Intervention Type
Procedure
Intervention Name(s)
2D VATS lobectomy
Intervention Description
pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 2 dimensional display system
Primary Outcome Measure Information:
Title
a difference ≥10% in the score calculated for the maneuvring ergonomical domain.
Description
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.
Time Frame
one week after surgery
Secondary Outcome Measure Information:
Title
Operative time
Description
Total duration (min) of the surgical procedure from first incision opening to last incision closure
Time Frame
during surgery
Title
intraoperative bleeding
Description
Total amount of blood (mL) lost during the surgical procedure
Time Frame
intraoperative
Title
postoperative drainage volume
Description
Total amount of fluid (mL) collected through the chest drain during in-hospital stay
Time Frame
two weeks after surgery
Title
surgical mortality
Description
Fatal complications occurryng within 90 days after surgery
Time Frame
90 days after surgery
Title
complications
Description
Any adverse event recorded perioperatively or after the surgical procedure during in-hospital stay
Time Frame
30 days after surgery
Title
hospital stay
Description
Overall duration (days) of in-hospital stay after the surgical procedure
Time Frame
30 days after surgery
Title
a difference ≥10% in the score calculated for the exposure ergonomical domain.
Description
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.
Time Frame
one week after surgery
Title
a difference ≥10% in the score calculated for the instrumentation ergonomical domain.
Description
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.
Time Frame
one week after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugenio Pompeo, MD
Organizational Affiliation
Tor Vergata University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Tor Vergata University
City
Roma
ZIP/Postal Code
00133
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20172539
Citation
Scott WJ, Allen MS, Darling G, Meyers B, Decker PA, Putnam JB, McKenna RW, Landrenau RJ, Jones DR, Inculet RI, Malthaner RA. Video-assisted thoracic surgery versus open lobectomy for lung cancer: a secondary analysis of data from the American College of Surgeons Oncology Group Z0030 randomized clinical trial. J Thorac Cardiovasc Surg. 2010 Apr;139(4):976-81; discussion 981-3. doi: 10.1016/j.jtcvs.2009.11.059. Epub 2010 Feb 20.
Results Reference
background
PubMed Identifier
19619789
Citation
Villamizar NR, Darrabie MD, Burfeind WR, Petersen RP, Onaitis MW, Toloza E, Harpole DH, D'Amico TA. Thoracoscopic lobectomy is associated with lower morbidity compared with thoracotomy. J Thorac Cardiovasc Surg. 2009 Aug;138(2):419-25. doi: 10.1016/j.jtcvs.2009.04.026.
Results Reference
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PubMed Identifier
29049786
Citation
Xu Y, Chen N, Ma A, Wang Z, Zhang Y, Liu C, Liu L. Three-dimensional versus two-dimensional video-assisted thoracic surgery for thoracic disease: a meta-analysis. Interact Cardiovasc Thorac Surg. 2017 Dec 1;25(6):862-871. doi: 10.1093/icvts/ivx219.
Results Reference
background
PubMed Identifier
25736286
Citation
Bagan P, De Dominicis F, Hernigou J, Dakhil B, Zaimi R, Pricopi C, Le Pimpec Barthes F, Berna P. Complete thoracoscopic lobectomy for cancer: comparative study of three-dimensional high-definition with two-dimensional high-definition video systems dagger. Interact Cardiovasc Thorac Surg. 2015 Jun;20(6):820-3. doi: 10.1093/icvts/ivv031. Epub 2015 Mar 3.
Results Reference
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PubMed Identifier
27755803
Citation
Jiao P, Wu QJ, Sun YG, Ma C, Tian WX, Yu HB, Tong HF. Comparative study of three-dimensional versus two-dimensional video-assisted thoracoscopic two-port lobectomy. Thorac Cancer. 2017 Jan;8(1):3-7. doi: 10.1111/1759-7714.12387. Epub 2016 Oct 4.
Results Reference
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PubMed Identifier
27766782
Citation
Dong S, Yang XN, Zhong WZ, Nie Q, Liao RQ, Lin JT, Wu YL. Comparison of three-dimensional and two-dimensional visualization in video-assisted thoracoscopic lobectomy. Thorac Cancer. 2016 Sep;7(5):530-534. doi: 10.1111/1759-7714.12361. Epub 2016 May 23.
Results Reference
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PubMed Identifier
19289625
Citation
Yan TD, Black D, Bannon PG, McCaughan BC. Systematic review and meta-analysis of randomized and nonrandomized trials on safety and efficacy of video-assisted thoracic surgery lobectomy for early-stage non-small-cell lung cancer. J Clin Oncol. 2009 May 20;27(15):2553-62. doi: 10.1200/JCO.2008.18.2733. Epub 2009 Mar 16.
Results Reference
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Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

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