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出境医 / 临床实验 / Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

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 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.

Study Design
Layout table for study information
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
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. 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.


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Locations
Layout table for location information
Italy
Policlinico Tor Vergata University
Roma, Italy, 00133
Sponsors and Collaborators
University of Rome Tor Vergata
Investigators
Layout table for investigator information
Principal Investigator: Eugenio Pompeo, MD Tor Vergata University
Tracking Information
First Submitted Date  ICMJE February 27, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date April 8, 2020
Actual Study Start Date  ICMJE October 1, 2018
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2019) 		a difference ≥10% in the score calculated for at least one ergonomical domain including exposure, instrumentation and maneuvering. [ Time Frame: one week after surgery ]
3 ergonomical domains: exposure, instrumentation and maneuvering are assessed by 3 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2019)
  • Operative time [ Time Frame: during surgery ]
    Total duration (min) of the surgical procedure from first incision opening to last incision closure
  • intraoperative bleeding [ Time Frame: intraoperative ]
    Total amount of blood (mL) lost during the surgical procedure
  • postoperative drainage volume [ Time Frame: two weeks after surgery ]
    Total amount of fluid (mL) collected through the chest drain during in-hospital stay
  • surgical mortality [ Time Frame: 90 days after surgery ]
    Fatal complications occurryng within 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
  • hospital stay [ Time Frame: 30 days after surgery ]
    Overall duration (days) of in-hospital stay after the surgical procedure
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2019)
  • Operative time [ Time Frame: during surgery ]
    Total duration (min) of the surgical procedure from first incision opening to last incision closure
  • intraoperative bleeding [ Time Frame: intraoperative ]
    Total amount of blood (mL) lost during the surgical procedure
  • postoperative drainage volume [ Time Frame: two weeks after surgery ]
    Total amount of fluid (mL) collected through the chest drain during in-hospital stay
  • surgical mortality [ Time Frame: 90 days after surgery ]
    Fatal complications occurryng within 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
  • hospital stay [ Time Frame: 30 days after surgery ]
    Overall duration (days) of in-hospital stay after the surgical procedure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy
Official Title  ICMJE Ergonomical Assessment of Three-Dimensional Versus Two-Dimensional Thoracoscopic Lobectomy for Lung Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
One to one parallel assignment to each treatment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Early Stage Non-small-cell Lung Cancer (Stage 1-2)
Intervention  ICMJE
  • Procedure: 3D VATS lobectomy
    pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 3 dimensional display system
  • Procedure: 2D VATS lobectomy
    pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 2 dimensional display system
Study Arms  ICMJE
  • Experimental: 3D VATS lobectomy
    Patients undergo thoracoscopic lobectomy by a three-dimensional display system
    Intervention: Procedure: 3D VATS lobectomy
  • Active Comparator: 2D VATS lobectomy
    Patients undergo thoracoscopic lobectomy by a two-dimensional display system
    Intervention: Procedure: 2D VATS lobectomy
Publications *
  • 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.
  • 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.
  • 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. Review.
  • 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 †. Interact Cardiovasc Thorac Surg. 2015 Jun;20(6):820-3. doi: 10.1093/icvts/ivv031. Epub 2015 Mar 3.
  • 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.
  • 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.
  • 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2019) 		70
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2019) 		60
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03925103
Other Study ID Numbers  ICMJE 2019-1RT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eugenio Pompeo, University of Rome Tor Vergata
Study Sponsor  ICMJE University of Rome Tor Vergata
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eugenio Pompeo, MD Tor Vergata University
PRS Account University of Rome Tor Vergata
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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