- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03925103
Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy
Ergonomical Assessment of Three-Dimensional Versus Two-Dimensional Thoracoscopic Lobectomy for Lung Cancer
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.
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Roma, Italy, 00133
- Policlinico Tor Vergata University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3D VATS lobectomy
Patients undergo thoracoscopic lobectomy by a three-dimensional display system
|
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
|
pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 2 dimensional display system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one week after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative time
Time Frame: during surgery
|
Total duration (min) of the surgical procedure from first incision opening to last incision closure
|
during surgery
|
intraoperative bleeding
Time Frame: intraoperative
|
Total amount of blood (mL) lost during the surgical procedure
|
intraoperative
|
postoperative drainage volume
Time Frame: two weeks after surgery
|
Total amount of fluid (mL) collected through the chest drain during in-hospital stay
|
two weeks after surgery
|
surgical mortality
Time Frame: 90 days after surgery
|
Fatal complications occurryng within 90 days after surgery
|
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
|
30 days after surgery
|
hospital stay
Time Frame: 30 days after surgery
|
Overall duration (days) of in-hospital stay after the surgical procedure
|
30 days after surgery
|
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.
|
one week after surgery
|
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.
|
one week after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eugenio Pompeo, MD, Tor Vergata University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-1RT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Early Stage Non-small-cell Lung Cancer (Stage 1-2)
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung Carcinoma | Non-Squamous Non-Small...United States
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedTobacco Use Disorder | Stage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB...United States
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH); RefleXion...CompletedStage IB Non-Small Cell Lung Carcinoma AJCC v7 | Stage II Non-Small Cell Lung Cancer AJCC v7 | Stage IIA Non-Small Cell Lung Carcinoma AJCC v7 | Stage IIB Non-Small Cell Lung Carcinoma AJCC v7 | Stage I Lung Cancer | Stage II Lung Cancer | Stage I Non-Small Cell Lung Cancer AJCC v7 | Stage IA Non-Small...United States
-
Peking UniversityMerck Sharp & Dohme LLC; Cancer Institute and Hospital, Chinese Academy of... and other collaboratorsRecruitingStage IIIA Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung Cancer | Stage IIIB(N2) Non-small Cell Lung CancerChina
Clinical Trials on 3D VATS lobectomy
-
Ruijin HospitalCompleted
-
Tang-Du HospitalLinkDoc Technology (Beijing) Co. Ltd.CompletedNon-small Cell Lung CancerChina
-
Radboud University Medical CenterUniversity Medical Center NijmegenUnknown
-
Peking University People's HospitalPeking University; Sun Yat-sen University; Beijing Friendship Hospital; Shanghai... and other collaboratorsUnknown
-
University Hospital of FerraraCompletedThoracic Surgery, Video-Assisted
-
Università degli Studi dell'InsubriaCompletedLung Cancer | Surgery--Complications | Morality
-
University of BristolUniversity of Oxford; Royal Brompton & Harefield NHS Foundation TrustCompletedLung NeoplasmsUnited Kingdom
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Completed
-
Centre hospitalier de l'Université de Montréal...Active, not recruiting
-
Intuitive SurgicalCompleted