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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D VATS lobectomy | Experimental | Patients undergo thoracoscopic lobectomy by a three-dimensional display system |
|
| 2D VATS lobectomy | Active Comparator | Patients undergo thoracoscopic lobectomy by a two-dimensional display system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D VATS lobectomy | Procedure | pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 3 dimensional display system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Total duration (min) of the surgical procedure from first incision opening to last incision closure | during surgery |
| intraoperative bleeding | Total amount of blood (mL) lost during the surgical procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugenio Pompeo, MD | Tor Vergata University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Tor Vergata University | Roma | 00133 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20172539 | Background | 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. | |
| 19619789 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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One to one parallel assignment to each treatment
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| 2D VATS lobectomy | Procedure | pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 2 dimensional display system |
|
| intraoperative |
| postoperative drainage volume | Total amount of fluid (mL) collected through the chest drain during in-hospital stay | two weeks after surgery |
| surgical mortality | Fatal complications occurryng within 90 days after surgery | 90 days after surgery |
| complications | Any adverse event recorded perioperatively or after the surgical procedure during in-hospital stay | 30 days after surgery |
| hospital stay | 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. | 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. | 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 |
| Background |
| 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. |
| 29049786 | Background | 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. |
| 25736286 | Background | 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. |
| 27755803 | Background | 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. |
| 27766782 | Background | 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. |
| 19289625 | Background | 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. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |