NCT03347825

Retrospective Multi-Center Study to Compare Perioperative Outcomes for Robotic-assisted Lobectomy With Those Associated With VATS and Open Lobectomy for Lung Cancer

A Retrospective Multi-Center Study for Evaluation of Clinical Outcomes With Lobectomy for Lung Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7,000 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The main objective of this study is to evaluate and compare peri-operative outcomes of lobectomy compare with different approaches. The study aims to include patients with stage IA, IB, IIA, IIB and IIIA lung cancer that underwent lobectomy via robotic-assisted, VATS and open approach.

Detailed description

This is a multi-center, retrospective chart review study of all consecutive lobectomies performed for clinical stage IA, IB, IIA, IIB and IIIA lung cancer, performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. All cases of lobectomy performed for clinical stages, IA, IB, IIA, IIB and IIIA lung cancer via robotic-assisted, VATS (video assisted thoracic surgery) and open approach that meet the study inclusion and exclusion criteria will be considered for inclusion in the study. The chart review and data collection will be performed in a reverse chronological order starting at 30 days prior to IRB approval of the study at the institution and going back to 2013 (i.e most current data in 2017 and chronologically going back through 2013). The retrospective chart review and data collection is anticipated to occur in two phases: Baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes data will be obtained from hospital records. Each participating institution will contribute approximately 100-800 cases from one or more surgeons. Since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment and no patient consenting is required

Conditions

• Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	Robotic-assisted lobectomy using da Vinci Surgical System	Robotic-assisted lobectomy
PROCEDURE	VATS (video assisted thoracic surgery)	VATS (video assisted thoracic surgery)
PROCEDURE	Open lobectomy	Open lobectomy

Timeline

• Start date: 2018-02-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2017-11-20
• Last updated: 2021-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study