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

Completed

• Conditions: Lung Cancer
• Interventions: Procedure: Robotic-assisted lobectomy using da Vinci Surgical System; Procedure: Open lobectomy; Procedure: VATS (video assisted thoracic surgery)

• Registration Number: NCT03347825
• Lead Sponsor: Intuitive Surgical

Brief 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

Study Timeline

• Study First Submitted: 2017-10-31
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-20
• Study Start: 2018-02-01
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7000

Inclusion Criteria

• Subject is 18 years or older
• Subject who has undergone elective robotic-assisted, VATS or open lobectomy for clinically diagnosed primary stage IA, IB, IIA, IIB and IIIA lung cancer, with or without neo-adjuvant therapy

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Exclusion Criteria

• Subject with stage IIIB lung cancer
• Subject who received lobectomy as an emergent procedure
• Subjects who received lobectomy for metastatic cancer

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robotic-assisted lobectomy	Robotic-assisted lobectomy using da Vinci Surgical System	Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent robotic-assisted lobectomy for lung cancer.
Open lobectomy	Open lobectomy	Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent open lobectomy for lung cancer.
VATS (video assisted thoracic surgery) lobectomy	VATS (video assisted thoracic surgery)	Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent VATS lobectomy for lung cancer.

Primary Outcome Measures

Name	Time	Method
Chart review and data collection of clinical stage IB, IIA, IIB, IIIA cases	2013-2019	Compare peri-operative outcomes of robotic-assisted lobectomy with those associated with VATS and open lobectomy for lung cancer

Trial Locations

Locations (1)

BaylorScott&White; 🇺🇸 Dallas, Texas, United States