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

NCT ID: NCT03347825

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-07-01

Brief Summary

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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

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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

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Robotic-assisted lobectomy

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.

Robotic-assisted lobectomy using da Vinci Surgical System

Intervention Type PROCEDURE

Robotic-assisted lobectomy

VATS (video assisted thoracic surgery) lobectomy

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.

VATS (video assisted thoracic surgery)

Intervention Type PROCEDURE

VATS (video assisted thoracic surgery)

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.

Open lobectomy

Intervention Type PROCEDURE

Open lobectomy

Interventions

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Robotic-assisted lobectomy using da Vinci Surgical System

Robotic-assisted lobectomy

Intervention Type PROCEDURE

VATS (video assisted thoracic surgery)

VATS (video assisted thoracic surgery)

Intervention Type PROCEDURE

Open lobectomy

Open lobectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Exclusion Criteria

* Subject with stage IIIB lung cancer
* Subject who received lobectomy as an emergent procedure
* Subjects who received lobectomy for metastatic cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intuitive Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BaylorScott&White

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ISI-dVLob-001

Identifier Type: -

Identifier Source: org_study_id

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