Retrospective Multi-Center Study to Compare Perioperative Outcomes for Robotic-assisted Lobectomy With Those Associated With VATS and Open Lobectomy for Lung Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | February 1, 2018 |
End Date: | May 1, 2019 |
A Retrospective Multi-Center Study for Evaluation of Clinical Outcomes With Lobectomy for Lung Cancer
The main objective of this study is to compare perioperative outcomes for robotic-assisted
lobectomy with those associated with VATS and open lobectomy for lung cancer
lobectomy with those associated with VATS and open lobectomy for lung cancer
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:
Phase-I: Phase I will include chart review and data collection of clinical stage IB, IIA,
IIB, IIIA cases from approximately 30-days prior to IRB approval of the study in 2017 or
early 2018 and will continue retrospectively thru January 1, 2013 at each institution.
Phase-II: This phase will be initiated after completion of phase-I at each institution and
will include chart review and data collection of clinical stage IA cases from approximately
30-days prior to IRB approval of the study in 2017 or early 2018 and will continue
retrospectively thru January 1, 2013 at each institution.
Depending on availability of research coordinator resource (s) at each institution, the
institution can choose to complete the data collection of both the phases either
simultaneously or sequentially.
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
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:
Phase-I: Phase I will include chart review and data collection of clinical stage IB, IIA,
IIB, IIIA cases from approximately 30-days prior to IRB approval of the study in 2017 or
early 2018 and will continue retrospectively thru January 1, 2013 at each institution.
Phase-II: This phase will be initiated after completion of phase-I at each institution and
will include chart review and data collection of clinical stage IA cases from approximately
30-days prior to IRB approval of the study in 2017 or early 2018 and will continue
retrospectively thru January 1, 2013 at each institution.
Depending on availability of research coordinator resource (s) at each institution, the
institution can choose to complete the data collection of both the phases either
simultaneously or sequentially.
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
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
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