Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03347825
Acronym
PORTaL
Enrollment
7000
Registered
2017-11-20
Start date
2018-02-01
Completion date
2020-07-01
Last updated
2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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

Interventions

Open lobectomy

PROCEDURERobotic-assisted lobectomy using da Vinci Surgical System

Robotic-assisted lobectomy

PROCEDUREVATS (video assisted thoracic surgery)

VATS (video assisted thoracic surgery)

Sponsors

Intuitive Surgical
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Chart review and data collection of clinical stage IB, IIA, IIB, IIIA cases2013-2019Compare peri-operative outcomes of robotic-assisted lobectomy with those associated with VATS and open lobectomy for lung cancer

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026