NCT03347825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

2.4 years

First QC Date

October 31, 2017

Last Update Submit

February 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chart review and data collection of clinical stage IB, IIA, IIB, IIIA cases

    Compare peri-operative outcomes of robotic-assisted lobectomy with those associated with VATS and open lobectomy for lung cancer

    2013-2019

Study Arms (3)

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.

Procedure: Robotic-assisted lobectomy using da Vinci Surgical System

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.

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.

Procedure: Open lobectomy

Interventions

Robotic-assisted lobectomy

Robotic-assisted lobectomy

VATS (video assisted thoracic surgery)

VATS (video assisted thoracic surgery) lobectomy

Open lobectomy

Open lobectomy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent robotic-assisted, VATS or open lobectomy for primary stage IA, IB, IIA, IIB and IIIA lung cancer, with or without neo-adjuvant therapy.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BaylorScott&White

Dallas, Texas, 75093, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThoracoscopyEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisVideo-Assisted SurgeryMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 20, 2017

Study Start

February 1, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

February 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations