Assessment of Video Assisted Thoracoscopic Surgery (VATS) Versus Open Surgery for Patients Undergoing Lobectomy

This study has been terminated.
(Slow Enrollment)
Sponsor:
Information provided by:
Covidien
ClinicalTrials.gov Identifier:
NCT00912366
First received: June 1, 2009
Last updated: July 8, 2010
Last verified: July 2010
  Purpose

Assessment of VATS versus standard open surgery for treatment of non small cell lung cancer.


Condition Intervention
Non Small Cell Lung Cancer
Procedure: Lobectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Single Center, Observational Study Comparing the Safety and Efficacy of CVATS, HVATS and Open Surgery for Subjects Diagnosed With NSCLC Scheduled to Undergo a Lobectomy

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Assess hospital length of stay (LOS). [ Time Frame: 1 time point (discharge) ] [ Designated as safety issue: No ]
  • Pain Scale Evaluation [ Time Frame: 5 time points out to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess quality of life. [ Time Frame: 2 time points out to 6 months ] [ Designated as safety issue: No ]
  • Assess peri-operative and post-operative complications. [ Time Frame: 5 time points out to 6 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: May 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
VATS
Procedure: Lobectomy
Assessment of VATS versus open surgery.
Other Names:
  • CVATS
  • HVATS
Group B
Open Surgery
Procedure: Lobectomy
Assessment of VATS versus open surgery.
Other Names:
  • CVATS
  • HVATS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects referred for lobectomies at the hospital.

Criteria

Inclusion Criteria:

  • Subject must be 18 years of age or older.
  • Subject must have been clinically diagnosed with stage I to stage IIA non small cell lung cancer measuring and judged to be resectable.
  • Subject must be able to tolerate general anesthesia, and have cardiopulmonary reserve to tolerate a lobectomy

Exclusion Criteria:

  • Subject is pregnant (documented by pregnancy test) or breastfeeding.
  • Subject has other severe illnesses that would preclude surgery such as

    • Unstable angina
    • Myocardial Infarction within 3 months
    • Coronary Artery Bypass Graft Surgery
  • Subject has other active cancers
  • Subject is unable to comply with any of the following:

    • Study requirements
    • Give valid informed consent
    • Follow-up schedule
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912366

Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
Covidien
  More Information

No publications provided

Responsible Party: Denese Slowly, Covidien
ClinicalTrials.gov Identifier: NCT00912366     History of Changes
Other Study ID Numbers: AS08015
Study First Received: June 1, 2009
Last Updated: July 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
VATS
Lung cancer
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 14, 2014