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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 18, 2014