Cost-Effectiveness of Lung Volume Reduction Surgery
Primary Purpose
Chronic Obstructive Pulmonary Disease, Emphysema
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Effectiveness of Lung Reduction Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria: Severe COPD as defined by FEV1 of 20-30% predicted; marked hyperinflation with a residual volume of >165% predicted; 6-min walk greater than 600 ft; abstinence from cigarette smoking for 3-mths; absence of co-morbid illnesses that would significantly increase surgical risk, such as severe coronary artery disease Exclusion Criteria:
Sites / Locations
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00013156
First Posted
March 14, 2001
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00013156
Brief Title
Cost-Effectiveness of Lung Volume Reduction Surgery
Official Title
Cost-Effectiveness of Lung Volume Reduction Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2000 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Lung volume reduction surgery (LVRS) has been advanced as a therapy to significantly improve quality of life in patients with COPD, but to date no controlled studies have evaluated the impact of LVRS.
Detailed Description
Background:
Lung volume reduction surgery (LVRS) has been advanced as a therapy to significantly improve quality of life in patients with COPD, but to date no controlled studies have evaluated the impact of LVRS.
Objectives:
Evaluate cost-effectiveness of LVRS compared to current therapy for COPD.
Methods:
This is a case control study in which veterans undergoing LVRS at VA Puget Sound Health Care System (VAPSHCS) are compared to patients with a similar severity of disease at Boise VAMC who are not undergoing LVRS. Changes in health related quality of life are being evaluated using three instruments: the SF-36, the St. George�s Respiratory Questionnaire, and the Quality of Well-Being Scale, the latter to calculate utility associated with different health states. Costs will be determined using utilization data on outpatient visits, medications, oxygen use, inpatient days, radiology tests, laboratory tests, and emergency room visits are being collected for the twelve months before and after surgery. Costs will be calculated according to VA and community standards.
Status:
Complete.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Emphysema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Effectiveness of Lung Reduction Therapy
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe COPD as defined by FEV1 of 20-30% predicted; marked hyperinflation with a residual volume of >165% predicted; 6-min walk greater than 600 ft; abstinence from cigarette smoking for 3-mths; absence of co-morbid illnesses that would significantly increase surgical risk, such as severe coronary artery disease
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh F Huizenga, MD MPH
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephan D. Fihn, MD MPH
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9872192
Citation
Huizenga HF, Ramsey SD, Albert RK. Estimated growth of lung volume reduction surgery among Medicare enrollees: 1994 to 1996. Chest. 1998 Dec;114(6):1583-7. doi: 10.1378/chest.114.6.1583.
Results Reference
result
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Cost-Effectiveness of Lung Volume Reduction Surgery
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