Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2000-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Effectiveness of Lung Reduction Therapy
Interventions
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Effectiveness of Lung Reduction Therapy
Eligibility Criteria
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Inclusion Criteria
75 Years
MALE
No
Sponsors
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US Department of Veterans Affairs
FED
Responsible Party
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Principal Investigators
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Hugh F Huizenga, MD MPH
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Stephan D. Fihn, MD MPH
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Locations
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VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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IIR 96-024
Identifier Type: -
Identifier Source: org_study_id
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