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Cost-Effectiveness of Lung Volume Reduction Surgery



Cost-Effectiveness of Lung Volume Reduction Surgery

For Condition: Emphysema,Chronic Obstructive Pulmonary Disease
Status: Completed
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Health Services Research and Development Service
Synopsis: 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. Evaluate cost-effectiveness of LVRS compared to current therapy for COPD. 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Male
Protocol Entry 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
Total Enrollment: 92

Location and Contact Information:

VA Medical & Regional Office Center
White River Junction,  Vermont,  05009-0001
United States
 

Seattle Medical Center
Seattle,  Washington,  98108
United States
 


Additional Information:
Study ID Numbers:
  IIR 96-024; 
Study Start Date: October 1997
Record last reviewed: October 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00013156

Other Emphysema Studies:
1. OPUS Study: Effect of Roflumilast on exacerbation rate in patients with chronic obstructive pulmonary disease

2. Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects with COPD

3. Nocturnal Oxygen Therapy

4. Chronic Obstructive Pulmonary Disease Gene Localization

5. Lay-Led Smoking Cessation Approach for Southeast Asian Men

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