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| Sponsored by: |
Department of Veterans Affairs |
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00013156 |
Purpose
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.
| Condition | Intervention | Phase |
|
Chronic Obstructive Pulmonary Disease Emphysema |
Procedure: Effectiveness of Lung Reduction Therapy |
Phase II |
| MedlinePlus related topics: | COPD (Chronic Obstructive Pulmonary Disease) Emphysema |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Cost-Effectiveness of Lung Volume Reduction Surgery |
| Estimated Enrollment: | 92 |
| Study Completion Date: | March 2000 |
| Arms | Assigned Interventions |
| 1 | Procedure: Effectiveness of Lung Reduction Therapy |
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.
Eligibility
| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations| United States, Vermont | |||||
| VA Medical & Regional Office Center, White River | |||||
| White River Junction, Vermont, United States, 05009-0001 | |||||
| United States, Washington | |||||
| VA Puget Sound Health Care System, Seattle | |||||
| Seattle, Washington, United States, 98101 | |||||
| Principal Investigator: | Hugh F. Huizenga, MD MPH | VA Medical & Regional Office Center, White River |
More Information
| Responsible Party: | Department of Veterans Affairs ( Huizenga, Hugh - Principal Investigator ) |
| Study ID Numbers: | IIR 96-024 |
| First Received: | March 14, 2001 |
| Last Updated: | August 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00013156 |
| Health Authority: | United States: Federal Government |
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