Cost-Effectiveness of Lung Volume Reduction Surgery

Phase 2

Completed

• Conditions: Emphysema; Chronic Obstructive Pulmonary Disease
• Interventions: Procedure: Effectiveness of Lung Reduction Therapy

• Registration Number: NCT00013156
• Lead Sponsor: US Department of Veterans Affairs

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.

Study Timeline

• Study Completion: 2000-03
• Study First Submitted: 2001-03-14
• Study First Submitted QC: 2001-03-15
• Study First Posted: 2001-03-16
• Status Verified: 2007-02
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 92

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Effectiveness of Lung Reduction Therapy	-

Trial Locations

Locations (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States