Cost-Effectiveness of Lung Volume Reduction Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00013156
First received: March 14, 2001
Last updated: April 16, 2014
Last verified: April 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cost-Effectiveness of Lung Volume Reduction Surgery

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 92
Study Completion Date: March 2000
Arms Assigned Interventions
Arm 1 Procedure: Effectiveness of Lung Reduction Therapy

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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00013156

Locations
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Investigators
Principal Investigator: Hugh F Huizenga, MD MPH VA Medical & Regional Office Center, White River
Principal Investigator: Stephan D. Fihn, MD MPH VA Puget Sound Health Care System, Seattle
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00013156     History of Changes
Other Study ID Numbers: IIR 96-024
Study First Received: March 14, 2001
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014