Cost-Effectiveness of Lung Volume Reduction Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

March 14, 2001

Last Updated Date

October 31, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00013156 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Cost-Effectiveness of Lung Volume Reduction Surgery

Official Title ^ICMJE

Cost-Effectiveness of Lung Volume Reduction Surgery

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:

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease
Emphysema

Intervention ^ICMJE

Procedure: Effectiveness of Lung Reduction Therapy

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

March 2000

Primary Completion Date

Eligibility Criteria ^ICMJE

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:

Gender

Male

Ages

up to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00013156

Responsible Party

Huizenga, Hugh - Principal Investigator, Department of Veterans Affairs

Study ID Numbers ^ICMJE

IIR 96-024

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Hugh F. Huizenga, MD MPH

VA Medical & Regional Office Center, White River

Information Provided By

Department of Veterans Affairs

Verification Date

March 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP