Cost Effectiveness Analysis of Cholecystectomy, Projected Long Term Outcomes and Complications Evaluation (NOTES)
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|ClinicalTrials.gov Identifier: NCT01117415|
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : June 8, 2015
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||Cost Effectiveness Analysis of Transgastric Cholecystectomy, Transvaginal Cholecystectomy, and Laparoscopic Cholecystectomy: Projected Long Term Outcomes and Complications Evaluation|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Gall Bladder Surgery
Who have symptomatic cholelithiasis and wish to undergo laparoscopic cholecystectomy for treatment.
- Compare cost effectiveness data at one year postoperative [ Time Frame: 1 year ]One year cost effectiveness data comparing transgastric cholecystectomy, transvaginal cholecystectomy, and laparoscopic cholecystectomy. Costs from two national databases: the State Ambulatory Surgery Database (SASD) and the NIS. The main outcome measure for this study will be cost per quality adjusted life year (QALY). Markov modeling techniques for model patient experiences for each of the procedures analyzed. Monte Carlo simulation will be used to calculate cost per QALY over a one year time span with determination of the incremental cost effectiveness ratio.
- Analyze the important factor that contributes to cost effectiveness at one year post operative. [ Time Frame: One year ]Extensive sensitivity analyses of how individual factors (e.g. probability of gastric leak in transgastric cholecystectomy) impact cost effectiveness. Factors are varied over a clinically plausible range and their impact on cost effectiveness determined. One way and two way sensitivity analyses allow alterations of one or two factors simultaneously. Multiway sensitivity analysis using Monte Carlo simulation will be used to vary several variables simultaneously and to determine impact on cost effectiveness.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117415
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Benjamin K. Poulose, MD, MPH||University Hospitals Cleveland Medical Center|