Cost Effectiveness Analysis of Cholecystectomy, Projected Long Term Outcomes and Complications Evaluation

Cholelithiasis Clinical Trial

— NOTES  

Official title:

Cost Effectiveness Analysis of Transgastric Cholecystectomy, Transvaginal Cholecystectomy, and Laparoscopic Cholecystectomy: Projected Long Term Outcomes and Complications Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117415
• Other study ID #: 09-07-40
• Secondary ID: 09-07-40
• Status: Completed
• Phase: N/A
• First received: April 12, 2010
• Last updated: June 4, 2015
• Start date: April 2007
• Est. completion date: June 2010

Study information

• Verified date: June 2015
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Participation in this research study does not involve any procedures. Health preference will be ascertained through standard techniques including time-tradeoff, standard gamble, and rating scale to assess risks regarding potential complications specific to NOTES (Natural Orifice Translumenal Endoscopic Surgery)gallbladder removal.

Description:

The enticement of scarless surgery has created an unprecedented wave of enthusiasm and collaboration amongst surgeons, gastroenterologists, industry, and the lay public. However, major hurdles remain between current minimally invasive practices and the ultimate goal of safe, effective Natural Orifice Translumenal Endoscopic Surgery (NOTES). In an ideal world, these procedures should incur equivalent (or less) morbidity than current laparoscopic approaches and offer benefits of incisionless surgery. This idealism has been quickly tempered by the potential to create new and devastating complications with only minimal potential benefit to the patient. Several critical questions need to be answered. What probability of complication(s) are to be accepted? How will the potential benefits of NOTES be weighed against these new complications? What factors unique to NOTES will contribute to its cost effectiveness? The proposed study seeks to answer these questions before they occur. These results will give clinicians and investigators the necessary information with which to compare outcomes of NOTES and potentially alter techniques for safer, more effective interventions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Candidate of either sex

• 18 years old or above

• Have symptomatic cholelithiasis

• Wish to undergo laparoscopic cholecystectomy for treatment

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Case Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare cost effectiveness data at one year postoperative	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.	1 year	No
Secondary	Analyze the important factor that contributes to cost effectiveness at one year post operative.	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.	One year	No