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

NCT01117415 | Completed DMC

• 1 other identifier: 09-07-40
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholelithiasis

Keywords

Gall Bladder; Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Analyze the important factor that contributes to cost effectiveness at one year post operative.

  One year

Study Arms (1)

Gall Bladder Surgery

Who have symptomatic cholelithiasis and wish to undergo laparoscopic cholecystectomy for treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited from the University Hospitals Case Medical Center Department of Surgery. The patient population in this study for the visual analog scale measurement, standard gamble questionnaire, and time trade-off questionnaire will be candidates of either sex, 18 years old or above, who have symptomatic cholelithiasis and wish to undergo laparoscopic cholecystectomy for treatment. The patients will be asked to participate in the study after evaluation by either the principal investigator, co-investigators, or study coordinator. The investigator will discuss the study with the patient and the study coordinator will participate in reviewing details and questions regarding the study if necessary. Patients will be recruited until 40 participants are enrolled.

You may qualify if:

• Candidate of either sex
• years old or above
• Have symptomatic cholelithiasis
• Wish to undergo laparoscopic cholecystectomy for treatment

You may not qualify if:

• Not Applicable

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Benjamin K. Poulose, MD, MPH

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: May 5, 2010
• Study Start: April 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

US (1)