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Completed

NCT Number: NCT01117415

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not Applicable

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

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

Acronym: NOTES

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 5, 2010
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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