Cost Effectiveness Analysis of Cholecystectomy, Projected Long Term Outcomes and Complications Evaluation (NOTES)
This study has been completed.
First Posted: May 5, 2010
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Information provided by (Responsible Party):
Jeffrey Marks, MD, University Hospital Case Medical Center
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||Cost Effectiveness Analysis of Transgastric Cholecystectomy, Transvaginal Cholecystectomy, and Laparoscopic Cholecystectomy: Projected Long Term Outcomes and Complications Evaluation
Primary Outcome Measures:
- 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 Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2010 (Final data collection date for primary outcome measure)
Gall Bladder Surgery
Who have symptomatic cholelithiasis and wish to undergo laparoscopic cholecystectomy for treatment.
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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Candidate of either sex
- 18 years old or above
- Have symptomatic cholelithiasis
- Wish to undergo laparoscopic cholecystectomy for treatment
Information from the National Library of Medicine
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
|University Hospitals Case Medical Center
|Cleveland, Ohio, United States, 44106 |
University Hospitals Cleveland Medical Center
||Benjamin K. Poulose, MD, MPH
||University Hospitals Cleveland Medical Center
||Jeffrey Marks, MD, Principal Investigator, University Hospital Case Medical Center
History of Changes
|Other Study ID Numbers:
09-07-40 ( Other Identifier: University Hospital case Medical Center )
||April 12, 2010
||May 5, 2010
|Last Update Posted:
||June 8, 2015
Keywords provided by Jeffrey Marks, MD, University Hospital Case Medical Center:
Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical