Laparoscopic Versus Open Appendectomy? Let the Patient Decide
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|ClinicalTrials.gov Identifier: NCT01738750|
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : May 19, 2014
Last Update Posted : May 19, 2014
This protocol examines choice where it pertains to choosing between two standard methods for appendectomy, laparoscopic or open procedures, and the affect that "cost" of the appendectomy has upon choice.
Children admitted with a diagnosis of uncomplicated appendicitis will be consented to participate in a study in which the patient can choose between laparoscopic or open appendectomy procedures. Those that agree to review a consent form will be randomly placed into one of two groups. The two groups consist of one in which the consent form includes "cost information for each operative procedure" in the comparison between the procedures, and the other group receives a consent form that does not include "cost information for each operative procedure". Both groups also view a short, group specific, computerized presentation that describes each procedure.
The hypothesis is that those patients given a choice between two similar surgical procedures and are provided with "cost information" will more often choose the less expensive surgical procedure than those that do not have information related to the cost of the surgical procedures.
|Condition or disease||Intervention/treatment||Phase|
|Appendicitis||Other: Cost Information Included||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Laparoscopic Versus Open Appendectomy? Let the Patient Decide|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Cost Information Included
Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.
|Other: Cost Information Included|
No Intervention: No Cost Information Included
Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
- Choice Based on Cost [ Time Frame: Outcome assessed prior to surgical procedure with data presented within 1 year ]The group given information related to the cost of each surgical procedure will more often choose the less expensive procedure as compared to those not given cost information
- Hospital/Operative Dollars [ Time Frame: Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year ]A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups
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): NCT01738750
|United States, Utah|
|Primary Children's Hospital|
|Salt Lake City, Utah, United States, 84113|
|Principal Investigator:||Eric Scaife, MD||University of Utah|