Laparoscopic Versus Open Appendectomy? Let the Patient Decide
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Laparoscopic Versus Open Appendectomy? Let the Patient Decide|
- Choice Based on Cost [ Time Frame: Outcome assessed prior to surgical procedure with data presented within 1 year ] [ Designated as safety issue: No ]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 Charges [ Time Frame: Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year ] [ Designated as safety issue: No ]A comparison of the overall hospital admission and operative charges for acute appendicitis and appendectomy between the two groups
- Reasons for Choice [ Time Frame: Data will be collected before patient discharge or within an average of 1 month post-discharge and data presented within 1 year ] [ Designated as safety issue: No ]Determination of the principal reason for choice of appendectomy surgical procedure
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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.
|United States, Utah|
|Primary Children's Hospital||Recruiting|
|Salt Lake City, Utah, United States, 84113|
|Contact: Eric Scaife, MD 801-662-1000 firstname.lastname@example.org|
|Contact: Mary C Mone, RN BSE 801-581-4594 email@example.com|
|Principal Investigator: Eric Scaife, MD|
|Principal Investigator:||Eric Scaife, MD||University of Utah|