Laparoscopic Versus Open Appendectomy? Let the Patient Decide
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Choice Based on Cost
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •acute appendicitis
Exclusion Criteria
- •age 18 or older
- •imaging positive for perforation; ultrasound or CT scan
- •pain for greater than 2 days
- •children with a body mass index > 95% for age and sex
- •surgeon decision for non-equivalent procedure based on patient presentation
Arms & Interventions
Cost Information Included
Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.
Intervention: Cost Information Included (Other)
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Hospital/Operative Dollars(Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year)