N/A
N=100
Laparoscopic Versus Open Appendectomy? Let the Patient Decide
Appendicitis
Bottom Line
View on ClinicalTrials.gov: NCT01738750 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Choice Based on Cost — 63; 35 percentage of open appendectomy
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cost Information Included (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Choice Based on Cost |
63; 35 | — |
| SECONDARY Hospital/Operative Dollars |
9,949; 10,477 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01738750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.