Laparoscopic Versus Open Appendectomy? Let the Patient Decide

Study Overview
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Brief Summary
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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.

Official Title
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Laparoscopic Versus Open Appendectomy? Let the Patient Decide

Conditions
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Appendicitis

Intervention / Treatment
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* Other: Cost Information Included


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cost Information Included<br>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<br> <br> |
| No Intervention: No Cost Information Included<br>Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choice Based on Cost | 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 | Outcome assessed prior to surgical procedure with data presented within 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital/Operative Dollars | A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups | Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical choice, cost of care, decision making, health care, health care cost, pediatric, children, appendicitis, patient satisfaction