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Clinical Trials/NCT01738750
NCT01738750
Completed
Not Applicable

Laparoscopic Versus Open Appendectomy? Let the Patient Decide

University of Utah1 site in 1 country100 target enrollmentJuly 2012
ConditionsAppendicitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Appendicitis
Sponsor
University of Utah
Enrollment
100
Locations
1
Primary Endpoint
Choice Based on Cost
Status
Completed
Last Updated
11 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
December 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

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)

Study Sites (1)

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