Laparoscopic Versus Open Appendectomy? Let the Patient Decide

Not Applicable

Completed

• Conditions: Appendicitis
• Interventions: Other: Cost Information Included

• Registration Number: NCT01738750
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-30
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2014-01-08
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-16
• Last Update Submitted: 2014-04-16
• Results First Posted: 2014-05-19
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• acute appendicitis

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cost Information Included	Cost Information Included	Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.

Primary Outcome Measures

Name	Time	Method
Choice Based on Cost	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 Outcome Measures

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

Trial Locations

Locations (1)

Primary Children's Hospital; 🇺🇸 Salt Lake City, Utah, United States