Laparoscopic Versus Open Appendectomy? Let the Patient Decide

April 16, 2014 updated by: University of Utah

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cost Information Included
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
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Outcome assessed prior to surgical procedure with data presented within 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital/Operative Dollars
Time Frame: 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
Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Eric Scaife, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

November 22, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (ESTIMATE)

November 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UU56320

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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