Laparoscopic Versus Open Appendectomy? Let the Patient Decide

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.

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Key information

Conditions

Appendicitis Behavior Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Health Behavior Infections Intestinal Diseases Intraabdominal Infections Patient Satisfaction Treatment Adherence and Compliance

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cost Information Included

Other

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

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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Nov 30, 2012
Registry last updated: May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed