Laparoscopic Versus Open Appendectomy? Let the Patient Decide

Appendicitis Clinical Trial

Official title:

Laparoscopic Versus Open Appendectomy? Let the Patient Decide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738750
• Other study ID #: UU56320
• Status: Completed
• Phase: N/A
• First received: November 22, 2012
• Last updated: April 16, 2014
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Appendicitis

Intervention

Other:
• Cost Information Included

Locations

Country	Name	City	State
United States	Primary Children's Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No