Laparoscopic Versus Open Appendectomy? Let the Patient Decide

This study is currently recruiting participants.
Verified November 2012 by University of Utah
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01738750
First received: November 22, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Appendicitis
Other: Cost Information Included

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Laparoscopic Versus Open Appendectomy? Let the Patient Decide

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Choice Based on Cost [ Time Frame: Outcome assessed prior to surgical procedure with data presented within 1 year ] [ Designated as safety issue: No ]
    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:
  • Hospital/Operative Charges [ Time Frame: Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year ] [ Designated as safety issue: No ]
    A comparison of the overall hospital admission and operative charges for acute appendicitis and appendectomy between the two groups


Other Outcome Measures:
  • Reasons for Choice [ Time Frame: Data will be collected before patient discharge or within an average of 1 month post-discharge and data presented within 1 year ] [ Designated as safety issue: No ]
    Determination of the principal reason for choice of appendectomy surgical procedure


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738750

Locations
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Eric Scaife, MD    801-662-1000    eric.scaife@hsc.utah.edu   
Contact: Mary C Mone, RN BSE    801-581-4594    mary.mone@hsc.utah.edu   
Principal Investigator: Eric Scaife, MD         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Eric Scaife, MD University of Utah
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01738750     History of Changes
Other Study ID Numbers: UU56320
Study First Received: November 22, 2012
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
surgical choice
cost of care
decision making
health care
health care cost
pediatric
children
appendicitis
patient satisfaction

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014