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Laparoscopic Versus Open Appendectomy? Let the Patient Decide

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01738750
First Posted: November 30, 2012
Last Update Posted: May 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Utah
  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: None (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 ]
    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 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


Enrollment: 100
Study Start Date: July 2012
Study Completion Date: December 2013
Primary Completion Date: December 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738750


Locations
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Eric Scaife, MD University of Utah
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01738750     History of Changes
Other Study ID Numbers: UU56320
First Submitted: November 22, 2012
First Posted: November 30, 2012
Results First Submitted: January 8, 2014
Results First Posted: May 19, 2014
Last Update Posted: May 19, 2014
Last Verified: April 2014

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
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases