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Laparoscopic Versus Open Appendectomy? Let the Patient Decide

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.
 
ClinicalTrials.gov Identifier: NCT01738750
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : May 19, 2014
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
University of Utah

Tracking Information
First Submitted Date  ICMJE November 22, 2012
First Posted Date  ICMJE November 30, 2012
Results First Submitted Date  ICMJE January 8, 2014
Results First Posted Date  ICMJE May 19, 2014
Last Update Posted Date May 19, 2014
Study Start Date  ICMJE July 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2012)
Hospital/Operative Charges [ 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 charges for acute appendicitis and appendectomy between the two groups
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 27, 2012)
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 ]
Determination of the principal reason for choice of appendectomy surgical procedure
 
Descriptive Information
Brief Title  ICMJE Laparoscopic Versus Open Appendectomy? Let the Patient Decide
Official Title  ICMJE Laparoscopic Versus Open Appendectomy? Let the Patient Decide
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Appendicitis
Intervention  ICMJE Other: Cost Information Included
Study Arms  ICMJE
  • 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.
    Intervention: 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.
Publications * Russell KW, Rollins MD, Barnhart DC, Mone MC, Meyers RL, Skarda DE, Soukup ES, Black RE, Molitor MS, Stoddard GJ, Scaife ER. Charge Awareness Affects Treatment Choice: Prospective Randomized Trial in Pediatric Appendectomy. Ann Surg. 2015 Jul;262(1):189-93. doi: 10.1097/SLA.0000000000000885.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01738750
Other Study ID Numbers  ICMJE UU56320
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Scaife, MD University of Utah
PRS Account University of Utah
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP