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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Appendicitis
Intervention Other: Cost Information Included
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cost Information Included No Cost Information Included
Hide Arm/Group Description

Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.

Cost Information Included

Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
Period Title: Overall Study
Started 49 51
Completed 49 51
Not Completed 0 0
Arm/Group Title Cost Information Included No Cost Information Included Total
Hide Arm/Group Description

Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.

Cost Information Included

Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure. Total of all reporting groups
Overall Number of Baseline Participants 49 51 100
Hide Baseline Analysis Population Description
Age, Gender
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 51 participants 100 participants
10.8  (3.3) 10.6  (3.2) 10.7  (3.2)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 100 participants
<=18 years
49
 100.0%
51
 100.0%
100
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 100 participants
Female
22
  44.9%
20
  39.2%
42
  42.0%
Male
27
  55.1%
31
  60.8%
58
  58.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants 51 participants 100 participants
49 51 100
1.Primary Outcome
Title Choice Based on Cost
Hide Description 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
Time Frame Outcome assessed prior to surgical procedure with data presented within 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cost Information Included No Cost Information Included
Hide Arm/Group Description:
Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy
Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy
Overall Number of Participants Analyzed 49 51
Measure Type: Number
Unit of Measure: percentage of open appendectomy
63 35
2.Secondary Outcome
Title Hospital/Operative Dollars
Hide Description A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups
Time Frame Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dollar Information Included No Dollar Information Included
Hide Arm/Group Description:

Group of patients that will receive dollars information for both the laparoscopic and open surgical procedures prior to choice of procedure.

Dollars Information Included

Group of patients that will not receive dollar information for the laparoscopic and open surgical procedures prior to choice of procedure.
Overall Number of Participants Analyzed 49 51
Median (Inter-Quartile Range)
Unit of Measure: Dollar
9,949
(8,601 to 11,338)
10,477
(9,213 to 11,972)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cost Information Included No Cost Information Included
Hide Arm/Group Description

Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.

Cost Information Included

Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
All-Cause Mortality
Cost Information Included No Cost Information Included
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cost Information Included No Cost Information Included
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/51 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cost Information Included No Cost Information Included
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/51 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Eric Scaife
Organization: University of Utah
Phone: 801-662-2950
EMail: eric.scaife@imail2.org
Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01738750    
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