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Mastery Learning Inguinal Hernia Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085500
First Posted: March 12, 2010
Last Update Posted: October 28, 2016
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.
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
David R. Farley, Mayo Clinic
Results First Submitted: May 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor)
Condition: Inguinal Hernia
Interventions: Behavioral: Mastery Learning TEP Curriculum
Procedure: Current Practice

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
General surgery residents were recruited from the Mayo Clinic, Rochester, Minnesota from January to September 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Simulation Curriculum General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
Current Practice General surgery residents will undergo training according to current practice.

Participant Flow:   Overall Study
    Simulation Curriculum   Current Practice
STARTED   26   24 
COMPLETED   26   24 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Simulation Curriculum General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
Current Practice General surgery residents will undergo training according to current practice.
Total Total of all reporting groups

Baseline Measures
   Simulation Curriculum   Current Practice   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   24   50 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   26   24   50 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 30  (2)   30  (3)   30  (2) 
Gender 
[Units: Participants]
     
Female   9   6   15 
Male   17   18   35 
Region of Enrollment 
[Units: Participants]
     
United States   26   24   50 


  Outcome Measures
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1.  Primary:   Participation-Corrected Operative Time   [ Time Frame: at first TEP procedure post-randomization; Due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two ]

2.  Secondary:   Operative Performance   [ Time Frame: at first TEP procedure post-randomization; due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two ]

3.  Secondary:   Number of Hernia Repair Subjects With Post-Operative Urinary Retention   [ Time Frame: at first TEP procedure post-randomization, subjects were followed for the duration of hospital stay, an average of 1 night ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Benjamin Zendejas, MD
Organization: Mayo Clinic
phone: 507-538-5413
e-mail: zendejas.benjamin@mayo.edu


Publications of Results:

Responsible Party: David R. Farley, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01085500     History of Changes
Other Study ID Numbers: 09-008118
1UL1RR024150 ( U.S. NIH Grant/Contract )
First Submitted: March 10, 2010
First Posted: March 12, 2010
Results First Submitted: May 16, 2011
Results First Posted: June 10, 2011
Last Update Posted: October 28, 2016