Mastery Learning Inguinal Hernia Repair

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01085500
First received: March 10, 2010
Last updated: February 21, 2012
Last verified: February 2012
Results First Received: May 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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  
Number of Participants  
[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
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  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, MD, Mayo Clinic, Rochester, MN
ClinicalTrials.gov Identifier: NCT01085500     History of Changes
Other Study ID Numbers: 09-008118, 1UL1RR024150
Study First Received: March 10, 2010
Results First Received: May 16, 2011
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board