Part vs Whole Task Mastery Training for Laparoscopic Hernia Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David R. Farley, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01629485
First received: June 25, 2012
Last updated: April 30, 2013
Last verified: April 2013

June 25, 2012
April 30, 2013
September 2011
May 2012   (final data collection date for primary outcome measure)
Operative Time [ Time Frame: Measured in Seconds ] [ Designated as safety issue: No ]
Operative Time will be measured with a chronometer. Staff take overs and down time will be excluded from the trainee's time. Trainee time will be defined as when he/she has the instruments in his/her hands and is actively doing the case.
Same as current
Complete list of historical versions of study NCT01629485 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Part vs Whole Task Mastery Training for Laparoscopic Hernia Repair
Part vs Whole Task Mastery Simulation Training for Laparoscopic Hernia Repair: A Randomized Trial

The investigators will perform a randomized controlled trial with a stratified-block design to compare the effect of the part versus whole task simulation training for TEP repairs.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Hernia
  • Behavioral: Online Video Curriculum
    A video curriculum has been designed for the purpose of educating general surgery residents in laparoscopic hernia repairs. The curriculum covers topics from basic anatomy, selection of patients, management, and operative technique.
  • Behavioral: Whole Task Mastery Training
    Trainees will undergo whole task mastery training in the TEP simulator. The benchmarks for mastery training in the setting of whole task tep repairs was established with performance measures of multiple staff surgeons previously.
  • Behavioral: Part Task Mastery Training
    Trainees will undergo part task mastery training in the TEP simulator. The benchmarks for mastery training in the setting of part task tep repairs was established with performance measures of multiple staff surgeons previously.
  • Experimental: Whole Task
    Trainees will undergo whole task mastery training in the TEP simulator after completing the video curriculum portion.
    Interventions:
    • Behavioral: Online Video Curriculum
    • Behavioral: Whole Task Mastery Training
  • Experimental: Part Task
    Trainees will undergo a random part task mastery training in the TEP simulator after completing the video portion of the curriculum.
    Interventions:
    • Behavioral: Online Video Curriculum
    • Behavioral: Part Task Mastery Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Study Participants: Only residents who have achieved mastery of the TEP training curriculum (in either arm) will be eligible for OR assessment
  • Patients: All patients deemed fit by the staff supervising surgeon to undergo a TEP repair will be considered for this study.
Both
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01629485
11-005712
No
David R. Farley, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Roberto Hernandez-Irizarry, BS Mayo Clinic
Principal Investigator: David Farley, MD Mayo Clinic
Principal Investigator: Benjamin Zendejas, MD/MsC Mayo Clinic
Mayo Clinic
April 2013

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