Part vs Whole Task Mastery Training for Laparoscopic Hernia Repair
Part vs Whole Task Mastery Simulation Training for Laparoscopic Hernia Repair: A Randomized Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 25, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2012
CompletedMay 1, 2013
April 1, 2013
8 months
June 25, 2012
April 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Operative Time
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.
Measured in Seconds
Study Arms (2)
Whole Task
EXPERIMENTALTrainees will undergo whole task mastery training in the TEP simulator after completing the video curriculum portion.
Part Task
EXPERIMENTALTrainees will undergo a random part task mastery training in the TEP simulator after completing the video portion of the curriculum.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roberto Hernandez-Irizarry, BS
Mayo Clinic
- PRINCIPAL INVESTIGATOR
David Farley, MD
Mayo Clinic
- PRINCIPAL INVESTIGATOR
Benjamin Zendejas, MD/MsC
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Director of the Mayo Simulation Center, Professor of Surgery
Study Record Dates
First Submitted
June 25, 2012
First Posted
June 27, 2012
Study Start
September 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
May 1, 2013
Record last verified: 2013-04