Part vs Whole Task Mastery Training for Laparoscopic Hernia Repair

Hernia Clinical Trial

Official title:

Part vs Whole Task Mastery Simulation Training for Laparoscopic Hernia Repair: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629485
• Other study ID #: 11-005712
• Status: Completed
• Phase: N/A
• First received: June 25, 2012
• Last updated: April 30, 2013
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: April 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No