Part vs Whole Task Mastery Training for Laparoscopic Hernia Repair

April 30, 2013 updated by: David R. Farley, Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole Task
Trainees will undergo whole task mastery training in the TEP simulator after completing the video curriculum portion.
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.
Experimental: Part Task
Trainees will undergo a random part task mastery training in the TEP simulator after completing the video portion of the curriculum.
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative Time
Time Frame: Measured in Seconds
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Roberto Hernandez-Irizarry, BS, Mayo Clinic
  • Principal Investigator: David Farley, MD, Mayo Clinic
  • Principal Investigator: Benjamin Zendejas, MD/MsC, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (Estimate)

June 27, 2012

Study Record Updates

Last Update Posted (Estimate)

May 1, 2013

Last Update Submitted That Met QC Criteria

April 30, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-005712

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hernia

Clinical Trials on Online Video Curriculum

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe