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Mastery Learning Inguinal Hernia Repair

NCT01085500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-10-28

Study results available
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Summary

Abstract: Minimally invasive techniques are now ubiquitous in the management of surgical disease. Competence in laparoscopy requires specialized training and practice. With the decrease of resident work hours, training programs need to explore and adopt efficient strategies to teach and evaluate laparoscopic skills. For economic, ethical, and legal considerations, the operating room may no longer be the ideal environment for teaching these basic technical skills. There appears to be a role for simulation in response to this need. The transfer of laparoscopic skills learned in a simulated environment to the operating room has showed mixed results. Overall, it seems that surgical skills training outside the operating room is beneficial, but the best method(s) of designing, implementing and evaluating such skills curriculums have yet to be identified.

The laparoscopic totally extraperitoneal (TEP) inguinal hernia repair is an example of a procedure that is associated with a steep learning curve and requires mastery of basic laparoscopic skills. In addition, an increased recurrence and complication rates in the early learning curve of this procedure, underscores the importance of adequate training. The current practice of teaching the TEP repair in the operating room under an apprenticeship-based model is associated with increased operative time and costs. We propose that the training of surgical trainees outside the operating room with a structured, mastery oriented simulation-based curriculum will help reduce the learning curve of the TEP repair, improve operative performance, and decrease operative time and costs.

Conditions

  • Inguinal Hernia

Interventions

BEHAVIORAL

Mastery Learning TEP Curriculum

A simulation-based educational curriculum

PROCEDURE

Current Practice

The current practice of learning how to perform the TEP repair in the operating room is under direct supervision of the staff surgeon without any simulation pre-training.

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • David R Farley, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-01-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01085500 on ClinicalTrials.gov