Laparoscopic Simulator Training and Its Impact on Surgical Education

January 18, 2013 updated by: University of Texas Southwestern Medical Center

An Evaluation of Validated Laparoscopic Skills Simulators and the Impact on Operating Room Performance

The primary goal of this study is to answer whether validated laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We have designed a randomized control trial to assess the impact of a laparoscopic simulator curriculum on operating room performance amongst gynecology residents. At the beginning of the study, each resident that chooses to participate will take a multiple choice pre-test assessing his or her background knowledge of laparoscopic surgical principles. Everyone will then listen to a series of lectures / video demonstrations teaching the fundamentals of laparoscopic surgery. The final part of the orientation is to have each resident perform 5 tasks on the laparoscopic simulators (peg transfer, endoloop, pattern cutting, intracorporeal suturing, and extracorporeal suturing) while being proctored by a faculty member who is timing the task and recording any errors made. Each resident will have 2 proctored performances (pre- and post) on the simulator and it will be set up as a typical OSCE-type exam. We chose to have them perform 2 repetitions as opposed to the usual 1 (like on the MCAT, SAT, or other high stake exam) to allow for potential unfamiliarity with the simulator equipment.

The residents will then perform a laparoscopic tubal ligation with a faculty member when they begin their Benign Gynecology rotation. Each resident will subsequently be randomized either traditional teaching (no simulator) or five 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab. Those randomized to simulation training can practice and perform as many repetitions necessary on the simulator to achieve proficiency. Prior to completing the rotation, the residents will perform another laparoscopic tubal ligation with a faculty member blinded to whether they randomized to simulator training to re-assess their technical skills. The resident will have another proctored examination of simulator performance on the five tasks. Finally, a videotape review by independent observers will verify precision of the surgical evaluations at the conclusion of the study.

Study Type

Interventional

Enrollment (Actual)

108

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
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • University of Alabama at Birmingham Department of Ob/Gyn
    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Uniformed Services University of the Health Sciences
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77026
        • University of Texas at Houston Department of Ob/Gyn

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All Ob/Gyn residents in post-graduate years 1-4 from ACGME accredited programs

Exclusion Criteria:

  • none

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Procedure: Traditional Surgical Education
Traditional surgical teaching (no simulator)
EXPERIMENTAL: 1
Laparoscopic Simulation Education
Procedure: Laparoscopic Simulation training
five 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab
Other Names:
  • Fundamentals of Laparoscopic Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Whether laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents
Time Frame: Over the course of one resident rotation (4-6 weeks)
Over the course of one resident rotation (4-6 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine if the level of improvement is inversely related to resident level of training.
Time Frame: Over the course of one resident rotation (4-6 weeks)
Over the course of one resident rotation (4-6 weeks)
Calculate receiver operator curves to aid in the establishment of a "passing score" threshold on the validated laparoscopic simulators
Time Frame: Over the course of one resident rotation (4-6 weeks)
Over the course of one resident rotation (4-6 weeks)
Establish whether psychomotor testing predicts surgical proficiency and helps identify those who may need more intensive training over the course of their education.
Time Frame: Over the course of one resident rotation (4-6 weeks)
Over the course of one resident rotation (4-6 weeks)

Collaborators and Investigators

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

Sponsor

University of Texas Southwestern Medical Center

Collaborators

The University of Texas Health Science Center, Houston
University of Alabama at Birmingham
Virginia Commonwealth University
Uniformed Services University of the Health Sciences
Orlando Health, Inc.
Ochsner Health System

Investigators

  • Principal Investigator: Rajiv B Gala, MD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2005

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

November 6, 2007

First Submitted That Met QC Criteria

November 6, 2007

First Posted (ESTIMATE)

November 8, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2013

Last Update Submitted That Met QC Criteria

January 18, 2013

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UTSW IRB 042006-034

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.

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