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Laparoscopic Simulator Training and Its Impact on Surgical Education

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ClinicalTrials.gov Identifier: NCT00555243
Recruitment Status : Completed
First Posted : November 8, 2007
Last Update Posted : January 21, 2013
Sponsor:
Collaborators:
Ochsner Health System
University of Alabama at Birmingham
The University of Texas Health Science Center, Houston
Uniformed Services University of the Health Sciences
Orlando Health, Inc.
Virginia Commonwealth University
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Surgical Procedure, Unspecified Surgical Simulation Procedure: Laparoscopic Simulation training Procedure: Traditional Surgical Education Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: An Evaluation of Validated Laparoscopic Skills Simulators and the Impact on Operating Room Performance
Study Start Date : August 2005
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Laparoscopic Simulation Education
 Procedure: Laparoscopic Simulation training
five 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab
Other Name: Fundamentals of Laparoscopic Surgery
Placebo Comparator: 2 Procedure: Traditional Surgical Education
Traditional surgical teaching (no simulator)


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555243


Locations
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United States, Alabama
University of Alabama at Birmingham Department of Ob/Gyn
Birmingham, Alabama, United States, 35243
United States, District of Columbia
Uniformed Services University of the Health Sciences
Washington, District of Columbia, United States, 20307
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
University of Texas at Houston Department of Ob/Gyn
Houston, Texas, United States, 77026
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Ochsner Health System
University of Alabama at Birmingham
The University of Texas Health Science Center, Houston
Uniformed Services University of the Health Sciences
Orlando Health, Inc.
Virginia Commonwealth University
Investigators
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Principal Investigator: Rajiv B Gala, MD University of Texas Southwestern Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00555243    
Other Study ID Numbers: UTSW IRB 042006-034
First Posted: November 8, 2007    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: November 2007
Keywords provided by University of Texas Southwestern Medical Center:
Laparoscopic Surgical Simulation