Laparoscopic Simulator Training and Its Impact on Surgical Education

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00555243
First received: November 6, 2007
Last updated: January 18, 2013
Last verified: November 2007
  Purpose

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 Intervention
Surgical Procedure, Unspecified
Surgical Simulation
Procedure: Laparoscopic Simulation training
Procedure: Traditional Surgical Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: An Evaluation of Validated Laparoscopic Skills Simulators and the Impact on Operating Room Performance

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 108
Study Start Date: August 2005
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555243

Locations
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
Principal Investigator: Rajiv B Gala, MD University of Texas Southwestern Medical Center
  More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00555243     History of Changes
Other Study ID Numbers: UTSW IRB 042006-034
Study First Received: November 6, 2007
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Laparoscopic Surgical Simulation

ClinicalTrials.gov processed this record on April 23, 2014