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

November 6, 2007
January 18, 2013
August 2005
January 2011   (final data collection date for primary outcome measure)
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 ]
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) ]
Complete list of historical versions of study NCT00555243 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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) ]
  • 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) ]
  • 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) ]
Not Provided
Not Provided
 
Laparoscopic Simulator Training and Its Impact on Surgical Education
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • Surgical Procedure, Unspecified
  • Surgical Simulation
  • Procedure: Laparoscopic Simulation training
    five 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab
    Other Name: Fundamentals of Laparoscopic Surgery
  • Procedure: Traditional Surgical Education
    Traditional surgical teaching (no simulator)
  • Experimental: 1
    Laparoscopic Simulation Education
    Intervention: Procedure: Laparoscopic Simulation training
  • Placebo Comparator: 2
    Intervention: Procedure: Traditional Surgical Education
Gala R, Orejuela F, Gerten K, Lockrow E, Kilpatrick C, Chohan L, Green C, Vaught J, Goldberg A, Schaffer J. Effect of validated skills simulation on operating room performance in obstetrics and gynecology residents: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):578-84. doi: 10.1097/AOG.0b013e318283578b.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00555243
UTSW IRB 042006-034
No
University of Texas Southwestern Medical Center
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
Principal Investigator: Rajiv B Gala, MD University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP