Laparoscopic Simulator Training and Its Impact on Surgical Education

Surgical Procedure, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555243
• Other study ID #: UTSW IRB 042006-034
• Status: Completed
• Phase: N/A
• First received: November 6, 2007
• Last updated: January 18, 2013
• Start date: August 2005
• Est. completion date: January 2011

Study information

• Verified date: November 2007
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified
• Surgical Simulation

Intervention

Procedure:
• Laparoscopic Simulation training
five 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab
• Traditional Surgical Education
Traditional surgical teaching (no simulator)

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Department of Ob/Gyn	Birmingham	Alabama
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Texas at Houston Department of Ob/Gyn	Houston	Texas
United States	Uniformed Services University of the Health Sciences	Washington	District of Columbia

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents		Over the course of one resident rotation (4-6 weeks)	Yes
Secondary	Determine if the level of improvement is inversely related to resident level of training.		Over the course of one resident rotation (4-6 weeks)	No
Secondary	Calculate receiver operator curves to aid in the establishment of a "passing score" threshold on the validated laparoscopic simulators		Over the course of one resident rotation (4-6 weeks)	No
Secondary	Establish whether psychomotor testing predicts surgical proficiency and helps identify those who may need more intensive training over the course of their education.		Over the course of one resident rotation (4-6 weeks)	Yes