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Laparoscopic Simulator Training and Its Impact on Surgical Education

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00555243
Enrollment
108
Registered
2007-11-08
Start date
2005-08-31
Completion date
2011-01-31
Last updated
2013-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Procedure, Unspecified, Surgical Simulation

Keywords

Laparoscopic Surgical Simulation

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.

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.

Interventions

five 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab

PROCEDURETraditional Surgical Education

Traditional surgical teaching (no simulator)

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frame
Whether laparoscopic simulators truly affect real time performance in the operating room among Gynecology residentsOver the course of one resident rotation (4-6 weeks)

Secondary

MeasureTime frame
Determine if the level of improvement is inversely related to resident level of training.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 simulatorsOver 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.Over the course of one resident rotation (4-6 weeks)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026