Laparoscopic Simulator Training and Its Impact on Surgical Education

NCT ID: NCT00555243

Last Updated: 2013-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2011-01-31

Brief Summary

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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

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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.

Conditions

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Surgical Procedure, Unspecified Surgical Simulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Laparoscopic Simulation Education

Group Type EXPERIMENTAL

Laparoscopic Simulation training

Intervention Type PROCEDURE

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

2

Group Type PLACEBO_COMPARATOR

Traditional Surgical Education

Intervention Type PROCEDURE

Traditional surgical teaching (no simulator)

Interventions

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Laparoscopic Simulation training

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

Intervention Type PROCEDURE

Traditional Surgical Education

Traditional surgical teaching (no simulator)

Intervention Type PROCEDURE

Other Intervention Names

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Fundamentals of Laparoscopic Surgery

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ochsner Health System

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role collaborator

Orlando Health, Inc.

OTHER

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rajiv B Gala, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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University of Alabama at Birmingham Department of Ob/Gyn

Birmingham, Alabama, United States

Site Status

Uniformed Services University of the Health Sciences

Washington D.C., District of Columbia, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

University of Texas at Houston Department of Ob/Gyn

Houston, Texas, United States

Site Status

Countries

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United States

References

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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):578-584. doi: 10.1097/AOG.0b013e318283578b.

Reference Type DERIVED
PMID: 23635621 (View on PubMed)

Other Identifiers

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UTSW IRB 042006-034

Identifier Type: -

Identifier Source: org_study_id

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