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Completed

NCT Number: NCT00555243

Laparoscopic Simulator Training and Its Impact on Surgical Education

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham Department of Ob/Gyn, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Laparoscopic Simulation training

Procedure

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

Other names: Fundamentals of Laparoscopic Surgery

Traditional Surgical Education

Procedure

Traditional surgical teaching (no simulator)

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Nov 8, 2007
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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