Clinical Trials Directory

Trials / Completed

CompletedNCT00555243

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
Phase
N/A
Study type
Interventional
Enrollment
108 (actual)
Sponsor
University of Texas Southwestern Medical Center · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELaparoscopic Simulation trainingfive 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab
PROCEDURETraditional Surgical EducationTraditional surgical teaching (no simulator)

Timeline

Start date
2005-08-01
Primary completion
2011-01-01
Completion
2011-01-01
First posted
2007-11-08
Last updated
2013-01-21

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00555243. Inclusion in this directory is not an endorsement.