Laparoscopic Simulator Training and Its Impact on Surgical Education

Study Overview
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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.

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

Conditions
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Surgical Procedure, Unspecified, Surgical Simulation

Intervention / Treatment
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* Procedure: Laparoscopic Simulation training
* Procedure: Traditional Surgical Education


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Laparoscopic Simulation Education | Procedure: Laparoscopic Simulation training<br>* five 30-minute faculty-directed sessions at the Laparoscopic Simulator Lab<br>* Other names: Fundamentals of Laparoscopic Surgery;|
| Placebo Comparator: 2<br> | Procedure: Traditional Surgical Education<br>* Traditional surgical teaching (no simulator)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time 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 simulators |  | Over 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Surgical Simulation