A Pilot Study on Training Simulator Efficacy

Study Overview
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Brief Summary
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The purpose of this study is to plan an effective learning path in minimally invasive thoracic and general surgery with a virtual training simulator for trainees and to assess the improvement of residents' surgical skills by the introduction of this virtual training program.

Detailed Description
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All thoracic and general surgery trainees at the first and second year of residency will be randomized in two groups: A) trainees undergoing an intensive (twice a week) virtual training program and B) those undergoing a non-intensive virtual training program (once a week). The virtual training program will be organized in 4 modules, each of 12 weeks and, according to the training simulator instructions, for each surgical skill there are predetermined goals to be achieved by the trainee. Data about duration of surgical maneuvers and type and number of mistakes made by the trainee at each training session will be collected and compared with those of the same trainee at the previous session; this will assess the number of training sessions required to achieve the training simulator predetermined goals. Moreover, the same data will be registered at the beginning and at the end of each courses to compare the two groups of trainees (intensive vs non-intensive program).

Official Title
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Training Simulator Efficacy in Developing Thoracic and General Surgical Skills in an Academic Residency Program: a Pilot Study

Conditions
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Laparoscopic Surgery, Medical Education, Simulation Training

Intervention / Treatment
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* Other: LapSim training
* Other: LapSim exam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trainees at the first and second year of residency in thoracic or general surgery Exclusion Criteria: Fully trained surgeons Persons who are not trainees at year of specialization higher than the second

Ages Eligible for Study
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Minimum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive training group<br>Participants in this group will undergo an intensive virtual training program twice a week | Other: LapSim training<br>* Complete 4 courses, each of 12 weeks, of virtual reality simulation on LapSim surgical simulator.<br>Other: LapSim exam<br>* Completed at the beginning and at the end of each of the 4 courses the corresponding exam task.<br>|
| Active Comparator: Non-Intensive training group<br>Participants in this group will undergo a non-intensive virtual training program once a week | Other: LapSim training<br>* Complete 4 courses, each of 12 weeks, of virtual reality simulation on LapSim surgical simulator.<br>Other: LapSim exam<br>* Completed at the beginning and at the end of each of the 4 courses the corresponding exam task.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Learning curves of time, errors and economy of motion for each training tasks | For each task, the computer automatically measures set parameters. Time, errors and economy of motion will be used in data analysis to create the learning curves for both intensive and non-intensive training group. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive vs non-intensive training group | For each exam tasks of the four training courses, compare the difference between the intensive and non-intensive training group, before and after each program training. Time, errors and economy of motion will be used in data analysis. | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Education, Simulation, Virtual reality, Laparoscopic surgery, Learning curve, Endoscopic surgery, Thoracoscopic surgery