Trial on Laparoscopic Simulation Based on Mentoring

Study Overview
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Brief Summary
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More than 50 residents in surgical specialities (OB&G, General surgery and Urology) from a single university in Italy will be randomized into two groups, after a stratification based on residency year and laparoscopic/simulator experience. The first one will train to FLS (fundamentals of laparoscopic surgery) following pre-recorded instruction from course materials; the second one will be mentored by a proctor in single training section. The aim is to evaluate the best way to train residents applying for the very first time in an extensive way the fundamentals of laparoscopic surgery program in an Italian Institution.

Detailed Description
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A complete 5-skills based FLS (fundamentals of laparoscopic surgery) curriculum is proposed to each resident enrolled in the trial. The first group trains with videos and written instructions, without any kind of support from a tutor. The second group is aided by a tutor, receiving tailored teaching and mentoring. The primary goal was to asses the impact of tutoring in Passing the FLS examination at the end of a 3-months training: the outcome is the dichotomous PASS/DON'T PASS THE EXAM. At the same time the investigators assess the performance to record and evaluate any differences in groups and subgroups (year of residency, gender, specialty, etc.). The evaluation was based on FLS program standards, recording time and penalties. The training and evaluation setting was created to exactly reproduce the FLS one, mostly using the FLS material itself, or using FLS admitted/compatible instrumentation.

Official Title
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Comparison of Laparoscopic Simulation Training Between Mentoring and Self-learning Technique

Conditions
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Performance of Wrong Procedure (Operation)

Intervention / Treatment
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* Other: Self-learning
* Other: Mentoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Residents in surgical specialities at University of Brescia Exclusion Criteria: Residents not available for the training (outside the Country, not interested, etc.)

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 70 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: self-learning<br>Residents training alone with pre-recorded instructions. No tutor intervention, only self-learning training Intervention Type: Behavioral (video-based and instruction based learning) | Other: Self-learning<br>* Every resident will train following the video instruction included in the FLS course material and related written instruction only<br>|
| Other: Mentoring<br>Residents training with a mentor, giving tailored instruction to each of them and correction to wrong behaviours. Intervention Type: Behavioral (tutored learning) | Other: Mentoring<br>* A tutor will follow each resident during learning, giving instruction, examples and any kind of suggestions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance at FLS (fundamentals of laparoscopic surgery) test at the end of training as defined from SAGES | 2 months for the training and final evaluation in 2 weeks. Parameters evaluated during the final test are as defined by SAGES at http://www.flsprogram.org in the manual skills module. | 2 months to compleete the training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proctor, Residents, Training, simulation, mentoring