Comparison of Dry-lab Laparoscopic Training and Robotic Virtual Simulator

Study Overview
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Brief Summary
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The objective of the present study is to compare the effectiveness of dry-lab laparoscopic training and robotic simulator training among medical students without any prior laparoscopic experience.

Detailed Description
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This study will be a randomized clinical trial conducted at the Swiss Foundation For Innovation And Training In Surgery (SFITS), which is part of the Geneva University Hospital in Switzerland. Recruitment of a sample of 100 medical students with no prior experience in laparoscopic surgery will be performed. The participants will be randomized in 2 groups (50 participants in each group). The study group will undergo a single session of training using a standard, dry-lab laparoscopic box. The control group will undergo a single session of training using the da Vinci Skills Simulator. Post-training surgical skills for both groups will be measured using exercises from the FLS manual skills assessment. The overall performance on the FLS test will be compared between the two groups .

Official Title
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Comparison of Dry-lab Laparoscopic Training and Robotic Virtual Simulator Training to Develop Basic Laparoscopic Skills: A Randomized Clinical Trial

Conditions
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Surgery

Intervention / Treatment
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* Device: da Vinci Simulator
* Device: Laparascopic training box


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical student at the University of Geneva Exclusion Criteria: Previous laparoscopic experience Stereoblindness

Ages Eligible for Study
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Minimum Age: 18 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

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Da Vinci Simulator<br>Participants will undergo a single session of training using the da Vinci Simulator | Device: da Vinci Simulator<br>* Single training session<br>|
| Active Comparator: Laparascopic training box<br>Participants will undergo a single session of training using a laparoscopic training box | Device: Laparascopic training box<br>* Single training session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLS score post-training session | This score is a composite outcome combining the time needed to finish the exercises and the proficiency in performing them (number of dropped objects, lack of movements precision, exercises rules violations, etc.). The score will go from 0 (worst score) to 800 (best score), with a passing score of 356. | Up to 1 hour after the beginning of the exam session. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Times needed to perform training exercises | Time required to perform the training exercises will be measured in both groups (dry-lab laparoscopic box and da Vinci skills simulator) | Up to 1 hour after the beginning of the training session |