Efficacy of Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy on a Virtual Reality Simulator

Study Overview
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Brief Summary
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Virtual reality devices are widely accepted tools to familiarize surgical novices with the principles of laparoscopy. Free Virtual reality training will be tested against basic training and efficacy assessed in a randomized controlled trial of surgical novices.

Detailed Description
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Virtual reality simulators are widely accepted tools to familiarize surgical novices with the principles of laparoscopy without jeopardizing patient safety. However, access to a Virtual reality simulator and initial instruction alone followed by free training of the surgical novice may not be sufficient to achieve the training goals efficiently. The aims of this study are to determine if proficiency based laparoscopic training on the Simbionx LAP Mentor™ with external formative assessment using peer group derived benchmarks is superior to free training with self-assessment using the simulated laparoscopic cholecystectomy procedure with different endpoints (time to extract the gallbladder, serious complications, safe cautery and instrument pathways) as outcome parameters.

Official Title
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Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy Using the Simbionix LAP Mentor™. A Randomized Controlled Trial

Conditions
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Cholelithiasis, Cholecystitis, Cholecystolithiasis

Intervention / Treatment
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* Procedure: Laparsocopic cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgical novices (trainees / residents) Performed less than five laparoscopic procedures No previous simulator experience Exclusion Criteria: Specialist surgeons Performed more than five laparoscopic procedures Previous experience with a simulator
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 |
| --- | --- |
| Active Comparator: Free training<br> | Procedure: Laparsocopic cholecystectomy<br>* Perform laparsocopic cholecystectomy on a virtual reality devise<br>* Other names: Key whole gall bladder surgery;|
| Experimental: Proficiency-based training<br> | Procedure: Laparsocopic cholecystectomy<br>* Perform laparsocopic cholecystectomy on a virtual reality devise<br>* Other names: Key whole gall bladder surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to extract the gall bladder. | The time to extract the gall bladder on a virtual simulator is typically 10 minutes. However this varies according to the settings of the difficulty chosen on the virtual reality software. This is a continuous variable measuring the duration for a trainee surgeon to extract the gall bladder (measured in seconds). The start point is the beginning of the exercise and the finishing point is once the gall bladder is completely resected (gall bladder mobilized and the cystic duct and artery dissected and ligated). | 10 minutes in average | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious intra-operative complications | Serious complications on a virtual simulator are considered injuries to the bile duct, hepatic artery, the bowel, or the liver bed. Such complications are automatically detected by the virtual reality software and recorded in a special database. This is a continuous variable with 0 indicating no complications, 1 indicating one complication, 2 indicating two complications, etc. | 10 minutes in average | 
| Safe cautery | During a virtual laparoscopic cholecycetoctomy, cautery (also know as a coagulator, a device that utilizes electrical current for dissection or bleeding control)is commonly used to mobilize the gall bladder away from the liver bed. The virtual simulator software measures the percentage of the unsafe use of cautery. This is a continuous variable with 100% safe cautery indicating no unsafe cauterization around important structures such as the bowel, bile duct, hepatic artery, etc. | 10 minutes in average | 
| Total path length of right instrument | The total path length of the right instrument used to extract the gall bladder during a virtual laparoscopic cholecystectomy task measures the in and out movement of the right instrument. The higher the value, the more unnecessary movements are made during the task. | 10 minutes in average | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholecystectomy, Virtual reality device, Training