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

Not Applicable
Conditions
Cholecystolithiasis
Cholecystitis
Cholelithiasis
Interventions
Procedure: Laparsocopic cholecystectomy
Registration Number
NCT01615549
Lead Sponsor
University of Zurich
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
64
Inclusion Criteria
  • Surgical novices (trainees / residents)
  • Performed less than five laparoscopic procedures
  • No previous simulator experience
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Exclusion Criteria
  • Specialist surgeons
  • Performed more than five laparoscopic procedures
  • Previous experience with a simulator
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Free trainingLaparsocopic cholecystectomy-
Proficiency-based trainingLaparsocopic cholecystectomy-
Primary Outcome Measures
NameTimeMethod
Time to extract the gall bladder.10 minutes in average

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).

Secondary Outcome Measures
NameTimeMethod
Total path length of right instrument10 minutes in average

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.

Safe cautery10 minutes in average

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.

Serious intra-operative complications10 minutes in average

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.

Trial Locations

Locations (2)

University Hospital Zurich

🇨🇭

Zurich, Switzerland

University Hospital Zurich, Department of Surgery

🇨🇭

Zurich, Switzerland

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