Cholecystitis, Cholecystolithiasis, Cholelithiasis
Conditions
Keywords
Cholecystectomy, Virtual reality device, Training
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.
Interventions
PROCEDURELaparsocopic cholecystectomy
Perform laparsocopic cholecystectomy on a virtual reality devise
Sponsors
University Hospital, Bonn
University Hospital, Basel, Switzerland
University of Lausanne Hospitals
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Serious intra-operative complications | 10 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. |
| Safe cautery | 10 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. |
| Total path length of right instrument | 10 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. |
Countries
Switzerland
Contacts
Primary ContactMartin W von Websky, MD
Backup ContactDimitri A Raptis, MD, MSc
Outcome results
None listed