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| ID | Type | Description | Link |
|---|---|---|---|
| SNSF 32003B-120722 | Other Grant/Funding Number | Swiss National Science Foundation (SNSF) |
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| Name | Class |
|---|---|
| University Hospital, Bonn | OTHER |
| University Hospital, Basel, Switzerland | OTHER |
| University of Lausanne Hospitals | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free training | Active Comparator |
| |
| Proficiency-based training | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparsocopic cholecystectomy | Procedure | Perform laparsocopic cholecystectomy on a virtual reality devise |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin W von Websky, MD | Contact | martin@websky.de | ||
| Dimitri A Raptis, MD, MSc | Contact | +41798820542 | dimitri.raptis@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Martin W von Websky, MD | University Hospital Zurich, Department of Surgery | Principal Investigator |
| Dimitri A Raptis, MD, MSc | University Hospital Zurich, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23942532 | Derived | von Websky MW, Raptis DA, Vitz M, Rosenthal R, Clavien PA, Hahnloser D. Access to a simulator is not enough: the benefits of virtual reality training based on peer-group-derived benchmarks--a randomized controlled trial. World J Surg. 2013 Nov;37(11):2534-41. doi: 10.1007/s00268-013-2175-6. |
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D002764 | Cholecystitis |
| D041761 | Cholecystolithiasis |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
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| 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 |
| Pierre-Alain Clavien, MD, PhD | University Hospital, Zürich | Study Chair |
| Dieter Hahnloser, MD | University Hospital Zurich, Department of Surgery | Study Director |
| University Hospital Zurich, Department of Surgery | Active, not recruiting | Zurich | CH-8091 | Switzerland |