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

Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01615549
• Other study ID #: Simbionix 20120507
• Secondary ID: SNSF 32003B-1207
• Status: Recruiting
• Phase: N/A
• First received: May 23, 2012
• Last updated: August 22, 2013
• Start date: April 2004
• Est. completion date: December 2014

Study information

• Verified date: August 2013
• Source: University of Zurich
• Contact: Martin W von Websky, MD
• Email: martin[@]websky.de
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Laparsocopic cholecystectomy
Perform laparsocopic cholecystectomy on a virtual reality devise

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich
Switzerland	University Hospital Zurich, Department of Surgery	Zurich

Sponsors (4)

Lead Sponsor	Collaborator
University of Zurich	University Hospital, Basel, Switzerland, University Hospital, Bonn, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No

External Links

•   The Simbionx LAP Mentor™