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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Zurich
Sponsor:
Collaborators:
University Hospital, Bonn
University Hospital, Basel, Switzerland
University of Lausanne Hospitals
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01615549
First received: May 23, 2012
Last updated: August 22, 2013
Last verified: August 2013

May 23, 2012
August 22, 2013
April 2004
December 2014   (final data collection date for primary outcome measure)
Time to extract the gall bladder. [ Time Frame: 10 minutes in average ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01615549 on ClinicalTrials.gov Archive Site
  • Serious intra-operative complications [ Time Frame: 10 minutes in average ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 10 minutes in average ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 10 minutes in average ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Efficacy of Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy on a Virtual Reality Simulator
Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy Using the Simbionix LAP Mentor™. A Randomized Controlled Trial

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Cholelithiasis
  • Cholecystitis
  • Cholecystolithiasis
Procedure: Laparsocopic cholecystectomy
Perform laparsocopic cholecystectomy on a virtual reality devise
Other Name: Key whole gall bladder surgery
  • Active Comparator: Free training
    Intervention: Procedure: Laparsocopic cholecystectomy
  • Experimental: Proficiency-based training
    Intervention: Procedure: Laparsocopic cholecystectomy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact: Martin W von Websky, MD martin@websky.de
Contact: Dimitri A Raptis, MD, MSc +41798820542 dimitri.raptis@usz.ch
Switzerland
 
NCT01615549
Simbionix 20120507, SNSF 32003B-120722
Yes
University of Zurich
University of Zurich
  • University Hospital, Bonn
  • University Hospital, Basel, Switzerland
  • University of Lausanne Hospitals
Principal Investigator: Martin W von Websky, MD University Hospital Zurich, Department of Surgery
Principal Investigator: Dimitri A Raptis, MD, MSc University Hospital Zurich, Department of Surgery
Study Chair: Pierre-Alain Clavien, MD, PhD University Hospital, Zürich
Study Director: Dieter Hahnloser, MD University Hospital Zurich, Department of Surgery
University of Zurich
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP