Clinical trial NCT01615549: Efficacy of Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy on a Virtual Reality Simulator
Official title: Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy Using the Simbionix LAP Mentor™. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholelithiasis
Cholecystitis
Cholecystolithiasis
Keywords: Cholecystectomy
Virtual reality device
Training
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University Hospital, Bonn
name: University Hospital, Basel, Switzerland
name: University of Lausanne Hospitals
First posted: 2012-06-08
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to extract the gall bladder.
timeFrame: 10 minutes in average
Secondary outcomes:
measure: Serious intra-operative complications
timeFrame: 10 minutes in average
measure: Safe cautery
timeFrame: 10 minutes in average
measure: Total path length of right instrument
timeFrame: 10 minutes in average
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Surgery
Study officials:
affiliation: University Hospital Zurich, Department of Surgery
name: Martin W von Websky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Zurich, Department of Surgery
name: Dimitri A Raptis, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Zürich
name: Pierre-Alain Clavien, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital Zurich, Department of Surgery
name: Dieter Hahnloser, MD
role: STUDY_DIRECTOR
References:
citation: 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.