Brief Title
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
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.
Study Type
Interventional
Primary Outcome
Time to extract the gall bladder.
Secondary Outcome
Serious intra-operative complications
Condition
Cholelithiasis
Intervention
Laparsocopic cholecystectomy
Study Arms / Comparison Groups
Free training
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
64
Start Date
April 2004
Completion Date
December 2014
Primary Completion Date
December 2014
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Martin W von Websky, MD, , [email protected]
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT01615549
Organization ID
Simbionix 20120507
Secondary IDs
SNSF 32003B-120722
Responsible Party
Sponsor
Study Sponsor
University of Zurich
Collaborators
University Hospital, Bonn
Study Sponsor
Martin W von Websky, MD, Principal Investigator, University Hospital Zurich, Department of Surgery
Verification Date
August 2013