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

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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