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

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Unknown

Conditions

Cholecystitis
Cholecystolithiasis
Cholelithiasis

Treatments

Procedure: Laparsocopic cholecystectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01615549
SNSF 32003B-120722 (Other Grant/Funding Number)
Simbionix 20120507

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

64 participants in 2 patient groups

Free training
Active Comparator group
Treatment:
Procedure: Laparsocopic cholecystectomy
Proficiency-based training
Experimental group
Treatment:
Procedure: Laparsocopic cholecystectomy

Trial contacts and locations

2

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Central trial contact

Martin W von Websky, MD; Dimitri A Raptis, MD, MSc

Data sourced from clinicaltrials.gov

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