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

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ClinicalTrials.gov Identifier: NCT01615549
Recruitment Status : Unknown
Verified August 2013 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : June 8, 2012
Last Update Posted : August 23, 2013
Sponsor:
Collaborators:
University Hospital, Bonn
University Hospital, Basel, Switzerland
University of Lausanne Hospitals
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Cholelithiasis Cholecystitis Cholecystolithiasis Procedure: Laparsocopic cholecystectomy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy Using the Simbionix LAP Mentor™. A Randomized Controlled Trial
Study Start Date : April 2004
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Free training Procedure: Laparsocopic cholecystectomy
Perform laparsocopic cholecystectomy on a virtual reality devise
Other Name: Key whole gall bladder surgery

Experimental: Proficiency-based training Procedure: Laparsocopic cholecystectomy
Perform laparsocopic cholecystectomy on a virtual reality devise
Other Name: Key whole gall bladder surgery




Primary Outcome Measures :
  1. Time to extract the gall bladder. [ Time Frame: 10 minutes in average ]
    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).


Secondary Outcome Measures :
  1. Serious intra-operative complications [ Time Frame: 10 minutes in average ]
    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.

  2. Safe cautery [ Time Frame: 10 minutes in average ]
    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.

  3. Total path length of right instrument [ Time Frame: 10 minutes in average ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615549


Contacts
Contact: Martin W von Websky, MD martin@websky.de
Contact: Dimitri A Raptis, MD, MSc +41798820542 dimitri.raptis@usz.ch

Locations
Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Oliver M Fisher, MD         
Contact: Dimitri A Raptis, MD, MSc    +41798820542    dimitri.raptis@usz.ch   
Principal Investigator: Oliver M Fisher, MD         
Sub-Investigator: Dimitri A Raptis, MD, MSc         
University Hospital Zurich, Department of Surgery Active, not recruiting
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
University of Zurich
University Hospital, Bonn
University Hospital, Basel, Switzerland
University of Lausanne Hospitals
Investigators
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01615549     History of Changes
Other Study ID Numbers: Simbionix 20120507
SNSF 32003B-120722 ( Other Grant/Funding Number: Swiss National Science Foundation (SNSF) )
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: August 23, 2013
Last Verified: August 2013

Keywords provided by University of Zurich:
Cholecystectomy
Virtual reality device
Training

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Cholelithiasis
Cholecystolithiasis
Gallstones
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical