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

Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy Using the Simbionix LAP Mentor™. A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Cholecystitis; Cholelithiasis; Cholecystolithiasis
• Intervention / Treatment: Procedure: Laparsocopic cholecystectomy

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
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin W von Websky, MD; Email: martin@websky.de
• Study Contact Backup: Name: Dimitri A Raptis, MD, MSc; Phone Number: +41798820542; Email: dimitri.raptis@usz.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • University Hospital Zürich
    • Contact: Dimitri A Raptis, MD, MSc; Phone Number: +41798820542; Email: dimitri.raptis@usz.ch
    • Contact: Oliver M Fisher, MD
    • Principal Investigator: Oliver M Fisher, MD
    • Sub-Investigator: Dimitri A Raptis, MD, MSc
  • Zurich, Switzerland, CH-8091
    • Active, not recruiting
    • University Hospital Zurich, Department of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Free training	Procedure: Laparsocopic cholecystectomy; Perform laparsocopic cholecystectomy on a virtual reality devise; Other Names: Key whole gall bladder surgery
Experimental: Proficiency-based training	Procedure: Laparsocopic cholecystectomy; Perform laparsocopic cholecystectomy on a virtual reality devise; Other Names: Key whole gall bladder surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to extract the gall bladder.	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).	10 minutes in average

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious intra-operative complications	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.	10 minutes in average
Safe cautery	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.	10 minutes in average
Total path length of right instrument	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.	10 minutes in average

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: University Hospital, Basel, Switzerland; University Hospital, Bonn; 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• The Simbionx LAP Mentor™

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: May 23, 2012
• First Submitted That Met QC Criteria: June 6, 2012
• First Posted (Estimate): June 8, 2012

Study Record Updates

• Last Update Posted (Estimate): August 23, 2013
• Last Update Submitted That Met QC Criteria: August 22, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Training; Cholecystectomy; Virtual reality device
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Cholecystitis; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: Simbionix 20120507; SNSF 32003B-120722 (Other Grant/Funding Number: Swiss National Science Foundation (SNSF))