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

Sponsor

University of Zurich (Other)

Overall Status

Unknown status

CT.gov ID

NCT01615549

Collaborator

University Hospital, Bonn (Other), University Hospital, Basel, Switzerland (Other), University of Lausanne Hospitals (Other)

Enrollment

Locations

Arms

128

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2004

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Time to extract the gall bladder. [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

Serious intra-operative complications [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.
Safe cautery [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.
Total path length of right instrument [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich	Zurich		Switzerland	8091
2	University Hospital Zurich, Department of Surgery	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