Trial record 4 of 46 for:    Open Studies | "Cholelithiasis"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Zurich
Sponsor:
Collaborators:
University Hospital, Bonn
University Hospital, Basel, Switzerland
University of Lausanne Hospitals
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01615549
First received: May 23, 2012
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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 Intervention
Cholelithiasis
Cholecystitis
Cholecystolithiasis
Procedure: Laparsocopic cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy Using the Simbionix LAP Mentor™. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Time to extract the gall bladder. [ Time Frame: 10 minutes in average ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 minutes in average ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 10 minutes in average ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 10 minutes in average ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 64
Study Start Date: April 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Department of Surgery Active, not recruiting
Zurich, Switzerland, CH-8091
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         
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
  More Information

Additional Information:
No publications provided by University of Zurich

Additional 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
Study First Received: May 23, 2012
Last Updated: August 22, 2013
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on July 22, 2014