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Transfer of Skills From VR-Trainer to Operation Room

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00311792
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : August 30, 2007
Sponsor:
Information provided by:
Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE April 5, 2006
First Posted Date  ICMJE April 6, 2006
Last Update Posted Date August 30, 2007
Study Start Date  ICMJE August 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2007)
Rating Scale Score [ Time Frame: 1 day ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2006)
  • Time to complete operation
  • Error parameters
  • Safety parameters
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2007)
Time used to perform operation [ Time Frame: 1 day ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transfer of Skills From VR-Trainer to Operation Room
Official Title  ICMJE Transfer of Skills From LapSimGyn VR-Simulator to a Laparoscopic Salpingectomy
Brief Summary The purpose is to determine if skills obtained by training in the laparoscopic virtual reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as improved score in a technical skills assessment.
Detailed Description

The purpose is to determine if skills obtained by training in the laparoscopic virtual reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as improved score in a technical skills assessment. Design: prospective randomized double blinded intervention study.

Subjects:Younger gynaecologists (Postgraduate year 2-8) Half are having conventional training the other half is undergoing virtual reality simulator training before performing their first laparoscopic salpingectomy.

Outcome is measured by blinded video evaluation with criteria. The criteria is defined in the previous validated scoring system Objective Structured Assessment of Technical Skills (OSATS)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Condition  ICMJE Clinical Competence
Intervention  ICMJE
  • Behavioral: LapSimGyn training until expert proficiency level is reached
    Two consecutive simulations reaching predefined expert level
  • Behavioral: Traditional clinical education
Study Arms  ICMJE
  • Experimental: 1
    Simulator training
    Intervention: Behavioral: LapSimGyn training until expert proficiency level is reached
  • Active Comparator: 2
    Traditional Clinical education at operating room
    Intervention: Behavioral: Traditional clinical education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2006)
24
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Gyn/obs trainee 1.-2. year, with no experience from advanced laparoscopy

Exclusion Criteria:

  • Advanced laparoscopic experience
  • Previous training in simulator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00311792
Other Study ID Numbers  ICMJE KF 01283756
959587647
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bent Ottesen, MD Dr.Sci Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP