Transfer of Skills From VR-Trainer to Operation Room - Full Text View

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00311792

Purpose

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.

Condition	Intervention	Phase
Clinical Competence	Behavioral: LapSimGyn training until expert proficiency level is reached Behavioral: Traditional clinical education	Phase II Phase III

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Transfer of Skills From LapSimGyn VR-Simulator to a Laparoscopic Salpingectomy

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Rating Scale Score [ Time Frame: 1 day ]

Secondary Outcome Measures:

Time used to perform operation [ Time Frame: 1 day ]

Enrollment:	24
Study Start Date:	August 2006
Study Completion Date:	August 2007

Arms	Assigned Interventions
1: Experimental Simulator training	Behavioral: LapSimGyn training until expert proficiency level is reached Two consecutive simulations reaching predefined expert level
2: Active Comparator Traditional Clinical education at operating room	Behavioral: Traditional clinical education

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)

Eligibility

Ages Eligible for Study:	25 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Advanced laparoscopic experience
Previous training in simulator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311792

Locations

Denmark
Rigshospitalet
Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Study Director:

Bent Ottesen, MD Dr.Sci

Rigshospitalet, Denmark

More Information

Additional Information:

Project description in Danish This link exits the ClinicalTrials.gov site

Publications:

Issenberg SB, McGaghie WC, Petrusa ER, Lee Gordon D, Scalese RJ. Features and uses of high-fidelity medical simulations that lead to effective learning: a BEME systematic review. Med Teach. 2005 Jan;27(1):10-28. Review.

Study ID Numbers:	KF 01283756, 959587647
Study First Received:	April 5, 2006
Last Updated:	August 29, 2007
ClinicalTrials.gov Identifier:	NCT00311792 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:

training
teaching
curriculum

ClinicalTrials.gov processed this record on May 07, 2009