Transfer of Skills From VR-Trainer to Operation Room

Clinical Competence Clinical Trial

Official title:

Transfer of Skills From LapSimGyn VR-Simulator to a Laparoscopic Salpingectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311792
• Other study ID #: KF 01283756
• Secondary ID: 959587647
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 5, 2006
• Last updated: August 29, 2007
• Start date: August 2006
• Est. completion date: August 2007

Study information

• Verified date: August 2007
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Advanced laparoscopic experience

• Previous training in simulator

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor)

Related Conditions & MeSH terms

• Clinical Competence

Intervention

Behavioral:
• LapSimGyn training until expert proficiency level is reached
Two consecutive simulations reaching predefined expert level
• Traditional clinical education

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating Scale Score		1 day
Secondary	Time used to perform operation		1 day