Transfer of Skills From VR-Trainer to Operation Room

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00311792
First received: April 5, 2006
Last updated: August 29, 2007
Last verified: August 2007
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
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
Experimental: 1
Simulator training
Behavioral: LapSimGyn training until expert proficiency level is reached
Two consecutive simulations reaching predefined expert level
Active Comparator: 2
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
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: NCT00311792

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Director: Bent Ottesen, MD Dr.Sci Rigshospitalet, Denmark
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00311792     History of Changes
Other Study ID Numbers: KF 01283756, 959587647
Study First Received: April 5, 2006
Last Updated: August 29, 2007
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 October 16, 2014