Transfer of Skills From VR-Trainer to Operation Room

August 29, 2007 updated by: Rigshospitalet, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Advanced laparoscopic experience
  • Previous training in simulator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rating Scale Score
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Time used to perform operation
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Director: Bent Ottesen, MD Dr.Sci, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

April 5, 2006

First Submitted That Met QC Criteria

April 5, 2006

First Posted (Estimate)

April 6, 2006

Study Record Updates

Last Update Posted (Estimate)

August 30, 2007

Last Update Submitted That Met QC Criteria

August 29, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KF 01283756
  • 959587647

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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