NCT00311792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

August 30, 2007

Status Verified

August 1, 2007

First QC Date

April 5, 2006

Last Update Submit

August 29, 2007

Conditions

Clinical Competence

Keywords

trainingteachingcurriculum

Outcome Measures

Primary Outcomes (1)

  • Rating Scale Score

    1 day

Secondary Outcomes (1)

  • Time used to perform operation

    1 day

Study Arms (2)

1

EXPERIMENTAL

Simulator training

Behavioral: LapSimGyn training until expert proficiency level is reached

2

ACTIVE COMPARATOR

Traditional Clinical education at operating room

Behavioral: Traditional clinical education

Interventions

LapSimGyn training until expert proficiency level is reachedBEHAVIORAL

Two consecutive simulations reaching predefined expert level

1
Traditional clinical educationBEHAVIORAL
2

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Advanced laparoscopic experience
  • Previous training in simulator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • 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. doi: 10.1080/01421590500046924.

    PMID: 16147767BACKGROUND

  • Larsen CR, Soerensen JL, Grantcharov TP, Dalsgaard T, Schouenborg L, Ottosen C, Schroeder TV, Ottesen BS. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial. BMJ. 2009 May 14;338:b1802. doi: 10.1136/bmj.b1802.

    PMID: 19443914DERIVED

Study Officials

  • Bent Ottesen, MD Dr.Sci

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2006

First Posted

April 6, 2006

Study Start

August 1, 2006

Study Completion

August 1, 2007

Last Updated

August 30, 2007

Record last verified: 2007-08

Locations

DK(1)