Clinical CompetencePhase 2/3NCT00311792
Transfer of Skills From VR-Trainer to Operation Room
A Phase 2/3 study testing LapSimGyn training until expert proficiency level is reached and Traditional clinical education in people with Clinical Competence, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Competence
- What is being tested?
- LapSimGyn training until expert proficiency level is reached and Traditional clinical education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2006to Aug 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gyn/obs trainee 1.-2. year, with no experience from advanced laparoscopy
Who cannot join
- Advanced laparoscopic experience
- Previous training in simulator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- Clinical Competence
- Being tested
- LapSimGyn training until expert proficiency level is reached, Traditional clinical education
- Keywords
- training, teaching, curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapSimGyn training until expert proficiency level is reachedBehavioural
Two consecutive simulations reaching predefined expert level
Traditional clinical educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Simulator training Receives: Behavioral: LapSimGyn training until expert proficiency level is reached |
| 2 | Active comparator | Traditional Clinical education at operating room Receives: Behavioral: Traditional clinical education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating Scale Score
Measured: 1 day
Secondary outcomes (1)
Time used to perform operation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startAug 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Clinical CompetenceStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Bent Ottesen, MD Dr.Sci, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311792
- Sponsor's protocol ID
- KF 01283756
- Other IDs
- 959587647
- Status last verified
- Aug 2007
- First submitted
- 5 Apr 2006
- Last updated
- 30 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1080/01421590500046924.
PubMed 16147767Larsen 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.
PubMed 19443914
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer of Skills From LapSimGyn VR-Simulator to a Laparoscopic Salpingectomy
- ClinicalTrials.gov ID
- NCT00311792
- Acronym / sponsor ID
- KF 01283756
- Conditions
- Clinical Competence
- Keywords
- training, teaching, curriculum
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 6 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: LapSimGyn training until expert proficiency level is reachedSimulator training |
| 2 | Active comparator | Behavioral: Traditional clinical educationTraditional Clinical education at operating room |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Gyn/obs trainee 1.-2. year, with no experience from advanced laparoscopy
Key exclusion criteria (2 listed)
- Advanced laparoscopic experience
- Previous training in simulator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LapSimGyn training until expert proficiency level is reachedTwo consecutive simulations reaching predefined expert level | Behavioural | 1 |
| Traditional clinical education | Behavioural | 2 |
Primary outcome
Rating Scale Score
Time frame: 1 day
1 secondary outcome
Time used to perform operation
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2007.
- Background: PubMed 16147767Issenberg 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.
- Derived from this study: PubMed 19443914Larsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bent Ottesen, MD Dr.Sci study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing LapSimGyn training until expert proficiency level is reached and Traditional clinical education in people with Clinical Competence, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rating Scale Score (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00311792, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2007.