EducationNCT00435630
Documenting a Learning Curve and Test-retest Reliability of a Virtual Reality Training Simulator in Laparoscopic Surgery
A study testing LapSim training in people with Education, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to determine the learning curve for each of seven tasks in a virtual reality laparoscopic simulator by medical students. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Education
- What is being tested?
- LapSim training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Aug 2008
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical students, years 1 through 4 are eligible.
- No prior clinical experience with laparoscopic surgery as the assistant surgeon.
- No prior simulation training (mechanical, PC-based or otherwise).
Who cannot join
- Persons who are not medical students.
- Medical students with prior clinical experience with laparoscopic surgery as the assistant surgeon.
- Medical students with prior simulation training (mechanical, PC-based or otherwise).
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University College of Physicians and Surgeons
New York, New York, 10032
About this study
The purpose of this study is to determine the learning curve for each of seven tasks in a virtual reality laparoscopic simulator by medical students.
Read the detailed description
Developing objective methodology for assessing technical skill is paramount to superior surgical training. Alternatives to the traditional apprenticeship model of surgical training are necessary in today's emphasis on cost containment and professional competency.
Metrics are widely employed in virtual environments and provide a yardstick for performance measurement. The current method of defining metrics for medical simulation remains more an art than a science. Many studies have demonstrated that trainees who practice laparoscopic skills in a simulated environment will improve their mastery of those skills when tested in that same environment. Fewer studies have been able to document the learning curve for mastery of tasks in a virtual reality simulator. This study will investigate the learning curve for tasks in a virtual reality laparoscopic simulator.
- Conditions
- Education
- Being tested
- LapSim training
- Keywords
- Education, Virtual Reality, Laparoscopic Surgery, Learning Curve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapSim trainingOther
complete curriculum training on LapSim surgical simulator
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Completing simulator training sessions Receives: Other: LapSim training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish learning curve for each of seven tasks on the simulator.
For each of the module seven modules, the computer automatically measures set parameters. Each measured parameter that is recorded in the simulator will be used in data analysis.
Measured: 6 months
Secondary outcomes (1)
Establish test-retest reliability for each of seven tasks on the simulator.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startJul 2004
- Primary completionJan 2005
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Fowler, Columbia University
- Investigators
- Dennis L Fowler, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435630
- Sponsor's protocol ID
- AAAA7372
- Status last verified
- Nov 2012
- First submitted
- 14 Feb 2007
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Documenting a Learning Curve and Test-retest Reliability of a Virtual Reality Training Simulator in Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT00435630
- Acronym / sponsor ID
- AAAA7372
- Conditions
- Education
- Keywords
- Education, Virtual Reality, Laparoscopic Surgery, Learning Curve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Feb 2007 (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 of this study is to determine the learning curve for each of seven tasks in a virtual reality laparoscopic simulator by medical students.
Detailed description
Developing objective methodology for assessing technical skill is paramount to superior surgical training. Alternatives to the traditional apprenticeship model of surgical training are necessary in today's emphasis on cost containment and professional competency.
Metrics are widely employed in virtual environments and provide a yardstick for performance measurement. The current method of defining metrics for medical simulation remains more an art than a science. Many studies have demonstrated that trainees who practice laparoscopic skills in a simulated environment will improve their mastery of those skills when tested in that same environment. Fewer studies have been able to document the learning curve for mastery of tasks in a virtual reality simulator. This study will investigate the learning curve for tasks in a virtual reality laparoscopic simulator.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: LapSim trainingCompleting simulator training sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical students, years 1 through 4 are eligible.
- No prior clinical experience with laparoscopic surgery as the assistant surgeon.
- No prior simulation training (mechanical, PC-based or otherwise).
Key exclusion criteria (3 listed)
- Persons who are not medical students.
- Medical students with prior clinical experience with laparoscopic surgery as the assistant surgeon.
- Medical students with prior simulation training (mechanical, PC-based or otherwise).
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 |
|---|---|---|
| LapSim trainingcomplete curriculum training on LapSim surgical simulator | Other | 1 |
Primary outcome
Establish learning curve for each of seven tasks on the simulator.
Time frame: 6 months
For each of the module seven modules, the computer automatically measures set parameters. Each measured parameter that is recorded in the simulator will be used in data analysis.
1 secondary outcome
Establish test-retest reliability for each of seven tasks on the simulator.
Time frame: 6 months
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 21 Nov 2012.
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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.
Dennis L Fowler, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LapSim training in people with Education, run by Columbia University at 1 site in United States.
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 3 inclusion and 3 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 21 Nov 2012. 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 United States. 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.
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?
Establish learning curve for each of seven tasks on the simulator. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2012.