Group IdentificationNCT02043327
Simulation Based Training in Colonoscopy
An observational study of Group Identification, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of this study is to create simulation-based tests with credible pass/fail-standards for two different fidelities of colonoscopy models 1. virtual reality simulator 2. physical model simulator To create pass/ fail standards for certification Read more about this study
- Who is it for?
- Ages 28 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Group Identification
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2012to Nov 2013
- Phase
- Observational
- 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 28 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Experienced: 10 consultants of gastroenterology with experience in Colonoscopy (>350 procedures) Novices: 15 fellows of gastroenterology with limited experience in Colonoscopy (<2 procedures)
Who may be able to join
- Experienced endoscopists :
- Having performed >350 colonoscopy procedures
- Novice endoscopists:
- First or second year of fellowship in gastroenterology Having performed less than 3 colonoscopies
Who cannot join
- Experienced endoscopists:
- Prior simulator training
- Novice endoscopists:
- Prior simulator training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simulation-based Training for Colonoscopy: Establishing Criteria for Competency
The aim of this study is to create simulation-based tests with credible pass/fail-standards for two different fidelities of colonoscopy models
- virtual reality simulator
- physical model simulator To create pass/ fail standards for certification
Read the detailed description
Twenty-five physicians (10 consultants with endoscopic experience and 15 fellows in the first year of fellowship without endoscopic experience) will be tested twice on each of the two different simulator models.
Metrics with discriminatory ability will be identified for both modalities. Reliability will be determined A pass/ fail standard will be determined and the concequences explored.
- Conditions
- Group Identification
- Keywords
- Colonoscopy, assessment, certification,, simulation,, standard setting
- Medical subject headings
- Social Identification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experienced in Colonoscopy | two tests on two different modalities of colonoscopy simulators | |
| Novices in colonoscopy | Two tests on each of trw colonoscopy simulators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metrics with discriminatory ability measuring colonoscopy competence
Each participant perform two tests on each model within the same day.
Measured: tests were carried out in one day per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group IdentificationStudies 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
- Observational
- Observational model
- Case-control
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Preisler, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Louise Preisler, MD, Principal investigator, Rigshospitalet, Copenhagen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043327
- Sponsor's protocol ID
- PassFailstudy
- Status last verified
- Jan 2014
- First submitted
- 10 Jan 2014
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-based Training for Colonoscopy: Establishing Criteria for Competency
- ClinicalTrials.gov ID
- NCT02043327
- Acronym / sponsor ID
- PassFailstudy
- Conditions
- Group Identification
- Keywords
- Colonoscopy, assessment, certification,, simulation,, standard setting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Jan 2014 (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 aim of this study is to create simulation-based tests with credible pass/fail-standards for two different fidelities of colonoscopy models
- virtual reality simulator
- physical model simulator To create pass/ fail standards for certification
Detailed description
Twenty-five physicians (10 consultants with endoscopic experience and 15 fellows in the first year of fellowship without endoscopic experience) will be tested twice on each of the two different simulator models.
Metrics with discriminatory ability will be identified for both modalities. Reliability will be determined A pass/ fail standard will be determined and the concequences explored.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experienced in Colonoscopy | – | –two tests on two different modalities of colonoscopy simulators |
| Novices in colonoscopy | – | –Two tests on each of trw colonoscopy simulators |
Who may qualify
- Ages
- 28 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Experienced: 10 consultants of gastroenterology with experience in Colonoscopy (>350 procedures) Novices: 15 fellows of gastroenterology with limited experience in Colonoscopy (<2 procedures)
Key inclusion criteria (4 listed)
- Having performed >350 colonoscopy procedures
- First or second year of fellowship in gastroenterology Having performed less than 3 colonoscopies
Key exclusion criteria (4 listed)
- Prior simulator training
- Prior simulator training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metrics with discriminatory ability measuring colonoscopy competence
Time frame: tests were carried out in one day per participant
Each participant perform two tests on each model within the same 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 23 Jan 2014.
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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.
Louise Preisler, MD principal investigator
Rigshospitalet, Copenhagen, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group Identification, 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 4 inclusion and 4 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 23 Jan 2014. 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.
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?
Metrics with discriminatory ability measuring colonoscopy competence (time frame: tests were carried out in one day per participant). 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 23 Jan 2014.