EducationNCT02411747
Simulation-based Training for Flexible Cystoscopy - a Patient Transfer Randomized Trial
A study testing Testing and Directed self-regulated simulation training in people with Education, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Simulation training in surgical education in Urology specialist training in flexible cystoscopy has been demonstrated a valid and efficient learning instrument. The classical setup with a medical expert introducing the novices to the theoretical background and technics of the procedure is time-consuming and expensive. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Education
- What is being tested?
- Testing and Directed self-regulated simulation training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Senior medical students
- Novices in endoscopic procedures
- Written and oral consent
Who cannot join
- Performed a endoscopic procedure independently
- Lack of language skills
- Lack of written and oral consent
About this study
Simulation training in surgical education in Urology specialist training in flexible cystoscopy has been demonstrated a valid and efficient learning instrument. The classical setup with a medical expert introducing the novices to the theoretical background and technics of the procedure is time-consuming and expensive. Directed self-regulated simulation training (DSR) is a validated method in simulation training. The power of testing in DSR and flexible cystoscopy is to our knowledge not known. We introduced a setup in which the novices started by training in a directed self-regulated simulation training environment and informed them that they would be tested by a medical expert afterwards. The intervention group novices were given only written theoretical information and anatomical pictures. The control group were first given a classical oral theoretical introduction by a medical expert and secondly did DSR training. We tested the outcome of the intervention by a validated rating scale for flexible cystoscopy. The novices in both the control and intervention group were tested on patients prescribed a flexible cystoscopy and evaluated by a specialist in Urology.
The main hypothesis was that testing in relation to DSR would result in higher scores on a validated scale when performing a flexible cystoscopy on a patient evaluated by a specialist in Urology compared to a group having a oral lecture before DSR.
- Conditions
- Education
- Being tested
- Testing, Directed self-regulated simulation training
- Keywords
- Medical, Urology, Randomized Controlled Trial, Endoscopy, Cystoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestingBehavioural
Directed self-regulated simulation trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Testing+endoscopic simulation training | Experimental | Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with a expert in the procedure. Total max time: 2 hours. Receives: Behavioral: Testing; Behavioral: Directed self-regulated simulation training |
| Oral lecture+endoscopic simulation training | Active comparator | Endoscopic training in flexible cystoscopy by directed self-regulated training, max. time cap 1h45min after a 15 minute oral theoretical lecture by a expert in the procedure. Total max. time: 2 hours. Receives: Behavioral: Directed self-regulated simulation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Rating Scale
The subjects perform a flexible cystoscopy on two different patients and each cystoscopy are being scored by a specialist in Urology (the same in the entire study) using a validated scoring system for flexible cystoscopy, the Global Rating Scale. A previously validated assessment tool, Global Rating Scale (GRS) was used to assess the cystoscopy procedures. GRS is composed of five different parameters: respect for tissue, time and motion, handling of endoscope, flow of procedure, forward planning, and knowledge of procedure. Each parameter is assessed on a five point Likert scale with a minimum of one to maximum of five, giving the total GRS score a range of five to 25. At our institution we have defined a GRS score of three in each parameter (minimum total GRS of 15) as a minimum passing standard.
Measured: Two to four weeks after day of simulation training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for EducationStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Hjartbro Bube, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Sarah H. Bube, Cand.med., Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411747
- Sponsor's protocol ID
- H-4-2014-122
- Status last verified
- Jul 2019
- First submitted
- 31 Mar 2015
- Last updated
- 22 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Matsumoto ED, Hamstra SJ, Radomski SB, Cusimano MD. A novel approach to endourological training: training at the Surgical Skills Center. J Urol. 2001 Oct;166(4):1261-6. doi: 10.1016/s0022-5347(05)65749-7.
PubMed 11547054Schout BM, Ananias HJ, Bemelmans BL, d'Ancona FC, Muijtjens AM, Dolmans VE, Scherpbier AJ, Hendrikx AJ. Transfer of cysto-urethroscopy skills from a virtual-reality simulator to the operating room: a randomized controlled trial. BJU Int. 2010 Jul;106(2):226-31; discussion 231. doi: 10.1111/j.1464-410X.2009.09049.x. Epub 2009 Nov 12.
PubMed 19912184Kromann CB, Jensen ML, Ringsted C. The effect of testing on skills learning. Med Educ. 2009 Jan;43(1):21-7. doi: 10.1111/j.1365-2923.2008.03245.x.
PubMed 19140995Brydges R, Nair P, Ma I, Shanks D, Hatala R. Directed self-regulated learning versus instructor-regulated learning in simulation training. Med Educ. 2012 Jul;46(7):648-56. doi: 10.1111/j.1365-2923.2012.04268.x.
PubMed 22691145Persoon MC, Schout BM, Muijtjens AM, Hendrikx AJ, Witjes JA, Scherpbier AJ. The effect of a low-fidelity model on cystoscopic skill training: a single-blinded randomized controlled trial. Simul Healthc. 2010 Aug;5(4):213-8. doi: 10.1097/SIH.0b013e3181e1b73d.
PubMed 21330799Bube S, Dagnaes-Hansen J, Mahmood O, Rohrsted M, Bjerrum F, Salling L, Hansen RB, Konge L. Simulation-based training for flexible cystoscopy - A randomized trial comparing two approaches. Heliyon. 2020 Jan 3;6(1):e03086. doi: 10.1016/j.heliyon.2019.e03086. eCollection 2020 Jan.
PubMed 31922043
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-based Training for Flexible Cystoscopy - a Patient Transfer Randomized Trial
- ClinicalTrials.gov ID
- NCT02411747
- Acronym / sponsor ID
- H-4-2014-122
- Conditions
- Education
- Keywords
- Medical, Urology, Randomized Controlled Trial, Endoscopy, Cystoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Posted 15 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Simulation training in surgical education in Urology specialist training in flexible cystoscopy has been demonstrated a valid and efficient learning instrument. The classical setup with a medical expert introducing the novices to the theoretical background and technics of the procedure is time-consuming and expensive. Directed self-regulated simulation training (DSR) is a validated method in simulation training. The power of testing in DSR and flexible cystoscopy is to our knowledge not known. We introduced a setup in which the novices started by training in a directed self-regulated simulation training environment and informed them that they would be tested by a medical expert afterwards. The intervention group novices were given only written theoretical information and anatomical pictures. The control group were first given a classical oral theoretical introduction by a medical expert and secondly did DSR training. We tested the outcome of the intervention by a validated rating scale for flexible cystoscopy. The novices in both the control and intervention group were tested on patients prescribed a flexible cystoscopy and evaluated by a specialist in Urology.
The main hypothesis was that testing in relation to DSR would result in higher scores on a validated scale when performing a flexible cystoscopy on a patient evaluated by a specialist in Urology compared to a group having a oral lecture before DSR.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testing+endoscopic simulation training | Experimental | Behavioral: Testing, Behavioral: Directed self-regulated simulation trainingEndoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with a expert in the procedure. Total max time: 2 hours. |
| Oral lecture+endoscopic simulation training | Active comparator | Behavioral: Directed self-regulated simulation trainingEndoscopic training in flexible cystoscopy by directed self-regulated training, max. time cap 1h45min after a 15 minute oral theoretical lecture by a expert in the procedure. Total max. time: 2 hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Senior medical students
- Novices in endoscopic procedures
- Written and oral consent
Key exclusion criteria (3 listed)
- Performed a endoscopic procedure independently
- Lack of language skills
- Lack of written and oral consent
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 |
|---|---|---|
| Testing | Behavioural | Testing+endoscopic simulation training |
| Directed self-regulated simulation training | Behavioural | Oral lecture+endoscopic simulation training, Testing+endoscopic simulation training |
Primary outcome
Global Rating Scale
Time frame: Two to four weeks after day of simulation training
The subjects perform a flexible cystoscopy on two different patients and each cystoscopy are being scored by a specialist in Urology (the same in the entire study) using a validated scoring system for flexible cystoscopy, the Global Rating Scale. A previously validated assessment tool, Global Rating Scale (GRS) was used to assess the cystoscopy procedures. GRS is composed of five different parameters: respect for tissue, time and motion, handling of endoscope, flow of procedure, forward planning, and knowledge of procedure. Each parameter is assessed on a five point Likert scale with a minimum of one to maximum of five, giving the total GRS score a range of five to 25. At our institution we have defined a GRS score of three in each parameter (minimum total GRS of 15) as a minimum passing standard.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11547054Matsumoto ED, Hamstra SJ, Radomski SB, Cusimano MD. A novel approach to endourological training: training at the Surgical Skills Center. J Urol. 2001 Oct;166(4):1261-6. doi: 10.1016/s0022-5347(05)65749-7.
- Background: PubMed 19912184Schout BM, Ananias HJ, Bemelmans BL, d'Ancona FC, Muijtjens AM, Dolmans VE, Scherpbier AJ, Hendrikx AJ. Transfer of cysto-urethroscopy skills from a virtual-reality simulator to the operating room: a randomized controlled trial. BJU Int. 2010 Jul;106(2):226-31; discussion 231. doi: 10.1111/j.1464-410X.2009.09049.x. Epub 2009 Nov 12.
- Background: PubMed 19140995Kromann CB, Jensen ML, Ringsted C. The effect of testing on skills learning. Med Educ. 2009 Jan;43(1):21-7. doi: 10.1111/j.1365-2923.2008.03245.x.
- Background: PubMed 22691145Brydges R, Nair P, Ma I, Shanks D, Hatala R. Directed self-regulated learning versus instructor-regulated learning in simulation training. Med Educ. 2012 Jul;46(7):648-56. doi: 10.1111/j.1365-2923.2012.04268.x.
- Background: PubMed 21330799Persoon MC, Schout BM, Muijtjens AM, Hendrikx AJ, Witjes JA, Scherpbier AJ. The effect of a low-fidelity model on cystoscopic skill training: a single-blinded randomized controlled trial. Simul Healthc. 2010 Aug;5(4):213-8. doi: 10.1097/SIH.0b013e3181e1b73d.
- Derived from this study: PubMed 31922043Bube S, Dagnaes-Hansen J, Mahmood O, Rohrsted M, Bjerrum F, Salling L, Hansen RB, Konge L. Simulation-based training for flexible cystoscopy - A randomized trial comparing two approaches. Heliyon. 2020 Jan 3;6(1):e03086. doi: 10.1016/j.heliyon.2019.e03086. eCollection 2020 Jan.
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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.
Sarah H. Bube, Cand.med. principal investigator
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
A study testing Testing and Directed self-regulated simulation training in people with Education, run by Copenhagen University Hospital, Rigshospitalet.
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 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 15 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Global Rating Scale (time frame: Two to four weeks after day of simulation training). 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 NCT02411747, which also lists 6 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 22 Jul 2019.