Simulation-based Training for Flexible Cystoscopy - a Patient Transfer Randomized Trial

Study Overview
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Brief Summary
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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.

Official Title
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Simulation-based Training for Flexible Cystoscopy - a Patient Transfer Randomized Trial

Conditions
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Education

Intervention / Treatment
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* Behavioral: Testing
* Behavioral: Directed self-regulated simulation training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Senior medical students Novices in endoscopic procedures Written and oral consent Exclusion Criteria: Performed a endoscopic procedure independently Lack of language skills Lack of written and oral consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testing+endoscopic simulation training<br>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. | Behavioral: Testing<br> <br> Behavioral: Directed self-regulated simulation training<br> <br> |
| Active Comparator: Oral lecture+endoscopic simulation training<br>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. | Behavioral: Directed self-regulated simulation training<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Two to four weeks after day of simulation training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical, Urology, Randomized Controlled Trial, Endoscopy, Cystoscopy