- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02411747
Simulation-based Training for Flexible Cystoscopy - a Patient Transfer Randomized Trial
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Testing+endoscopic simulation training
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.
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|
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Comparador activo: Oral lecture+endoscopic simulation training
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Global Rating Scale
Periodo de tiempo: 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.
|
Two to four weeks after day of simulation training
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sarah H. Bube, Cand.med., Rigshospitalet, Denmark
Publicaciones y enlaces útiles
Publicaciones Generales
- Brydges 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.
- Kromann 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.
- 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.
- Schout 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.
- Persoon 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.
- Bube 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- H-4-2014-122
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