- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01875679
Comprehensive Surgical Coaching
Surgical Coaching -Using Error Debriefing, Behavioral Modeling and Error Recognition to Enhance Surgical Skill
Simulation in surgical skills training is widely accepted as a necessary step to improve surgical training outside the operating room. Simulation predominately focuses on teaching a specific task or procedure. Once this task is acquired ongoing optimization of technique is desirable. Commonly ongoing skills assessment occurs in the form of peer feedback throughout training rotations. This feedback is frequently subjective and of variable educational use. Identifying ongoing technical training needs and enabling personalized objective feedback represents an important training concept that has not yet been formally used in resident training.
The specific goal of this study is to prove the effect of a comprehensive surgical coaching (CSC) approach which combines concepts of behavior modeling training, task debriefing and error recognition to improve overall surgical technique without additional technical skills training.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Design The study design is a randomized, controlled trial involving evaluation of a study and a conventionally trained group at pretest and posttest.
Participants The study and control groups will consist of senior surgical residents (PGY 3-5) and surgical fellows involved in minimally invasive surgery (MIS).
Inclusion: Since concurrent operative training in the operating room (OR) in the technique of MIS is a prerequisite for this study, only residents and fellows on rotations with a practice focus on MIS during the time period of the study will be eligible for participation.
Exclusion: Individuals with severe illnesses precluding performance in the OR will not be included.
Outcome measures: Surgical performance will be assessed using a global rating scale as well as through tabulation of observed intraoperative technical errors. Primary outcome measure is surgical skill level before and after targeted training.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5B 1W8
- St. Michael's Hospital
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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:
- surgical residents and fellows on rotations with a practice focus on minimally invasive surgery during the time period of the study
Exclusion Criteria:
- individuals with severe illnesses precluding performance in the OR
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Conventional residency training
This group will continue their regular surgical training without any specific intervention.
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Surgical training as per participant's residency program
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Experimental: Comprehensive Surgical Coaching (SCS)
The participants will receive an analysis of the technical performance as observed on baseline recordings of the index procedure.
Training needs will be identified and a personalized coaching concept will be designed.
Coaching sessions will include video debriefing of the participant's performance (sample recordings will be submitted by the participant during the sessions) and video assisted behavioral modeling using examples of good and poor technical performance.
Coaching will also target increasing awareness of weaknesses and potential pitfalls in surgical technical task execution (error recognition).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Surgical Technical Skill
Periodo de tiempo: After 8 weeks of participation
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Surgical skill measures as recorded on a procedure specific global rating scale, Objective Structured Assessment of Technical Skills (OSATS) and bariatric OSATS (BOSATS) scores and by tabulation of technical errors, Generic Error Rating Tool (GERT) observed during the index procedures.
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After 8 weeks of participation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Learning curves
Periodo de tiempo: Throughout 8 weeks of participation
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Development of skill and reduction of errors will be assessed in relation to number of procedures performed to obtain learning curves for each study group. Surgical technical skill will be assessed by OSATS and BOSATS scales, errors will be recorded by GERT checklist |
Throughout 8 weeks of participation
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Teodor P Grantcharov, MD. PhD, St. Michael's Hospital (Toronto, Canada)
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 (Estimar)
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
- CSC2013
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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