- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02986217
The Effect of Structured Feedback on Live Surgical Performance (CSATS)
The Effect of Structured Feedback on Live Surgical Performance: A Single-Blind Randomized Control Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The American Association of Gynecologic Laparoscopists (AAGL) and Accreditation Council of Graduate Medical Education (ACGME) have endeavored to implement structure and standardization for the fellowship in minimally invasive gynecologic surgical programs (FMIGS) and obstetric and gynecology residency programs respectively. Educational objectives are explicitly delineated. Though the fellowship and residency educational objectives are well rounded, and include the development of skills to become leaders and educators in the field of minimally invasive gynecologic surgery (MIGS) and general obstetrics and gynecology, one of the main objective of the fellowship and residency training is the attainment of surgical skill. This is ensured by a requirement for a breadth of surgical exposure including vaginal surgery, hysteroscopy, traditional laparoscopy, management of surgical complications, minimally invasive hysterectomy, urogynecologic procedures, gastrointestinal surgery, urinary tract surgery, reproductive surgery, and the surgical management of common gynecologic conditions such as endometriosis. Minimum case requirements have been implemented to provide guidance for FMIGS and residency programs. In addition, trainees are required to log surgical cases and this information is utilized for FMIGS and residency program site inspections as well as for feedback of surgical competency. Despite standardization efforts by the AAGL and ACGME, the FMIGS and obstetric and gynecology residency curriculums are still in evolution. There is likely still great variation in surgical exposure between programs. In addition, though regular feedback is a requirement of training programs, the process is likely unstructured and subjective; based on case logs, self-assessments, and feedback by faculty surgeons. There is thus a critical need to develop a standardized, objective, timely, and actionable feedback methodology to facilitate program oversight and ensure FMIGS fellows and obstetrics and gynecology residents are achieving surgical competency throughout their training. In the absence of such structured feedback models, it will remain difficult to optimize FMIGS fellowship and obstetrics and gynecology resident training, and provide objective measurements of the impact of such training on surgical performance and patient outcomes. .
The long-term goal of this study is to assist in developing methods for surgical assessment that facilitate program oversight, allow fellows, residents, and program directors to identify specific skill sets in need of improvement, monitor progress in skill acquisition, and clearly and objectively document achievement of milestones throughout training. The study's overall objective is to determine how consistent structured feedback using crowd sourcing impacts time to complete a task as well as surgical performance as measured by GOALS and GEARS scores. The central hypothesis is that fellows and residents who receive consistent structured feedback over a sustained period of time will have shorter task times, overall improved performance, and greater satisfaction than fellows and residents receiving traditional feedback. The rationale for this work is that it will provide focus and supportive data for large-scale studies of surgical skill acquisition and development.
This study seeks to establish the effect of regular structured feedback on surgical performance using crowd sourced video assessments with GOALS and GEARS through a randomized controlled trial. The study hypothesizes regular structured assessment will lead to a greater measurable improvement in performance, as defined by change and GOALS and GEARS scores, than will traditional feedback methods as well as time to complete a specific procedure.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- current position as a resident in obstetrics and gynecology in a year of training where laparoscopic or robotic hysterectomy is regularly performed -- OR -- FMIGS Fellow regularly performing laparoscopic or robotic hysterectomy
- participants must be between 18 and 60 years of age
Exclusion Criteria:
- persons not in a position as a resident in obstetrics and gynecology in a year of training where laparoscopic or robotic hysterectomy is regularly performed -- OR -- persons not a FMIGS Fellow regularly performing laparoscopic or robotic hysterectomy
- participants younger than 18 and older than 60 years of age
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Control Group
Participants randomized to the Control Group will submit a video of surgical performance of vaginal cuff closure during a hysterectomy.
Subjects in the control group will receive traditional feedback methods as determined by each participant's training program.
Subjects in the control group will repeat the process of video submission of the same procedure using the same surgical approach every 2 weeks for 2 cycles.
At 6 weeks, participants will submit a final video performing vaginal cuff closure during hysterectomy.
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Experimental: Experimental Group
Participants randomized to the Experimental Group will submit a video of surgical performance of vaginal cuff closure during a hysterectomy.
Subjects in the experimental group will then receive feedback within 5 business days of video submission and repeat the process of video submission of the same procedure using the same surgical approach every 2 weeks for 2 cycles.
At 6 weeks, participants will submit a final video performing vaginal cuff closure during hysterectomy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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difference in mean time needed to perform cuff closure during hysterectomy
Periodo de tiempo: 6 weeks post study enrollment
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The difference in mean time (measured in minutes) needed to perform vaginal cuff closure during hysterectomy between subjects in the control versus experimental groups.
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6 weeks post study enrollment
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difference in mean surgical performance score
Periodo de tiempo: 6 weeks post study enrollment
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The difference in mean surgical performance score of a vaginal cuff closure at the time of hysterectomy between participants in the control versus experimental groups.
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6 weeks post study enrollment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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difference in trainee satisfaction with feedback method
Periodo de tiempo: 6 weeks post study enrollment
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the difference in mean satisfaction score between participants in the control versus experimental groups
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6 weeks post study enrollment
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
- 101614
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .