- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01618994
Validation Study for Robotic Surgery Simulator
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Objective: To determine whether a group of surgeons otherwise naive to robotic techniques could demonstrate proficiency during their first robotic supracervical hysterectomy having only received simulator and pig lab training.
Primary outcome measure: As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation.
Secondary Outcome measures:
- Blood loss- as measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume.
- Surgical skill rating- All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet.
- Surgeon console biometrics- As measured by controller movements and grips
- Novice robotic surgeon data: Descriptive Operative data of surgeons who did not participate in robotic simulator training.
Methods: To create the simulator protocol, 5 robotic surgeons (each averaging >75 robotic cases per year) performed all 28 simulation modules available on the da Vinci Skills Simulator. To establish "expert benchmarks", they picked the 10 simulator modules they thought were most beneficial to robotic novices', and they performed each of these 10 modules to the best of their ability >5 times. The data was used to create benchmarks in which all parameters of these 10 modules were taken into account (i.e. not just the time to completion). Thus the "Morristown Protocol" was established- whereby successful completion of the protocol required passing every parameter of all 10 simulator modules at the expert level.
We then recruited community board-certified OB-GYN's who were completely naive to robotics and offered them full robotic training free-of-charge as long as they could pass the "Morristown Protocol" as their very first step in the training process. These "study surgeons" were given 24/7 access to the da Vinci Skills Simulator and simply asked to complete the protocol at their own pace. Within a week of doing so, they went through the standardized Intuitive Surgical pig lab and then performed their first ever robotic surgery- a supracervical hysterectomy- as our main outcome measure. These cases were performed using the dual-console daVinci system with one of the senior authors on the other console ready to step in if necessary.
Two sets of comparative benchmarks for this surgical procedure has been established. Our "expert surgeons" each performed supracervical hysterectomies for the study- as did a group of "control surgeons". These "control surgeons" had full robotic privileges but were not averaging more than 2 cases per month and had never used the simulator. Operative time, EBL, and a blinded skill assessment (of videos) were compared for all cases among the 3 surgeon groups using t-tests.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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New Jersey
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Morristown, New Jersey, Estados Unidos, 07960
- Morristown Medical Center
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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
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Must not have performed a da Vinci assisted surgery
Exclusion Criteria:
- prior experience on the da Vinci system or the robotic simulator
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Expert Surgeons
Gynecologic robotic surgeons, each averaging >75 robotic cases per year
|
All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
|
|
Study Surgeons
Gynecologic surgeons who are completely naive to robotics
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All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
|
|
Control Surgeons
Gynecologic surgeons with full robotic privileges but were not averaging more than 2 cases a month and had never used the simulator
|
All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Surgical Time
Periodo de tiempo: At end of cervical amputation
|
As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation
|
At end of cervical amputation
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Blood Loss
Periodo de tiempo: End of cervical amputation
|
As measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume
|
End of cervical amputation
|
|
Surgical Skill Rating
Periodo de tiempo: Within a month of the performed surgery
|
All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet
|
Within a month of the performed surgery
|
|
Surgeon Console Biometrics
Periodo de tiempo: during surgery
|
As measured by controller movements and grip
|
during surgery
|
|
Novice Robotic Surgeon Data
Periodo de tiempo: Within a month of the performed surgery
|
Descriptive Operative data of surgeons who did not participate in robotic simulator training
|
Within a month of the performed surgery
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Charbel Salamon, MD, Atlantic Health System
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R11-01-018
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