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Validation Study for Robotic Surgery Simulator

8 de junio de 2017 actualizado por: Atlantic Health System
A study to determine whether completing a rigorous simulation protocol could provide novice robotic surgeons with actual advanced surgical skills in an operating room setting.

Descripción general del estudio

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:

  1. Blood loss- as measured by the blood suctioned into the canister throughout the hysterectomy and at the end of the amputation discounting irrigation volume.
  2. Surgical skill rating- All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet.
  3. Surgeon console biometrics- As measured by controller movements and grips
  4. 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

De observación

Inscripción (Actual)

14

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New Jersey
      • Morristown, New Jersey, Estados Unidos, 07960
        • Morristown Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Gynecologic surgeons with no robotic experience

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Charbel Salamon, MD, Atlantic Health System

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2011

Finalización primaria (Actual)

1 de enero de 2012

Finalización del estudio (Actual)

1 de enero de 2012

Fechas de registro del estudio

Enviado por primera vez

11 de junio de 2012

Primero enviado que cumplió con los criterios de control de calidad

12 de junio de 2012

Publicado por primera vez (Estimar)

14 de junio de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de junio de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

8 de junio de 2017

Última verificación

1 de junio de 2017

Más información

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. .

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