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- Ensaio Clínico NCT01618994
Validation Study for Robotic Surgery Simulator
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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New Jersey
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Morristown, New Jersey, Estados Unidos, 07960
- Morristown Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Must not have performed a da Vinci assisted surgery
Exclusion Criteria:
- prior experience on the da Vinci system or the robotic simulator
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
Expert Surgeons
Gynecologic robotic surgeons, each averaging >75 robotic cases per year
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All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
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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
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Control Surgeons
Gynecologic surgeons with full robotic privileges but were not averaging more than 2 cases a month and had never used the simulator
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All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Surgical Time
Prazo: At end of cervical amputation
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As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation
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At end of cervical amputation
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Blood Loss
Prazo: 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
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End of cervical amputation
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Surgical Skill Rating
Prazo: Within a month of the performed surgery
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All procedures will be recorded and rated by a blinded investigator according to a standardized surgical skills evaluation sheet
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Within a month of the performed surgery
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Surgeon Console Biometrics
Prazo: during surgery
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As measured by controller movements and grip
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during surgery
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Novice Robotic Surgeon Data
Prazo: Within a month of the performed surgery
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Descriptive Operative data of surgeons who did not participate in robotic simulator training
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Within a month of the performed surgery
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Charbel Salamon, MD, Atlantic Health System
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R11-01-018
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Prolapso de órgãos pélvicos
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Medical University of ViennaRecrutamentoProlapso de órgãos pélvicos | Cistocele | Prolapso Vaginal | Cistocele, linha média | Prolaps BexigaÁustria