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临床试验/NCT01618994
NCT01618994已完成不适用

Validation Study for Robotic Surgery Simulator

Atlantic Health System1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Surgical Time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Must not have performed a da Vinci assisted surgery

排除标准

  • •prior experience on the da Vinci system or the robotic simulator

结局指标

主要结局

Surgical Time

时间窗: At end of cervical amputation

As measured by time spent on the surgeon console from beginning of hysterectomy until the end of cervical amputation

次要结局

  • Blood Loss(End of cervical amputation)
  • Surgical Skill Rating(Within a month of the performed surgery)
  • Surgeon Console Biometrics(during surgery)
  • Novice Robotic Surgeon Data(Within a month of the performed surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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