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临床试验/NCT02370407
NCT02370407已完成不适用

Assessment of the Transferability of Skills From Robotic to Laparoscopic Simulation Platforms in Surgical Skill Naive Participants

Johns Hopkins University0 个研究点目标入组 40 人开始时间: 2014年11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
40
主要终点
Global Rating Scale Score on the Laparoscopic Task

研究概览

简要总结

This is a randomized controlled trial that will randomize 40 surgical skill naive medical students to practice on a robotic simulator or laparoscopic simulator after first completing a baseline evaluation on both surgical simulation platforms. Medical students will be evaluated again after 10 practice sessions on the laparoscopic or robotic platforms to assess transferability of skills between the surgical simulation platforms.

详细描述

This is a randomized controlled trial that will randomize medical students to practice on a robotic simulator or a laparoscopic simulator. The investigators will first obtain baseline data by having the study participants perform one task (peg transfer exercise) on a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA), and a similar task on a robotic trainer (Mimic da Vinci Simulator, Intuitive Surgical, Sunnyvale, CA). Participants will then be randomized to practice on the robotic simulator or practice on the laparoscopic trainer for at least 10 repetitions. After the participants complete 10 repetitions, they will be evaluated again on both the laparoscopic and robotic simulator using time to task completion and Mimi DV trainer motion metrics. Two expert laparoscopic and robotic surgeons will also evaluate participant performance using previously validated global rating scales for robotic and laparoscopic surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Medical students with no prior laparoscopic or robotic experience in clinical or practice setting

排除标准

  • Prior laparoscopic or robotic experience in clinical setting or in practice setting

结局指标

主要结局

Global Rating Scale Score on the Laparoscopic Task

时间窗: Study duration

Global rating scale score on the laparoscopic task. A composite score of (1) depth perception, (2) bimanual dexterity, (3) efficiency, (4) tissue handling, (5) time and motion, (6) instrument handling, and (7) flow of operation, each scored 1 through 5 on an anchored Likert scale where higher scores indicated improved proficiency. Point range 7 - 35.

Time to Task Completion (Robotic Task)

时间窗: 1 day of practice

Primary outcome will be time to task completion (seconds) on the robotic task

Global Rating Scale Score on the Robotic Task

时间窗: Study duration

A composite score of (1) depth perception, (2) bimanual dexterity, (3) efficiency, (4) tissue handling, (5) time and motion, (6) instrument handling, and (7) flow of operation, each scored 1 through 5 on an anchored Likert scale where higher scores indicated improved proficiency. Point range 7 - 35.

Time to Task Completion on the Laparoscopic Task

时间窗: 1 day of practice

Time to task completion (seconds) on the laparoscopic task

次要结局

  • Instrument Collisions(study duration)
  • Instrument Out of View(through study completion)
  • Time Spent Using Excessive Force(study duration)
  • Economy of Motion on the Robotic Task(Study duration)
  • Workspace Range(study duration)

研究者

申办方类型
Other
责任方
Sponsor

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