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临床试验/NCT02235636
NCT02235636已完成不适用

Da Vinci Robot Compared to Laparoscopic Suturing for Closure of Gastric Incision Among Novice: a Randomized Cross Over Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年7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
20
试验地点
1
主要终点
Task performance

研究概览

简要总结

To compare the performance of surgical suturing using Da Vinci Robotic Surgical System and conventional Laparoscopic surgical suturing among novice

详细描述

Background Da Vinci® Robotic Surgical System (DVRSS) has been widely applied to perform complex minimally invasive surgical procedures across different specialties. This study aimed to investigate the impact of DVRSS on surgical proficiencies among inexperience novice surgeons and compared to conventional laparoscopic surgery.

Methods Twenty medical students (n=20) without surgical experience were enrolled. After a constructive training for basic surgical techniques, participants were randomly allocated into DVR or laparoscopy group. Participants were asked to close five cases (also named five tasks) of a 2cm long incision on pig stomach by using DVR or laparoscopy. Surgical time, successful closure rate and pneumatic bursting pressure of gastric incision withstanding were recorded. In addition, participant performance and workload were quantified by using performance score, scales of Global Rating Scale Assessment (GSA) and NASA-Task Load Index (NASATLI).

研究设计

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

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Medical Students with no prior surgical experience

排除标准

  • Age < 16 or > 60
  • Disability and not able to control the Da Vinci Robot through the console

结局指标

主要结局

Task performance

时间窗: 1 day

The performance of participants for each task would be assessed by objective scoring scale basing on the task completion time, plus well-defined errors during suturing and tying knot.

次要结局

  • Pneumatic bursting pressure for gastric incision(1 day)
  • Rate of success in closure of gastrotomy(1 day)
  • Assessment of participant workload(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Philip Wai Yan Chiu

Professor

Chinese University of Hong Kong

研究点 (1)

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