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临床试验/NCT06301230
NCT06301230已完成不适用

The PLET Study: A Randomized Controlled Trial of Home- Versus Hospital-based Surgical Training

Clarunis - Universitäres Bauchzentrum Basel1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Assessment rating

研究概览

简要总结

The purpose of this study was to assess the effect of training with a personal, portable laparoscopic endo-trainer (PLET) on residents' laparoscopic skills. All participants were randomised to either a home- or hospital-based PLET training group and surgical skill performance was assessed using five laparoscopic exercises. Endpoints consisted ofsubjective and objective assessment ratings as well as exercise time and qualitative data up to 12 weeks. The primary outcome was the difference in exercise time and secondary outcomes included performance scores as well as qualitative data.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •≥ 18 years
  • •surgical resident

排除标准

  • 未提供

研究组 & 干预措施

Hospital-based surgical training group

Active Comparator

This group represents the surgical residents who trained with PLET at the hospital.

干预措施: Portable Laparoscopic Trainer (PLET) (Device)

Home-based surgical training group

Experimental

This group represents the surgical residents who trained with PLET at home.

干预措施: Portable Laparoscopic Trainer (PLET) (Device)

结局指标

主要结局

Assessment rating

时间窗: Baseline, 6 weeks, 12 weeks

Subjective and objective assessment ratings of surgical skills during exercise

Exercise time

时间窗: Baseline, 6 weeks, 12 weeks

Amount of time surgical residents need for laparoscopic exercises

次要结局

  • Qualitative feedback(12 weeks)

研究者

发起方
Clarunis - Universitäres Bauchzentrum Basel
申办方类型
Other
责任方
Sponsor

研究点 (1)

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