跳至主要内容
临床试验/NCT04997720
NCT04997720Unknown不适用

ANALYSIS OF THE IMPACT ON THE MICRO SURGICAL TECHNIQUE IN RESIDENTS AFTER A THEORETICAL-PRACTICAL COURSE OF MICROSURGERY: A SINGLE GROUP STUDY

Hospital de Clinicas José de San Martín1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
45
试验地点
1
主要终点
Change of Quality of the execution of the suture

研究概览

简要总结

A single group study will be carried out in the Microsurgery Laboratory, Neurosurgery Department, Hospital de Clínicas, and the Center for Microsurgical Skills of the Argentine Association of Neurosurgery. The objective of the study is to evaluate the effect of theoretical-practical course learning in neurosurgery and plastic surgery residents.

详细描述

Introduction

In the second half of the 20th century, the use of the surgical microscope became popular in neurosurgery. In the last twenty years, simulation has gained worldwide acceptance as a teaching tool in medicine, especially microsurgery. For this, various training models have been created.

Objective

To evaluate the effect of the theoretical-practical course learning in neurosurgery and plastic surgery residents.

Materials and methods

A single group study will be carried out in the Microsurgery Laboratory, Neurosurgery Department, Hospital de Clínicas, and the Center for Microsurgical Skills of the Argentine Association of Neurosurgery. Medical doctors of both genders will be included in the first three years of neurosurgical or plastic surgery training from any center in Argentina. The course will be theoretical-practical, lasting eight hours, divided into two meetings with a theoretical class and practical microsurgery exercises. It will be supervised by teachers microsurgery experienced. An Initial and final evaluation will be carried out and the scores obtained between both theoretical and practical evaluations will be compared. In the practical evaluations, the time and the SMART scale will be analyzed. Categorical variables will be reported as absolute and relative numbers. The normality of the data will be verified by the Kolmogorov-Smirnov test. Continuous variables will be reported as mean and standard deviations or median and interquartile ranges. Student's t test, Mann-Whitney U test will be used to compare means, when appropriate, according to the distribution of variables. The categorical variables will be compared with the χ2 test.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

The evaluation will be in charge of the teacher who will record the practical evaluation. Then all the videos will be analyzed blindly by a neurosurgeon with experience in microsurgery. Statistical analyzes will also be analyzed blindly.

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Doctors in the first three years of neurosurgical training or plastic surgery in any center in Argentina.
  • •Both gender will be included without age limit.

排除标准

  • •Participants who do not complete the entire course will be excluded

研究组 & 干预措施

Training

Other

The course will be theoretical-practical, lasting eight hours, divided into two meetings with a theoretical class and practical exercises in microsurgery of increasing complexity. The course will also have an initial and final evaluation.

干预措施: Training (Other)

结局指标

主要结局

Change of Quality of the execution of the suture

时间窗: Change from baseline of Score Stanford Microsurgery and Resident Training Scale (SMART)through study completion, an average of 8 hours of training

The process of executing the suture will be evaluated using the Stanford Microsurgery and Resident Training Scale (SMART) (9 to 45, higher scores mean a better outcome)

Change of Time of the execution of the suture

时间窗: Change from baseline through study completion, an average of 8 hours of training

The time in seconds required to complete the evaluation

Change of Theoretical knowledge

时间窗: Change from baseline through study completion, an average of 8 hours of training

A theoretical evaluation of ten multiple-choice questions

次要结局

  • The correlation between the year of residence and the changes in the results of the theoretical evaluation of ten multiple-choice questions.(Change from baseline after 8 hours of training)
  • The correlation between the year of residence and the changes in the results of the time in seconds required to complete the evaluation.(Change from baseline after 8 hours of training)
  • The correlation between the year of residence and the changes in the process of executing the suture will be evaluated using the Stanford Microsurgery and Resident Training Scale (SMART) (9 to 45, higher scores mean a better outcome)(Change from baseline after 8 hours of training)

研究者

发起方
Hospital de Clinicas José de San Martín
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcos Ezequiel Yasuda

Medical Doctor

Hospital de Clinicas José de San Martín

研究点 (1)

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