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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04997720
Other study ID # 1092-21
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 15, 2021
Est. completion date December 15, 2022

Study information

Verified date July 2021
Source Hospital de Clinicas José de San Martín
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 45
Est. completion date December 15, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Participants who do not complete the entire course will be excluded

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Training
Each course will consist of: Initial evaluation Theoretical tutorial Training with exercises of increasing complexity. Final evaluation.

Locations

Country Name City State
Argentina Ezequiel Yasuda Caba Ciudad Autónoma De Buenos Aires

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas José de San Martín

Country where clinical trial is conducted

Argentina, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Quality of the execution of the suture 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 of Score Stanford Microsurgery and Resident Training Scale (SMART)through study completion, an average of 8 hours of training
Primary Change of Time of the execution of the suture The time in seconds required to complete the evaluation Change from baseline through study completion, an average of 8 hours of training
Primary Change of Theoretical knowledge A theoretical evaluation of ten multiple-choice questions Change from baseline through study completion, an average of 8 hours of training
Secondary The correlation between the year of residence and the changes in the results of the theoretical evaluation of ten multiple-choice questions. To identify if the year of residence influences the theoretical evaluation of ten multiple-choice questions. Change from baseline after 8 hours of training
Secondary The correlation between the year of residence and the changes in the results of the time in seconds required to complete the evaluation. To identify if the year of residence influences the time in seconds required to complete the evaluation Change from baseline after 8 hours of training
Secondary 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) To identify if the year of residence influences 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
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