Impact of the Microsurgical Technique After a Theoretical-practical Course in Microsurgery

Not Applicable

• Conditions: Microsurgery; Medical Training; Education
• Interventions: Other: Training

• Registration Number: NCT04997720
• Lead Sponsor: Hospital de Clinicas José de San Martín

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-06-15
• Status Verified: 2021-07
• Study First Submitted: 2021-07-03
• Study First Submitted QC: 2021-07-31
• Last Update Submitted: 2021-07-31
• Study First Posted: 2021-08-10
• Last Update Posted: 2021-08-10
• Primary Completion: 2022-06-15
• Study Completion: 2022-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Training	Training	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.

Primary Outcome Measures

Name	Time	Method
Change of Quality of the execution of the suture	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	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	Change from baseline through study completion, an average of 8 hours of training	A theoretical evaluation of ten multiple-choice questions

Secondary Outcome Measures

Name	Time	Method
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	To identify if the year of residence influences the theoretical evaluation of ten multiple-choice questions.
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	To identify if the year of residence influences the time in seconds required to complete the evaluation
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	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)

Trial Locations

Locations (1)

Ezequiel Yasuda; 🇦🇷 Caba, Ciudad Autónoma De Buenos Aires, Argentina