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

Education Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04997720
• Other study ID #: 1092-21
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Education
• Medical Training
• Microsurgery

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