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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Education; Microsurgery; Medical Training
• Intervention / Treatment: Other: Training

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autónoma De Buenos Aires
    • Caba, Ciudad Autónoma De Buenos Aires, Argentina, 1120
      • Ezequiel Yasuda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: Training; Each course will consist of: Initial evaluation; Theoretical tutorial; Training with exercises of increasing complexity.; Final evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas José de San Martín

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Anticipated): June 15, 2022
• Study Completion (Anticipated): December 15, 2022

Study Registration Dates

• First Submitted: July 3, 2021
• First Submitted That Met QC Criteria: July 31, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: July 31, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Neurosurgery; Continuing medical education; Academic training; Capacity evaluation
• Other Study ID Numbers: 1092-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No