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

Sponsor
Hospital de Clinicas José de San Martín (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04997720
Collaborator
(none)
45
1
1
18
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Training
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
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.
Primary Purpose:
Other
Official Title:
ANALYSIS OF THE IMPACT ON THE MICRO SURGICAL TECHNIQUE IN RESIDENTS AFTER A THEORETICAL-PRACTICAL COURSE OF MICROSURGERY: A SINGLE GROUP STUDY
Actual Study Start Date :
Jun 15, 2021
Anticipated Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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

  3. 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

  1. 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.

  2. 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

  3. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ezequiel Yasuda Caba Ciudad Autónoma De Buenos Aires Argentina 1120

Sponsors and Collaborators

  • Hospital de Clinicas José de San Martín

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marcos Ezequiel Yasuda, Medical Doctor, Hospital de Clinicas José de San Martín
ClinicalTrials.gov Identifier:
NCT04997720
Other Study ID Numbers:
  • 1092-21
First Posted:
Aug 10, 2021
Last Update Posted:
Aug 10, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marcos Ezequiel Yasuda, Medical Doctor, Hospital de Clinicas José de San Martín

Study Results

No Results Posted as of Aug 10, 2021