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

NCT04997720 | Unknown

• 1 other identifier: 1092-21
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Medical Training; Microsurgery; Education

Keywords

Academic training; Capacity evaluation; Continuing medical education; Neurosurgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Training

OTHER

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

Interventions

Training OTHER

Each course will consist of: 1. Initial evaluation 2. Theoretical tutorial 3. Training with exercises of increasing complexity. 4. Final evaluation.

Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants who do not complete the entire course will be excluded

Sponsors & Collaborators

• Hospital de Clinicas José de San Martín: lead

Study Sites (1)

Ezequiel Yasuda

Caba, Buenos Aires F.D., 1120, Argentina

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 3, 2021
• First Posted: August 10, 2021
• Study Start: June 15, 2021
• Primary Completion: June 15, 2022
• Study Completion: December 15, 2022
• Last Updated: August 10, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)