Medical TrainingNCT04997720
Impact of the Microsurgical Technique After a Theoretical-practical Course in Microsurgery
A study testing Training in people with Medical Training and Microsurgery, run by Hospital de Clinicas José de San Martín at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medical Training, Microsurgery, Education
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteArgentina
- Study dates
- 15 Jun 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants who do not complete the entire course will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Medical Training, Microsurgery, Education
- Being tested
- Training
- Keywords
- Academic training, Capacity evaluation, Continuing medical education, Neurosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Each course will consist of:
- Initial evaluation
- Theoretical tutorial
- Training with exercises of increasing complexity.
- Final evaluation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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.
To identify if the year of residence influences the theoretical evaluation of ten multiple-choice questions.
Measured: 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
Measured: 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)
Measured: Change from baseline after 8 hours of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start15 Jun 2021
- Primary completion15 Jun 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas José de San Martín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcos Ezequiel Yasuda, Hospital de Clinicas José de San Martín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997720
- Sponsor's protocol ID
- 1092-21
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANALYSIS OF THE IMPACT ON THE MICRO SURGICAL TECHNIQUE IN RESIDENTS AFTER A THEORETICAL-PRACTICAL COURSE OF MICROSURGERY: A SINGLE GROUP STUDY
- ClinicalTrials.gov ID
- NCT04997720
- Acronym / sponsor ID
- 1092-21
- Conditions
- Medical Training, Microsurgery, Education
- Keywords
- Academic training, Capacity evaluation, Continuing medical education, Neurosurgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hospital de Clinicas José de San MartínUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training | Other | Other: TrainingThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who do not complete the entire course will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingEach course will consist of: 1. Initial evaluation 2. Theoretical tutorial 3. Training with exercises of increasing complexity. 4. Final evaluation. | Other | Training |
Primary outcome
Change of Quality of the execution of the suture
Time frame: 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
Time frame: 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
Time frame: Change from baseline through study completion, an average of 8 hours of training
A theoretical evaluation of ten multiple-choice questions
3 secondary outcomes
The correlation between the year of residence and the changes in the results of the theoretical evaluation of ten multiple-choice questions.
Time frame: 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.
Time frame: 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)
Time frame: Change from baseline after 8 hours of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Medical Training
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Not yet recruitingObservational study
Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
Not yet recruiting
Title of Study: Anesthesiologists' Learning Curves for Ultrasound Assessment of Difficult Airway
Airway Ultrasound, Difficult Airway Management
Not yet recruiting
Generative AI-Assisted Personalized Feedback for Laparoscopic Skill Learning in Medical Undergraduates
Medical Education
Not yet recruiting
Simulation-Based Medical Waste Training for Palliative Caregivers
Medical Waste Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Medical Training and Microsurgery, run by Hospital de Clinicas José de San Martín at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Quality of the execution of the suture (time frame: Change from baseline of Score Stanford Microsurgery and Resident Training Scale (SMART)through study completion, an average of 8 hours of training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.