Competency-Based Education, Simulation Training, Vascular Diseases
Conditions
Brief summary
A triple-arm, randomized, simple-blinded clinical trial will be conducted. A control sequence and an intervention sequence of three subgroups with different exposure levels to the simulation program are proposed. Group 1: open abdominal aortic repair (AAOR), Group 2: vascular anastomosis (VA) and AAOR, and Group 3: specific micro-surgical skills, VA and AAOR. Surgical residents of general, vascular, or cardiovascular surgery programs will be included. Sample size calculation resulted in 45 participants, 15 in each group. Simple blinding will involve external evaluators. Randomization will occur as a simple randomization.
Interventions
OTHERProgression and structured surgical training.
Participants will be exposed to different amounts of open vascular surgical training, but only group I will receive the complete structured and progressive training program. This ensures that all participants have access to the potential benefits derived from the intervention. Current evidence supports this approach, which supports the benefits of medical simulation in the training process of surgical residents.
Sponsors
Fundación Cardioinfantil Instituto de Cardiología
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Evaluators, who are external to the researchers, will be single-blinded to assess the effectiveness of different interventions. They will remain unaware of the participants' group assignments. Privacy will be maintained through coding and presenting de-identified data. Data will also be presented without voices, glove usage, and image distortion to prevent identification of personal details such as gender, race, or other characteristics.
Intervention model description
A triple-arm, randomized, simple-blinded clinical trial will be conducted. A control sequence and an intervention sequence of three subgroups with different exposure levels to the simulation program are proposed. Group 1: open abdominal aortic repair (AAOR), Group 2: vascular anastomosis (VA) and AAOR, and Group 3: specific micro-surgical skills, VA and AAOR
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Vascular Surgery, Cardiothoracic Surgery, and General Surgery residents. * Over 18 years old.
Exclusion criteria
* Serious illnesses, such as advanced cancer, decompensated cardiovascular diseases, or severe neurological disorders, could be
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy in the acquisition of technical surgical skills. | 4 months | Pre- and post-intervention individual measures will be taken using the OPEn Aortic Aneurysm Repair Assessment of Technical Expertise (OPERATE) tool to compare the efficacy of the simulated program. The unit of measure are the points of OPERATE Scale with a established passing score of 27.7. A higher score means a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy given by the progression through the different structured modules. | 4 months | The results of the 3 arms will be compared. The unit of measure are the points of OPERATE Scale with a established passing score of 27.7. A higher score means a better outcome. |
| The satisfaction of the residents | 4 months | Surveys guided by a Likert Scale will measure the Level 1 of Kirkpatricks levels based on the reaction and satisfaction of the participants after the implementation of the interventions. The unit of measure will be the result on the Likert scale; the minimum score is 1, and the maximum is 10. A higher score means a better outcome. |
Contacts
Primary ContactCamilo A Velandia-Sánchez, MD
Backup ContactJuan G Barrera-Carvajal, MD
Outcome results
None listed