PROgressive struCturEd Simulation-based Surgical Training Program (PROCESS) - Open Vascular Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación Cardioinfantil Instituto de Cardiología

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Vascular Surgery, Cardiothoracic Surgery, and General Surgery residents.

Over 18 years old.

Disqualifiers

Serious illnesses, such as advanced cancer, decompensated cardiovascular diseases, or severe neurological disorders, could be exclusion criteria due to concerns about the participant's safety and ability to complete the study.

Participants who have known allergies to components of the interventions or have experienced severe adverse reactions in the past will be excluded from the study.

Any medical condition that could interfere with the participant's ability to complete assessments or follow study guidelines could be a reason for exclusion. This could include, for example, severe physical disabilities or illnesses requiring continuous hospitalization.

Individuals who cannot provide valid informed consent due to cognitive issues, mental impairment, or legal incapacity will be excluded from the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Progression and structured surgical training.

    Other intervention

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Group IExperimental treatment 1 intervention
Group B: Group IIActive comparator 1 intervention
Group C: Group IIIActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy in the acquisition of technical surgical skills.

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.

Time frame
4 months

Secondary outcomes

1

The efficacy given by the progression through the different structured modules.

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.

Time frame
4 months
2

The satisfaction of the residents

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.

Time frame
4 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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