Clinical trial NCT06452901: PROgressive struCturEd Simulation-based Surgical Training Program (PROCESS) - Open Vascular Surgery
Official title: PROgressive struCturEd Simulation-based Surgical Training Program (PROCESS) - Open Vascular Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vascular Diseases
Competency-Based Education
Simulation Training
Lead sponsor: Fundación Cardioinfantil Instituto de Cardiología
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.


Eligibility criteria: 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 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.
* Individuals who have had prior exposure to structured simulation programs in vascular surgery will be excluded. Previous familiarity with simulation could influence study outcomes, introducing a prior learning bias that could distort the assessment of the intervention's effectiveness.

Primary outcomes:
measure: Efficacy in the acquisition of technical surgical skills.
timeFrame: 4 months
Secondary outcomes:
measure: The efficacy given by the progression through the different structured modules.
timeFrame: 4 months
measure: The satisfaction of the residents
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References: