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

Fundación Cardioinfantil Instituto de Cardiología

Status: Not yet enrolling

Conditions: Simulation Training; Vascular Diseases; Competency-Based Education

Treatments: Other: Progression and structured surgical training.

Study type: Interventional

Funder types: Other

Identifiers

NCT06452901

CEIC-013-2024

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Group I

Experimental group

Description:

Will receive the complete structured and progressive training program involving specific micro-surgical skills, VA, and AAOR.

Treatment:

Other: Progression and structured surgical training.

Group II

Active Comparator group

Description:

Will only receive VA and AAOR training.

Treatment:

Other: Progression and structured surgical training.

Group III

Active Comparator group

Description:

Will only receive AAOR training.

Treatment:

Other: Progression and structured surgical training.