Abstract 3009: Progressive Structured Simulation-based Surgical Training Program (PROCESS) - Open Vascular Surgery: Study Protocol For A Cross-over, Randomized, Double-blinded Clinical Trial.

Abstract

Objective: Vascular surgery has been directed towards endovascular approaches; however, not all patients qualify for these procedures. Open vascular surgery (OVS) remains an alternative, demanding a steep learning curve. Exposure to these procedures has declined resulting in a lack of standardization in acquiring OVS skills. Simulation is a solution to this challenge. However, in OVS, there is scarce evidence for structured programs. The measurement of surgical skills is based on objectively assessable subjective tools; yet, they have limitations as evaluators may introduce inherent individual biases. We aim to compare the effectiveness of technical surgical competencies acquisition between a structured progressive simulation-based training program and isolated experience-based training in OVS. Methods: We will conduct a randomized double-blind crossover clinical trial. A control sequence and an intervention sequence of three subgroups with different exposure levels to the simulation program are proposed using 3D printed models. 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. Double blinding will involve participants and external evaluators. Randomization will occur in block randomization and permuted block randomization. Results: We anticipated that the structured and progressive simulation-based training program objectively enhances technical surgical competencies. We expect to determine a significant difference in the acquisition of technical surgical competencies based on the progression through different modules within the program and validate the reliability of an assessment tool based on objective metrics for technical surgical competencies in OVS. Conclusion: We hope this initiative will impact the formation of future vascular surgeons, complementing experience-based training with simulation-based programs in OVS. Ensuring that the trainee obtains all the necessary tools to perform OVS and standardize an objective assessment evaluation method.