PROgressive struCturEd Simulation-based Surgical training program (PROCESS) - Open Vascular Surgery: Study protocol for triple-arm, randomized, simple-blinded educational clinical trial.

Abstract

Introduction: Vascular surgery has been directed towards endovascular approaches; however, not all patients qualify for these procedures. Open vascular surgery remains crucial, demanding a steep learning curve. Exposure to these procedures has declined, resulting in a need for more standardization in acquiring open vascular surgery skills and potentially contributing to poorer outcomes. Simulation offers a solution, yet the evidence for structured programs in open vascular surgery is limited. This study aims to compare the efficacy of technical skill acquisition between a structured, progressive simulation-based training program and traditional experience-based training in open vascular surgery. Methods: A randomized, single-blinded, triple-arm educational clinical trial will be conducted. A control and intervention sequences of three groups with different exposure levels to the simulation program are proposed. Group 1: open abdominal aortic repair, Group 2: vascular anastomosis and open abdominal aortic repair, and Group 3: specific surgical skills, vascular anastomosis, and open abdominal aortic repair. 3D-printed models from AngioCT will be used for the open abdominal aortic repair simulation. Surgical residents of general, vascular, or cardiothoracic surgery programs will be included. Sample size calculation resulted in 45 participants, 15 per group. Simple blinding will involve external evaluators. Randomization will occur as simple randomization. Discussion: We expect that the structured and progressive simulation-based training program would enhance technical surgical skills. Based on the progression through different modules within the program, we aim to determine a significant difference in the acquisition of technical surgical skills. We hypothesize that 3D-printed patient-specific models can enhance participants' vascular surgery training and provide optimal simulated scenarios while prioritizing patient safety. We hope this initiative will impact the formation of future vascular surgeons, shape future training programs, and ensure comprehensive preparation for open vascular surgery. Trial registration: This study protocol was registered in clinicaltrials.gov with the NCT-ID: NCT06452901.