PROgressive Structured Simulation-based Surgical Training Program (PROCESS) - Open Vascular Surgery: Study Protocol for Triple-Arm, Randomized, Simple-Blinded Educational Clinical Trial.

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][1]. ### Competing Interest Statement The authors have declared that no competing interests exist. ### Clinical Trial This study protocol was registered in clinicaltrials.gov with the NCT-ID: [NCT06452901][1]. ### Funding Statement The author(s) received no specific funding for this work. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: N/A I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Due to participants' privacy and Colombian law concerns, the data will not be available for public access but may be available from the corresponding author upon reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT06452901&atom=%2Fmedrxiv%2Fearly%2F2024%2F08%2F22%2F2024.08.22.24312415.atom