PROgressive struCturEd Simulation-based Surgical Training Program (PROCESS) - Open Vascular Surgery
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Fundación Cardioinfantil Instituto de Cardiología
- 入组人数
- 45
- 主要终点
- Efficacy in the acquisition of technical surgical skills.
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Evaluators, who are external to the researchers, will be single-blinded to assess the effectiveness of different interventions. They will remain unaware of the participants' group assignments. Privacy will be maintained through coding and presenting de-identified data. Data will also be presented without voices, glove usage, and image distortion to prevent identification of personal details such as gender, race, or other characteristics.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Vascular Surgery, Cardiothoracic Surgery, and General Surgery residents.
- •Over 18 years old.
排除标准
- •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.
结局指标
主要结局
Efficacy in the acquisition of technical surgical skills.
时间窗: 4 months
Pre- and post-intervention individual measures will be taken using the OPEn Aortic Aneurysm Repair Assessment of Technical Expertise (OPERATE) tool to compare the efficacy of the simulated program. The unit of measure are the points of OPERATE Scale with a established passing score of 27.7. A higher score means a better outcome.
次要结局
- The satisfaction of the residents(4 months)
- The efficacy given by the progression through the different structured modules.(4 months)
研究者
Camilo Alejandro Velandia Sánchez
Mandatory Social Service Medical Doctor
Fundación Cardioinfantil Instituto de Cardiología