LAPARO Analytic vs. Classic Box Trainer: A Randomized Trial on Appendicectomy Laparoscopic Skills Training
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Technical Performance Score on Laparoscopic Appendicectomy Skills using de GOALS scale
研究概览
简要总结
This randomized controlled trial investigates the effectiveness of two laparoscopic training modalities - Classic Box Trainers and the LAPARO Analytic - in teaching fundamental surgical skills for laparoscopic appendicectomy. A total of 60 first-year medical residents (interns) from Centro Hospitalar Universitário de São João (CHUSJ) will be recruited and randomly assigned to one of two training groups. One group will undergo a 3-hour in-person training session using Classic Box Trainers, while the other group will train using the LAPARO Analytic simulator, both under the supervision of experienced General Surgery tutors. The study aims to evaluate technical skill acquisition, retention, and participant satisfaction. Outcomes will be assessed through objective performance metrics and participant feedback, contributing to the optimization of laparoscopic education methods.
详细描述
Minimally invasive techniques have become the standard of care in elective abdominal surgery, leading to a significant increase in laparoscopic procedures. This shift presents a major training challenge, as the acquisition of core laparoscopic skills - such as hand-eye coordination via video and depth perception - requires a steep and lengthy learning curve that may be unsafe and inefficient if conducted exclusively in the operating room.
To address these limitations, simulation-based training has emerged as an effective alternative. Classic Box Trainers are widely used in surgical education, allowing for repeated, structured practice in a safe, non-clinical environment. However, recent advancements have introduced modern systems like the LAPARO Analytic, which provides real-time instrument tracking, objective scoring, and performance analytics.
Despite their growing use, there is a lack of direct comparative evidence on the training efficacy of these two modalities, particularly for initial surgical procedures such as laparoscopic appendicectomy. This randomized prospective trial aims to fill this gap by evaluating the relative effectiveness of the LAPARO Analytic versus Classic Box Trainers in the acquisition and retention of essential laparoscopic skills.
A total of 60 first-year medical residents (interns) at Centro Hospitalar Universitário de São João (CHUSJ) will be recruited via convenience sampling and voluntary sign-up. Participants will be randomly assigned using an online tool (Research Randomizer) into two groups:
Control Group (n = 30): Will receive a 3-hour in-person training session using Classic Box Trainers, supervised by an experienced General Surgery tutor.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •First-year medical residents (internos de ano comum) currently enrolled at Centro Hospitalar Universitário de São João (CHUSJ).
- •Voluntary participation confirmed by completion of an informed consent and online registration form.
- •Availability to participate in both the initial training session and the follow-up cadaveric assessment 15 days later.
排除标准
- •Any prior exposure to laparoscopic surgical techniques formal training.
- •Engagement in any laparoscopic training activities between the recruitment date and the practical evaluation session.
- •Inability to attend either the scheduled training or the cadaveric assessment session.
结局指标
主要结局
Technical Performance Score on Laparoscopic Appendicectomy Skills using de GOALS scale
时间窗: 15 days after training session
Participants' technical skills will be assessed 15 days after training during a laparoscopic appendicectomy performed on a human cadaver. Procedures will be video-recorded and evaluated by blinded expert raters using the Global Operative Assessment of Laparoscopic Skills (GOALS) scale. Domains assessed include depth perception, bimanual dexterity, efficiency, tissue handling, and autonomy. Scores will be compared between the two groups.
次要结局
- Procedure Completion Time(15 days after training session)
- Self-Perceived Competence in Laparoscopic Skills(Immediately after cadaver procedure (Day 15))
