LAPARO Analytic vs. Classic Box Trainer on Laparoscopic Skills Training

Официальное название

LAPARO Analytic vs. Classic Box Trainer: A Randomized Trial on Appendicectomy Laparoscopic Skills Training

Обзор

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.

Подробное описание

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.

Intervention Group (n = 30): Will receive a 3-hour in-person training session using the LAPARO Analytic simulator, also supervised by a qualified General Surgery tutor.

Participants with any previous exposure to laparoscopic surgical techniques will be excluded, as well as those who acquire such experience between recruitment and training.

The primary outcome is the quality of technical skill execution and its retention, measured using objective assessment tools. Secondary outcomes include participant satisfaction, captured via structured questionnaires. The study aims to contribute valuable evidence to inform laparoscopic training programs and guide the integration of advanced simulation technologies into surgical education.

Вмешательства

• Другое Laparoscopic Training using the LAPARO Analytic simulator
  Participants in the experimental group will undergo a 3-hour in-person laparoscopic training session using the LAPARO Analytic simulator. The session will be supervised by an experienced General Surgery tutor and will include real-time performance analytics to guide skill acquisition relevant to laparoscopic appendicectomy.
• Другое Laparoscopic Training using a classic Box Trainer
  Participants will receive a single, 3-hour in-person laparoscopic training session using a Classic Box Trainer. Training will be supervised by an experienced General Surgery tutor and focused on key technical skills required for laparoscopic appendicectomy.

Первичные конечные точки

• Technical Performance Score on Laparoscopic Appendicectomy Skills using de GOALS scale [Срок оценки: 15 days after training session]

Вторичные конечные точки (2)

• Procedure Completion Time [Срок оценки: 15 days after training session]
• Self-Perceived Competence in Laparoscopic Skills [Срок оценки: Immediately after cadaver procedure (Day 15)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07081386 · UPorto-LAPTRAIN-NSG

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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