LAPARO Analytic vs. Classic Box Trainer on Laparoscopic Skills Training

Not Applicable

Not yet recruiting

• Conditions: Laparoscopic Surgical Training

• Registration Number: NCT07081386
• Lead Sponsor: Universidade do Porto

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-15
• Study First Submitted QC: 2025-07-15
• Study First Posted: 2025-07-23
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-30
• Study Start: 2025-08-01
• Primary Completion: 2025-11
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Technical Performance Score on Laparoscopic Appendicectomy Skills using de GOALS scale	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.

Secondary Outcome Measures

Name	Time	Method
Procedure Completion Time	15 days after training session	The duration of the laparoscopic appendicectomy performed on the cadaver model will be measured in minutes and seconds. The total time required to complete the surgical task will be compared between groups to assess efficiency.
Self-Perceived Competence in Laparoscopic Skills	Immediately after cadaver procedure (Day 15)	Participants will complete a post-training Likert-scale questionnaire assessing their self-perceived competence in performing key laparoscopic tasks: identifying the appendix, lysis of adhesions, vascular control, stump division, and safe extraction. Responses range from 1 (strongly disagree) to 5 (strongly agree).