LAPARO Analytic vs. Classic Box Trainer on Laparoscopic Skills Training

NCT ID: NCT07081386

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2025-12-31

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.

Conditions

Laparoscopic Surgical Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Classic Box Trainer Group

Participants in this group 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.

Group Type: OTHER

Laparoscopic Training using a classic Box Trainer

Intervention Type: OTHER

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.

LAPARO Analytic Group

Participants in this 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.

Group Type: EXPERIMENTAL

Laparoscopic Training using the LAPARO Analytic simulator

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

UPorto-LAPTRAIN-NSG

Identifier Type: -

Identifier Source: org_study_id