Laparoscopic Surgical TrainingNCT07081386
LAPARO Analytic vs. Classic Box Trainer on Laparoscopic Skills Training
A study testing Laparoscopic Training using the LAPARO Analytic simulator and Laparoscopic Training using a classic Box Trainer in people with Laparoscopic Surgical Training, run by Universidade do Porto.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Surgical Training
- What is being tested?
- Laparoscopic Training using the LAPARO Analytic simulator and Laparoscopic Training using a classic Box Trainer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: LAPARO Analytic vs. Classic Box Trainer: A Randomized Trial on Appendicectomy Laparoscopic Skills Training
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.
Read the 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
- Being tested
- Laparoscopic Training using the LAPARO Analytic simulator, Laparoscopic Training using a classic Box Trainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Training using the LAPARO Analytic simulatorOther
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.
Laparoscopic Training using a classic Box TrainerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Classic Box Trainer Group | Other | 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. Receives: Other: Laparoscopic Training using a classic Box Trainer |
| LAPARO Analytic Group | Experimental | 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. Receives: Other: Laparoscopic Training using the LAPARO Analytic simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Performance Score on Laparoscopic Appendicectomy Skills using de GOALS scale
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.
Measured: 15 days after training session
Secondary outcomes (2)
Procedure Completion Time
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.
Measured: 15 days after training session
Self-Perceived Competence in Laparoscopic Skills
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).
Measured: Immediately after cadaver procedure (Day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Surgical TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081386
- Sponsor's protocol ID
- UPorto-LAPTRAIN-NSG
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LAPARO Analytic vs. Classic Box Trainer: A Randomized Trial on Appendicectomy Laparoscopic Skills Training
- ClinicalTrials.gov ID
- NCT07081386
- Acronym / sponsor ID
- UPorto-LAPTRAIN-NSG
- Conditions
- Laparoscopic Surgical Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic Box Trainer Group | Other | Other: Laparoscopic Training using a classic Box TrainerParticipants 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. |
| LAPARO Analytic Group | Experimental | Other: Laparoscopic Training using the LAPARO Analytic simulatorParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Training using the LAPARO Analytic simulatorParticipants 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. | Other | LAPARO Analytic Group |
| Laparoscopic Training using a classic Box TrainerParticipants 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. | Other | Classic Box Trainer Group |
Primary outcome
Technical Performance Score on Laparoscopic Appendicectomy Skills using de GOALS scale
Time frame: 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.
2 secondary outcomes
Procedure Completion Time
Time frame: 15 days after training session
Self-Perceived Competence in Laparoscopic Skills
Time frame: Immediately after cadaver procedure (Day 15)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Training using the LAPARO Analytic simulator and Laparoscopic Training using a classic Box Trainer in people with Laparoscopic Surgical Training, run by Universidade do Porto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Performance Score on Laparoscopic Appendicectomy Skills using de GOALS scale (time frame: 15 days after training session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.