ClinicalTrials.gg
RecruitingNCT05436899Updated Aug 22, 2023

A Pilot Study on Training Simulator Efficacy

An interventional study of LapSim training and LapSim exam in Laparoscopic Surgery, Medical Education and Simulation Training, sponsored by Università degli Studi dell'Insubria. Recruiting at 1 site in Italy. Open to participants aged 24 Years and older. Per ClinicalTrials.gov, last updated 2023-08-22.

Sponsored by Università degli Studi dell'Insubria · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 2 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
24 Years and older
Sex
All
01

Study summary

The purpose of this study is to plan an effective learning path in minimally invasive thoracic and general surgery with a virtual training simulator for trainees and to assess the improvement of residents' surgical skills by the introduction of this virtual training program.

Read the detailed description

All thoracic and general surgery trainees at the first and second year of residency will be randomized in two groups: A) trainees undergoing an intensive (twice a week) virtual training program and B) those undergoing a non-intensive virtual training program (once a week).

The virtual training program will be organized in 4 modules, each of 12 weeks and, according to the training simulator instructions, for each surgical skill there are predetermined goals to be achieved by the trainee. Data about duration of surgical maneuvers and type and number of mistakes made by the trainee at each training session will be collected and compared with those of the same trainee at the previous session; this will assess the number of training sessions required to achieve the training simulator predetermined goals. Moreover, the same data will be registered at the beginning and at the end of each courses to compare the two groups of trainees (intensive vs non-intensive program).

02

Conditions studied

  • Laparoscopic Surgery
  • Medical Education
  • Simulation Training

Keywords

  • Education
  • Simulation
  • Virtual reality
  • Laparoscopic surgery
  • Learning curve
  • Endoscopic surgery
  • Thoracoscopic surgery
03

In context

Lead sponsor

Università degli Studi dell'Insubria is the lead sponsor of 68 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Trainees at the first and second year of residency in thoracic or general surgery

Exclusion criteria

Exclusion Criteria:

  • Fully trained surgeons
  • Persons who are not trainees at year of specialization higher than the second
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Intensive training group

    Participants in this group will undergo an intensive virtual training program twice a week

    Other: LapSim training · Other: LapSim exam

  • Active comparator
    Non-Intensive training group

    Participants in this group will undergo a non-intensive virtual training program once a week

    Other: LapSim training · Other: LapSim exam

Interventions

  • OtherLapSim training

    Complete 4 courses, each of 12 weeks, of virtual reality simulation on LapSim surgical simulator.

  • OtherLapSim exam

    Completed at the beginning and at the end of each of the 4 courses the corresponding exam task.

06

What researchers measure

Primary outcomes

  1. Learning curves of time, errors and economy of motion for each training tasks

    For each task, the computer automatically measures set parameters. Time, errors and economy of motion will be used in data analysis to create the learning curves for both intensive and non-intensive training group.

    Time frame: 48 weeks

Secondary outcomes

  1. Intensive vs non-intensive training group

    For each exam tasks of the four training courses, compare the difference between the intensive and non-intensive training group, before and after each program training. Time, errors and economy of motion will be used in data analysis.

    Time frame: 48 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Data that underlie the results reported in this article (text, tables, figures, and appendices)

Supporting information: Study protocol

Time frame: Immediately following publication. No end date.

Access criteria: Proposals should be directed to andrea.imperatori@uninsubria.it

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2022 to primary completion in Dec 2022, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2022
First posted
Jun 29, 2022
StartActual
Sep 1, 2022
Primary completionActual
Dec 1, 2022
CompletionEst.
Dec 31, 2025
Last update
Aug 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05436899
Lead sponsor
Università degli Studi dell'Insubria
Responsible party
Andrea Selenito Imperatori (Associate Professor of Thoracic Surgery, Università degli Studi dell'Insubria) — Principal investigator
First posted
Jun 29, 2022
Start date
Sep 1, 2022
Primary completion
Dec 1, 2022
Completion
Dec 31, 2025 (estimated)
Last update
Aug 22, 2023

Study contacts

Andrea Imperatori
Contact
andrea.imperatori@uninsubria.it
+39-0332-393195
Andrea Imperatori
principal investigator · Università degli Studi dell'Insubria

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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