Laparoscopic SurgeryNCT05436899
A Pilot Study on Training Simulator Efficacy
A study testing LapSim training and LapSim exam in people with Laparoscopic Surgery and Medical Education, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 24 years and older
- Conditions the study is for
- Laparoscopic Surgery, Medical Education, Simulation Training
- What is being tested?
- LapSim training and LapSim exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 24 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trainees at the first and second year of residency in thoracic or general surgery
Who cannot join
- Fully trained surgeons
- Persons who are not trainees at year of specialization higher than the second
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Università degli Studi dell'Insubria
Varese, 21100
Andrea S Imperatori, +39-0332-393195, andrea.imperatori@uninsubria.it
About this study
Official title: Training Simulator Efficacy in Developing Thoracic and General Surgical Skills in an Academic Residency Program: a Pilot Study
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).
- Conditions
- Laparoscopic Surgery, Medical Education, Simulation Training
- Being tested
- LapSim training, LapSim exam
- Keywords
- Education, Simulation, Virtual reality, Laparoscopic surgery, Learning curve, Endoscopic surgery, Thoracoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapSim trainingOther
Complete 4 courses, each of 12 weeks, of virtual reality simulation on LapSim surgical simulator.
LapSim examOther
Completed at the beginning and at the end of each of the 4 courses the corresponding exam task.
| Study group | Role | What they receive |
|---|---|---|
| Intensive training group | Experimental | Participants in this group will undergo an intensive virtual training program twice a week Receives: Other: LapSim training; Other: LapSim exam |
| Non-Intensive training group | Active comparator | Participants in this group will undergo a non-intensive virtual training program once a week Receives: Other: LapSim training; Other: LapSim exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Sep 2022
- Primary completion1 Dec 2022
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies 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
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Selenito Imperatori, Università degli Studi dell'Insubria
- Investigators
- Andrea Imperatori, Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436899
- Sponsor's protocol ID
- LapSim training program
- Status last verified
- Aug 2023
- First submitted
- 24 Jun 2022
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that underlie the results reported in this article (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Simulator Efficacy in Developing Thoracic and General Surgical Skills in an Academic Residency Program: a Pilot Study
- ClinicalTrials.gov ID
- NCT05436899
- Acronym / sponsor ID
- LapSim training program
- Conditions
- Laparoscopic Surgery, Medical Education, Simulation Training
- Keywords
- Education, Simulation, Virtual reality, Laparoscopic surgery, Learning curve, Endoscopic surgery, Thoracoscopic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Jun 2022 (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.
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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive training group | Experimental | Other: LapSim training, Other: LapSim examParticipants in this group will undergo an intensive virtual training program twice a week |
| Non-Intensive training group | Active comparator | Other: LapSim training, Other: LapSim examParticipants in this group will undergo a non-intensive virtual training program once a week |
Who may qualify
- Ages
- 24 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Trainees at the first and second year of residency in thoracic or general surgery
Key exclusion criteria (2 listed)
- Fully trained surgeons
- Persons who are not trainees at year of specialization higher than the second
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 |
|---|---|---|
| LapSim trainingComplete 4 courses, each of 12 weeks, of virtual reality simulation on LapSim surgical simulator. | Other | Intensive training group, Non-Intensive training group |
| LapSim examCompleted at the beginning and at the end of each of the 4 courses the corresponding exam task. | Other | Intensive training group, Non-Intensive training group |
Primary outcome
Learning curves of time, errors and economy of motion for each training tasks
Time frame: 48 weeks
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.
1 secondary outcome
Intensive vs non-intensive training group
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: Yes. Data that underlie the results reported in this article (text, tables, figures, and appendices)
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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. This study is not recruiting at the moment.
Andrea Imperatori principal investigator
Università degli Studi dell'Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LapSim training and LapSim exam in people with Laparoscopic Surgery and Medical Education, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Imperatori (+39-0332-393195, andrea.imperatori@uninsubria.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning curves of time, errors and economy of motion for each training tasks (time frame: 48 weeks). 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 22 Aug 2023.