Skills AcquisitionDPiLSNCT05834504
Exploring the Intervals in Distributed Laparoscopic Skills Training
A study testing Short distributed training (1-2 days) in people with Skills Acquisition and Simulation, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.
Trial summary
The objective of this trial is to investigate if short intervals (1-2 days) between training sessions are more efficient than practicing with longer intervals (6-8 days) between sessions during proficiency-based laparoscopic simulator training. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skills Acquisition, Simulation, Laparoscopy
- What is being tested?
- Short distributed training (1-2 days)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Aug 2022to 26 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Master's degree medical students, enrolled at a Danish University.
Who cannot join
- Medical students that have participated in prior studies or similar involving laparoscopic training.
- Performing laparoscopy surgery between the intervention and the retention test 3-5 weeks after.
- No informed consent.
- Does not speak Danish on a conversational level.
- Any disability or injury regarding eyesight and mobility.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Academy For Medical Education and Simulation (Cames)
Copenhagen, Capital Region, 2100
About this study
The objective of this trial is to investigate if short intervals (1-2 days) between training sessions are more efficient than practicing with longer intervals (6-8 days) between sessions during proficiency-based laparoscopic simulator training. Our hypothesis is that just 1-2 days of break between sessions is optimal for the acquisition of laparoscopic skills and that a shorter interval between sessions is optimal for training.
- Conditions
- Skills Acquisition, Simulation, Laparoscopy
- Being tested
- Short distributed training (1-2 days)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short distributed training (1-2 days)Other
The intervention group will practice four basic skills and one procedural module on the Laparoscopic "Lapsim" Virtual Reality Simulator. They will practice with 1-2 days of break in between training sessions until proficiency level is achieved.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will practice four basic skills and one procedural module on the Laparoscopic "Lapsim" Virtual Reality Simulator. They will practice with 6-8 days of break in between training sessions until proficiency level is achieved. |
| Intervention Group | Experimental | The intervention group will practice four basic skills and one procedural module on the Laparoscopic "Lapsim" Virtual Reality Simulator. They will practice with 1-2 days of break in between training sessions until proficiency level is achieved. Receives: Other: Short distributed training (1-2 days) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to proficiency
The total effective training time (minutes) to reach the predefined proficiency level for both the four basic skills and the salpingectomy module.
Measured: 6 months
Secondary outcomes (1)
Retention test
The total effective training time (minutes) to reach the predefined proficiency level for both the four basic skills and the salpingectomy module after 3-5 weeks without laparoscopic training from the last training session.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start29 Aug 2022
- Primary completion26 Mar 2023
- Study completion26 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skills AcquisitionStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen Academy for Medical Education and Simulation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai-Yen Tang, Copenhagen Academy for Medical Education and Simulation
- Investigators
- Flemming Bjerrum, MD, Study director, Copenhagen Academy for Medical Education and Simulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834504
- Sponsor's protocol ID
- DPiLS trial
- Acronym
- DPiLS
- Status last verified
- Apr 2023
- First submitted
- 22 Aug 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Intervals in Distributed Laparoscopic Skills Training
- ClinicalTrials.gov ID
- NCT05834504
- Acronym / sponsor ID
- DPiLS / DPiLS trial
- Conditions
- Skills Acquisition, Simulation, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 26 Mar 2023 (actual)
- Study completion
- 26 Mar 2023 (actual)
- First posted
- 28 Apr 2023 (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 objective of this trial is to investigate if short intervals (1-2 days) between training sessions are more efficient than practicing with longer intervals (6-8 days) between sessions during proficiency-based laparoscopic simulator training. Our hypothesis is that just 1-2 days of break between sessions is optimal for the acquisition of laparoscopic skills and that a shorter interval between sessions is optimal for training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will practice four basic skills and one procedural module on the Laparoscopic "Lapsim" Virtual Reality Simulator. They will practice with 6-8 days of break in between training sessions until proficiency level is achieved. |
| Intervention Group | Experimental | Other: Short distributed training (1-2 days)The intervention group will practice four basic skills and one procedural module on the Laparoscopic "Lapsim" Virtual Reality Simulator. They will practice with 1-2 days of break in between training sessions until proficiency level is achieved. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Master's degree medical students, enrolled at a Danish University.
Key exclusion criteria (5 listed)
- Medical students that have participated in prior studies or similar involving laparoscopic training.
- Performing laparoscopy surgery between the intervention and the retention test 3-5 weeks after.
- No informed consent.
- Does not speak Danish on a conversational level.
- Any disability or injury regarding eyesight and mobility.
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 |
|---|---|---|
| Short distributed training (1-2 days)The intervention group will practice four basic skills and one procedural module on the Laparoscopic "Lapsim" Virtual Reality Simulator. They will practice with 1-2 days of break in between training sessions until proficiency level is achieved. | Other | Intervention Group |
Primary outcome
Time to proficiency
Time frame: 6 months
The total effective training time (minutes) to reach the predefined proficiency level for both the four basic skills and the salpingectomy module.
1 secondary outcome
Retention test
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Flemming Bjerrum, MD study director
Copenhagen Academy for Medical Education and Simulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short distributed training (1-2 days) in people with Skills Acquisition and Simulation, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.
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 5 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: finished, as of the sponsor's last update on 28 Apr 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to proficiency (time frame: 6 months). 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 28 Apr 2023.