Depth PerceptionLVGNCT02407483
Laparoscopic Training With Laser Guidance Trial
A study testing Laser Visual Guidance and 2 D vision in people with Depth Perception, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
"Laparoscopic simulation training with or without laser visual guidance -A randomised study" which investigates if the use of laser visual guidance can help the novices to learn the laparoscopic skills. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Depth Perception
- What is being tested?
- Laser Visual Guidance and 2 D vision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Aug 2015
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Surgical novices / medical students enrolled at The Faculty of Health Science, University of Copenhagen.
- Participants are required to provide informed consent before inclusion.
Who cannot join
- Participation in prior studies involving laparoscopic training.
- Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
- No informed consent.
- Does not speak Danish on a conversational level.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Simulator Training With or Without Laser Visual Guidance -A Randomized Trial
"Laparoscopic simulation training with or without laser visual guidance -A randomised study" which investigates if the use of laser visual guidance can help the novices to learn the laparoscopic skills.
Read the detailed description
Background: The loss of depth perception due to working in a three-dimensional space based on two-dimensional images is one of the challenging aspects of laparoscopy compared to conventional open surgery.
Objectives: To examine the effect of laser visual guidance on laparoscopic performance and cognitive load in a simulated setting for novices.
Methods: Randomised Clinical Trial- Laser visual guidance vs. normal 2 D vision.
Outcomes:
Primary outcome: Motor skills performance parameters-movement-time:
Cumulative instrument movement-time for both the right and left instrument for the test session,
Secondary outcome: 2) The overall composite score.
Exploratory outcomes: 3) The NASA Task Load index (NASA-TLX).
- Conditions
- Depth Perception
- Being tested
- Laser Visual Guidance, 2 D vision
- Keywords
- Laparoscopy, Training Programs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Visual GuidanceDevice
Laparoscopic simulator training, tested with laser visual guidance
2 D visionDevice
Laparoscopic simulator training, tested without laser visual guidance
| Study group | Role | What they receive |
|---|---|---|
| Laser Visual Guidance group | Experimental | Will be tested using simulated laparoscopic tasks with the use of laser visual guidance Receives: Device: Laser Visual Guidance |
| Normal 2D vision group | Active comparator | Will be tested using simulated laparoscopic tasks without the use of laser visual guidance Receives: Device: 2 D vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor skills performance parameters (Cumulative Instrument movement-time)
Cumulative Instrument movement-time
Measured: 3 hours
Secondary outcomes (1)
The composite performance score (errors)
points
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depth PerceptionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stine Maya Dreier Sørensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars Konge, MD, PhD, Principal investigator, Center for Clinical Education, Rigshospitalet,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407483
- Sponsor's protocol ID
- 2014-6022
- Acronym
- LVG
- Status last verified
- Oct 2018
- First submitted
- 19 Mar 2015
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Simulator Training With or Without Laser Visual Guidance -A Randomized Trial
- ClinicalTrials.gov ID
- NCT02407483
- Acronym / sponsor ID
- LVG / 2014-6022
- Conditions
- Depth Perception
- Keywords
- Laparoscopy, Training Programs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Apr 2015 (estimated)
- 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.
"Laparoscopic simulation training with or without laser visual guidance -A randomised study" which investigates if the use of laser visual guidance can help the novices to learn the laparoscopic skills.
Detailed description
Background: The loss of depth perception due to working in a three-dimensional space based on two-dimensional images is one of the challenging aspects of laparoscopy compared to conventional open surgery.
Objectives: To examine the effect of laser visual guidance on laparoscopic performance and cognitive load in a simulated setting for novices.
Methods: Randomised Clinical Trial- Laser visual guidance vs. normal 2 D vision.
Outcomes:
Primary outcome: Motor skills performance parameters-movement-time:
Cumulative instrument movement-time for both the right and left instrument for the test session,
Secondary outcome: 2) The overall composite score.
Exploratory outcomes: 3) The NASA Task Load index (NASA-TLX).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Visual Guidance group | Experimental | Device: Laser Visual GuidanceWill be tested using simulated laparoscopic tasks with the use of laser visual guidance |
| Normal 2D vision group | Active comparator | Device: 2 D visionWill be tested using simulated laparoscopic tasks without the use of laser visual guidance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Surgical novices / medical students enrolled at The Faculty of Health Science, University of Copenhagen.
- Participants are required to provide informed consent before inclusion.
Key exclusion criteria (4 listed)
- Participation in prior studies involving laparoscopic training.
- Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
- No informed consent.
- Does not speak Danish on a conversational level.
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 |
|---|---|---|
| Laser Visual GuidanceLaparoscopic simulator training, tested with laser visual guidance | Device | Laser Visual Guidance group |
| 2 D visionLaparoscopic simulator training, tested without laser visual guidance | Device | Normal 2D vision group |
Primary outcome
Motor skills performance parameters (Cumulative Instrument movement-time)
Time frame: 3 hours
Cumulative Instrument movement-time
1 secondary outcome
The composite performance score (errors)
Time frame: 3 hours
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 2 Oct 2018.
Related trials for Depth Perception
Not yet recruiting
Investigating Near-Threshold Perception During Ultrasonic Deep Brain Stimulation
Consciousness, Level Altered
Not yet recruiting
Attention-based Binocular Training for Impaired Stereopsis (BRAVE)
Amblyopia, Strabismus
Recruiting
Effectiveness of tDCS in Paediatric Amblyopia.
Amblyopia, Amblyopia Strabismic
Recruiting
Attention and Eye Movement in Parkinson's Disease
Essential Tremor, Parkinson's Disease (PD)
Not yet recruiting
3D Movie Viewing vs Occlusion for Treating Amblyopia in Children
Anisometropic Amblyopia, Strabismic Amblyopia
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.
Lars Konge, MD, PhD principal investigator
Center for Clinical Education, Rigshospitalet,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Visual Guidance and 2 D vision in people with Depth Perception, run by Copenhagen University Hospital, Rigshospitalet 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 2 inclusion and 4 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 2 Oct 2018. 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?
Motor skills performance parameters (Cumulative Instrument movement-time) (time frame: 3 hours). 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 2 Oct 2018.