Laparoscopic TrainingLapACQNCT03407235
Simulating Laparoscopy With an Eye Patch
A study testing Computerized Laparoscopic Trainer and Box trainer with eye patch in people with Laparoscopic Training, run by University of Nottingham at 2 sites in United Kingdom.
Trial summary
Comparison of laparoscopic training simulator v use of eye patch (to simulate loss of dept perception) to investigate acquisition of laparoscopic skills. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Training
- What is being tested?
- Computerized Laparoscopic Trainer and Box trainer with eye patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 11 Dec 2017to 1 Aug 2018
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Laparoscopic Novices
- 20-40 years
- All genders
Who cannot join
- Previous laparoscopic surgical experience
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Of Nottingham
Derby, DE22 3NE
The Medical School, University of Nottingham, Royal Derby Hospital.
Derby, DE22
About this study
Official title: Laparoscopic Skill Acquisition; Can the Loss of Depth Perception Associated With Laparoscopic Surgery be Adequately Simulated by an Eye Patch?
Comparison of laparoscopic training simulator v use of eye patch (to simulate loss of dept perception) to investigate acquisition of laparoscopic skills.
Read the detailed description
Healthy volunteers who are laparoscopic novices will perform four validated laparoscopic training exercises on both the laparoscopic computerized trainer and on a simple box trainer with an eye patch.
Novices will be allowed to familiarize themselves with the laparoscopic instruments and will be shown short video clips to demonstrate tasks.
They then will have five minutes to complete each of the four tasks. They will return 1-2 weeks later to complete the same process on the alternative training method.
All participants will complete the tasks on both the computerized lap simulator and the box trainer.
- Conditions
- Laparoscopic Training
- Being tested
- Computerized Laparoscopic Trainer, Box trainer with eye patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Laparoscopic TrainerDevice
Gold standard laparoscopic trainer using simulated computerized equipment.
Box trainer with eye patchDevice
Simple, cost effective box trainer, with loss of dept perception achieved with use of eye patch
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Novices | Other | Four laparoscopic task will be undertaken on a computerized laparoscopic trainer and box trainer with eye patch.
Time to completion is recorded. Receives: Device: Computerized Laparoscopic Trainer; Device: Box trainer with eye patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to completion of laparoscopic tasks.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start11 Dec 2017
- Primary completion1 May 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407235
- Sponsor's protocol ID
- LTf15082013 ammend. 2
- Acronym
- LapACQ
- Status last verified
- Dec 2017
- First submitted
- 16 Jan 2018
- Last updated
- 15 Oct 2018
- 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 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Skill Acquisition; Can the Loss of Depth Perception Associated With Laparoscopic Surgery be Adequately Simulated by an Eye Patch?
- ClinicalTrials.gov ID
- NCT03407235
- Acronym / sponsor ID
- LapACQ / LTf15082013 ammend. 2
- Conditions
- Laparoscopic Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 23 Jan 2018 (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.
Comparison of laparoscopic training simulator v use of eye patch (to simulate loss of dept perception) to investigate acquisition of laparoscopic skills.
Detailed description
Healthy volunteers who are laparoscopic novices will perform four validated laparoscopic training exercises on both the laparoscopic computerized trainer and on a simple box trainer with an eye patch.
Novices will be allowed to familiarize themselves with the laparoscopic instruments and will be shown short video clips to demonstrate tasks.
They then will have five minutes to complete each of the four tasks. They will return 1-2 weeks later to complete the same process on the alternative training method.
All participants will complete the tasks on both the computerized lap simulator and the box trainer.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Novices | Other | Device: Computerized Laparoscopic Trainer, Device: Box trainer with eye patchFour laparoscopic task will be undertaken on a computerized laparoscopic trainer and box trainer with eye patch. Time to completion is recorded. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Laparoscopic Novices
- 20-40 years
- All genders
Key exclusion criteria (1 listed)
- Previous laparoscopic surgical experience
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 |
|---|---|---|
| Computerized Laparoscopic TrainerGold standard laparoscopic trainer using simulated computerized equipment. | Device | Laparoscopic Novices |
| Box trainer with eye patchSimple, cost effective box trainer, with loss of dept perception achieved with use of eye patch | Device | Laparoscopic Novices |
Primary outcome
Time to completion of laparoscopic tasks.
Time frame: 5 minutes
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 15 Oct 2018.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Laparoscopic Trainer and Box trainer with eye patch in people with Laparoscopic Training, run by University of Nottingham at 2 sites in United Kingdom.
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 1 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 15 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 2 sites in United Kingdom. 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 completion of laparoscopic tasks. (time frame: 5 minutes). 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 15 Oct 2018.