Any Symptoms Requiring ColonoscopyNCT02092493
The Effect of ScopeGuide on the Mental Workload of Endoscopist
A study testing ScopeGuide in people with Any Symptoms Requiring Colonoscopy, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
ScopeGuide (Magnetic endoscopic imaging) is a device used during some colonoscopies which provides real-time 3D image of the shape and configuration of the colonoscope as it travels through the colon. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Any Symptoms Requiring Colonoscopy
- What is being tested?
- ScopeGuide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Apr 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All endoscopist performing colonoscopy at University hospital Southampton endoscopy unit
- All adult patients attending diagnostic colonoscopy
Who cannot join
- Endoscopist preference
- Patients unable to give informed consent
- Patient preference
- Patients with new diagnosis of colonic cancer
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton
Southampton, Hamshire, SO16 6YD
About this study
Official title: The Effect of Magnetic Endoscopic Imaging (ScopeGuide) on the Mental Workload of Endoscopists During Colonoscopy
ScopeGuide (Magnetic endoscopic imaging) is a device used during some colonoscopies which provides real-time 3D image of the shape and configuration of the colonoscope as it travels through the colon. Whilst it is being used in clinical practice in most units in the UK, it is not a device which is routinely used on all lists, and most departments do not own enough ScopeGuides to have on all lists. Studies have shown it can potentially aid colonoscopy by improving completion rates and times as well as patient comfort in selected endoscopists (persons who perform the colonoscopy). However data on its benefit have been conflicting.
Subjective mental workload (the individuals mental resources required as a result of the multiple demands placed on him/her from a task)in healthcare employees is known to be important for the performance and safety of healthcare delivery. Increased workload during task performance may increase fatigue, facilitate errors and lead to overall inferior performance.
Read more
In colonoscopy high mental workload could potentially be responsible for longer procedural time, lack of trainee learning, inadvertent missing of lesions in the bowel as well as poor technique leading to patient discomfort. The effect of the endoscopist mental workload on their performance and potential facilitators to reduce mental workload is an area that has been neglected in this field.
This study aims to look at the mental workload of endoscopist during colonoscopy and the effect ScopeGuide may have on this workload.
Hypothesis: The use of ScopeGuide during colonoscopy will reduce the mental workload of the endoscopist performing the procedure
- Conditions
- Any Symptoms Requiring Colonoscopy
- Being tested
- ScopeGuide
- Keywords
- ScopeGuide, Colonoscopy, Mental workload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScopeGuideDevice
Also called Magnetic endoscopic imaging
These patient will have their procedure undertake with the use of ScopeGuide, which provides a 3d configuration of the colonoscope in the patient
| Study group | Role | What they receive |
|---|---|---|
| Non-ScopeGuide | No intervention | This arm will have patients undertaking the procedure without ScopeGuide. All outcome measures will be recorded as usual |
| ScopeGuide | Experimental | Patients have their colonoscopy done with ScopeGuide Receives: Device: ScopeGuide |
What is being measured
The primary outcome is the main question the study is designed to answer.
mental workload scores for endoscopist performing colonoscopy (represented by the NASA-task load index scores on a visual analogue scale (VAS) ranging from 0-600)
This will be a brief VAS scale questionnaire carried out when the endoscopist reaches the caecum
Measured: within 1 hour of beginning procedure
Caecal intubation times, recorded in minutes and seconds
this would be the time it takes from the beginning of the procedure to reaching the caecum
Measured: within 1 hour of beginning procedure
Secondary outcomes (7)
Withdrawal time measured in minutes and second
Measured: within 1 hour of beginning procedure
Overall procedure times in minutes and seconds
Measured: within 1 hour of beginning procedure
-'Timing' of procedures (day & am/pm & order on list)
Measured: upto 1 hour before beginning procedure
Polyp detection
Measured: within 1 hour of beginning procedure
Patient comfort scores on a visual analogue scale
Measured: within 1 hour of completing procedure
Sedation dose measured in milligrams and micrograms
Measured: within 1 hour of completing procedure
Patient pre-endoscopy anxiety levels measured on visual analogue scale
Measured: upto 1 hour before beginning procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Symptoms Requiring ColonoscopyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imdadur Rahman, MBChB MRCP, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092493
- Sponsor's protocol ID
- MEI1
- Status last verified
- Oct 2016
- First submitted
- 12 Mar 2014
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Magnetic Endoscopic Imaging (ScopeGuide) on the Mental Workload of Endoscopists During Colonoscopy
- ClinicalTrials.gov ID
- NCT02092493
- Acronym / sponsor ID
- MEI1
- Conditions
- Any Symptoms Requiring Colonoscopy
- Keywords
- ScopeGuide, Colonoscopy, Mental workload
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Mar 2014 (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.
ScopeGuide (Magnetic endoscopic imaging) is a device used during some colonoscopies which provides real-time 3D image of the shape and configuration of the colonoscope as it travels through the colon. Whilst it is being used in clinical practice in most units in the UK, it is not a device which is routinely used on all lists, and most departments do not own enough ScopeGuides to have on all lists. Studies have shown it can potentially aid colonoscopy by improving completion rates and times as well as patient comfort in selected endoscopists (persons who perform the colonoscopy). However data on its benefit have been conflicting.
Subjective mental workload (the individuals mental resources required as a result of the multiple demands placed on him/her from a task)in healthcare employees is known to be important for the performance and safety of healthcare delivery. Increased workload during task performance may increase fatigue, facilitate errors and lead to overall inferior performance.
In colonoscopy high mental workload could potentially be responsible for longer procedural time, lack of trainee learning, inadvertent missing of lesions in the bowel as well as poor technique leading to patient discomfort. The effect of the endoscopist mental workload on their performance and potential facilitators to reduce mental workload is an area that has been neglected in this field.
This study aims to look at the mental workload of endoscopist during colonoscopy and the effect ScopeGuide may have on this workload.
Hypothesis: The use of ScopeGuide during colonoscopy will reduce the mental workload of the endoscopist performing the procedure
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-ScopeGuide | No intervention | –This arm will have patients undertaking the procedure without ScopeGuide. All outcome measures will be recorded as usual |
| ScopeGuide | Experimental | Device: ScopeGuidePatients have their colonoscopy done with ScopeGuide |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All endoscopist performing colonoscopy at University hospital Southampton endoscopy unit
- All adult patients attending diagnostic colonoscopy
Key exclusion criteria (4 listed)
- Endoscopist preference
- Patients unable to give informed consent
- Patient preference
- Patients with new diagnosis of colonic cancer
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 |
|---|---|---|
| ScopeGuideAlso: Magnetic endoscopic imagingThese patient will have their procedure undertake with the use of ScopeGuide, which provides a 3d configuration of the colonoscope in the patient | Device | ScopeGuide |
Primary outcome
mental workload scores for endoscopist performing colonoscopy (represented by the NASA-task load index scores on a visual analogue scale (VAS) ranging from 0-600)
Time frame: within 1 hour of beginning procedure
This will be a brief VAS scale questionnaire carried out when the endoscopist reaches the caecum
Caecal intubation times, recorded in minutes and seconds
Time frame: within 1 hour of beginning procedure
this would be the time it takes from the beginning of the procedure to reaching the caecum
7 secondary outcomes
Withdrawal time measured in minutes and second
Time frame: within 1 hour of beginning procedure
Overall procedure times in minutes and seconds
Time frame: within 1 hour of beginning procedure
-'Timing' of procedures (day & am/pm & order on list)
Time frame: upto 1 hour before beginning procedure
Polyp detection
Time frame: within 1 hour of beginning procedure
Patient comfort scores on a visual analogue scale
Time frame: within 1 hour of completing procedure
Sedation dose measured in milligrams and micrograms
Time frame: within 1 hour of completing procedure
Patient pre-endoscopy anxiety levels measured on visual analogue scale
Time frame: upto 1 hour before beginning procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
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.
Imdadur Rahman, MBChB MRCP principal investigator
University Hospital Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ScopeGuide in people with Any Symptoms Requiring Colonoscopy, run by University Hospital Southampton NHS Foundation Trust at 1 site 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 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: withdrawn, as of the sponsor's last update on 13 Oct 2016. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
mental workload scores for endoscopist performing colonoscopy (represented by the NASA-task load index scores on a visual analogue scale (VAS) ranging from 0-600) (time frame: within 1 hour of beginning procedure). The study lists 2 primary outcomes in all. 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 13 Oct 2016.