Any Symptoms Requiring Colonoscopy Clinical Trial
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.
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
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 99 Years |
| Eligibility |
Inclusion Criteria: - All endoscopist performing colonoscopy at University hospital Southampton endoscopy unit - All adult patients attending diagnostic colonoscopy Exclusion Criteria: - Endoscopist preference - Patients unable to give informed consent - Patient preference - Patients with new diagnosis of colonic cancer |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University Hospital Southampton | Southampton | Hamshire |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Southampton NHS Foundation Trust. |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | within 1 hour of beginning procedure | No |
| Primary | 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 | within 1 hour of beginning procedure | No |
| Secondary | Withdrawal time measured in minutes and second | within 1 hour of beginning procedure | No | |
| Secondary | Overall procedure times in minutes and seconds | within 1 hour of beginning procedure | No | |
| Secondary | -'Timing' of procedures (day & am/pm & order on list) | upto 1 hour before beginning procedure | No | |
| Secondary | Polyp detection | within 1 hour of beginning procedure | No | |
| Secondary | Patient comfort scores on a visual analogue scale | within 1 hour of completing procedure | No | |
| Secondary | Sedation dose measured in milligrams and micrograms | within 1 hour of completing procedure | No | |
| Secondary | Patient pre-endoscopy anxiety levels measured on visual analogue scale | upto 1 hour before beginning procedure | No |