The Effect of ScopeGuide on the Mental Workload of Endoscopist

Sponsor

University Hospital Southampton NHS Foundation Trust (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02092493

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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

Condition or Disease	Intervention/Treatment	Phase
Any Symptoms Requiring Colonoscopy	Device: ScopeGuide	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Magnetic Endoscopic Imaging (ScopeGuide) on the Mental Workload of Endoscopists During Colonoscopy

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Non-ScopeGuide This arm will have patients undertaking the procedure without ScopeGuide. All outcome measures will be recorded as usual
Experimental: ScopeGuide Patients have their colonoscopy done with ScopeGuide	Device: ScopeGuide These patient will have their procedure undertake with the use of ScopeGuide, which provides a 3d configuration of the colonoscope in the patient Other Names: Magnetic endoscopic imaging

Arm

Intervention/Treatment

No Intervention: Non-ScopeGuide

This arm will have patients undertaking the procedure without ScopeGuide. All outcome measures will be recorded as usual

Experimental: ScopeGuide

Patients have their colonoscopy done with ScopeGuide

Device: ScopeGuide

These patient will have their procedure undertake with the use of ScopeGuide, which provides a 3d configuration of the colonoscope in the patient

Other Names:

Magnetic endoscopic imaging

Outcome Measures

Primary Outcome Measures

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) [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 [within 1 hour of beginning procedure]
this would be the time it takes from the beginning of the procedure to reaching the caecum

Secondary Outcome Measures

Withdrawal time measured in minutes and second [within 1 hour of beginning procedure]
Overall procedure times in minutes and seconds [within 1 hour of beginning procedure]
-'Timing' of procedures (day & am/pm & order on list) [upto 1 hour before beginning procedure]
Polyp detection [within 1 hour of beginning procedure]
Patient comfort scores on a visual analogue scale [within 1 hour of completing procedure]
Sedation dose measured in milligrams and micrograms [within 1 hour of completing procedure]
Patient pre-endoscopy anxiety levels measured on visual analogue scale [upto 1 hour before beginning procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Southampton	Southampton	Hamshire	United Kingdom	SO16 6YD

Sponsors and Collaborators

University Hospital Southampton NHS Foundation Trust

Investigators

Principal Investigator: Imdadur Rahman, MBChB MRCP, University Hospital Southampton NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Southampton NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT02092493

Other Study ID Numbers:

MEI1

First Posted:

Mar 20, 2014

Last Update Posted:

Oct 13, 2016

Last Verified:

Oct 1, 2016

Keywords provided by University Hospital Southampton NHS Foundation Trust

ScopeGuide

Colonoscopy

Mental workload

Study Results

No Results Posted as of Oct 13, 2016