The Effect of ScopeGuide on the Mental Workload of Endoscopist

NCT ID: NCT02092493

Last Updated: 2016-10-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-04-30

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

Conditions

Any Symptoms Requiring Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Non-ScopeGuide

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

ScopeGuide

Patients have their colonoscopy done with ScopeGuide

Group Type: EXPERIMENTAL

ScopeGuide

Intervention Type: DEVICE

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

Interventions

ScopeGuide

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

Intervention Type: DEVICE

Other Intervention Names

Magnetic endoscopic imaging

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Imdadur Rahman, MBChB MRCP

Role: PRINCIPAL_INVESTIGATOR

University Hospital Southampton NHS Foundation Trust

Locations

University Hospital Southampton

Southampton, Hamshire, United Kingdom

Countries

United Kingdom

Other Identifiers

MEI1

Identifier Type: -

Identifier Source: org_study_id