Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT02092493
Status:
WITHDRAWN
Last Update Posted:
2016-10-13
First Post:
2014-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of ScopeGuide on the Mental Workload of Endoscopist
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2014-03-12', 'studyFirstSubmitQcDate': '2014-03-18', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'timeFrame': 'within 1 hour of beginning procedure', 'description': 'This will be a brief VAS scale questionnaire carried out when the endoscopist reaches the caecum'}, {'measure': 'Caecal intubation times, recorded in minutes and seconds', 'timeFrame': 'within 1 hour of beginning procedure', 'description': 'this would be the time it takes from the beginning of the procedure to reaching the caecum'}], 'secondaryOutcomes': [{'measure': 'Withdrawal time measured in minutes and second', 'timeFrame': 'within 1 hour of beginning procedure'}, {'measure': 'Overall procedure times in minutes and seconds', 'timeFrame': 'within 1 hour of beginning procedure'}, {'measure': "-'Timing' of procedures (day & am/pm & order on list)", 'timeFrame': 'upto 1 hour before beginning procedure'}, {'measure': 'Polyp detection', 'timeFrame': 'within 1 hour of beginning procedure'}, {'measure': 'Patient comfort scores on a visual analogue scale', 'timeFrame': 'within 1 hour of completing procedure'}, {'measure': 'Sedation dose measured in milligrams and micrograms', 'timeFrame': 'within 1 hour of completing procedure'}, {'measure': 'Patient pre-endoscopy anxiety levels measured on visual analogue scale', 'timeFrame': 'upto 1 hour before beginning procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ScopeGuide', 'Colonoscopy', 'Mental workload'], 'conditions': ['Any Symptoms Requiring Colonoscopy']}, 'descriptionModule': {'briefSummary': '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.\n\nSubjective 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.\n\nIn 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.\n\nThis study aims to look at the mental workload of endoscopist during colonoscopy and the effect ScopeGuide may have on this workload.\n\nHypothesis: The use of ScopeGuide during colonoscopy will reduce the mental workload of the endoscopist performing the procedure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All endoscopist performing colonoscopy at University hospital Southampton endoscopy unit\n* All adult patients attending diagnostic colonoscopy\n\nExclusion Criteria:\n\n* Endoscopist preference\n* Patients unable to give informed consent\n* Patient preference\n* Patients with new diagnosis of colonic cancer'}, 'identificationModule': {'nctId': 'NCT02092493', 'briefTitle': 'The Effect of ScopeGuide on the Mental Workload of Endoscopist', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Southampton NHS Foundation Trust'}, 'officialTitle': 'The Effect of Magnetic Endoscopic Imaging (ScopeGuide) on the Mental Workload of Endoscopists During Colonoscopy', 'orgStudyIdInfo': {'id': 'MEI1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Non-ScopeGuide', 'description': 'This arm will have patients undertaking the procedure without ScopeGuide. All outcome measures will be recorded as usual'}, {'type': 'EXPERIMENTAL', 'label': 'ScopeGuide', 'description': 'Patients have their colonoscopy done with ScopeGuide', 'interventionNames': ['Device: ScopeGuide']}], 'interventions': [{'name': 'ScopeGuide', 'type': 'DEVICE', 'otherNames': ['Magnetic endoscopic imaging'], 'description': 'These patient will have their procedure undertake with the use of ScopeGuide, which provides a 3d configuration of the colonoscope in the patient', 'armGroupLabels': ['ScopeGuide']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'Hamshire', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Imdadur Rahman, MBChB MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Southampton NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Southampton NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}