Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT01142167
Status:
COMPLETED
Last Update Posted:
2013-07-31
First Post:
2010-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of an Ultra-thin and Standard Colonoscope in Achieving Caecal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-29', 'studyFirstSubmitDate': '2010-06-09', 'studyFirstSubmitQcDate': '2010-06-10', 'lastUpdatePostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful Caecal intubation', 'timeFrame': '12 weeks', 'description': 'Success of Caecal intubation for the ultra-thin colonoscope vs standard colonoscope'}], 'secondaryOutcomes': [{'measure': 'Caecal intubation time', 'timeFrame': '12 weeks', 'description': 'Caecal intubation time Ultra-thin colonsocope vs standard colonoscope'}, {'measure': 'Patient Satisfaction and Pain score', 'timeFrame': '12 weeks', 'description': 'Patient tolerability Ultra-thin vs standard colonoscope'}, {'measure': 'Endoscopist satisfaction', 'timeFrame': '12 weeks', 'description': 'Ease of use prototype scope vs standard colonoscope'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ultra-thin colonoscope'], 'conditions': ['First Colonoscopy Examination']}, 'referencesModule': {'references': [{'pmid': '21963069', 'type': 'DERIVED', 'citation': 'Luo DJ, Hui AJ, Yan KK, Ng SC, Wong VW, Chan FK, Cheong JP, Lam PP, Tse YK, Lau JY. A randomized comparison of ultrathin and standard colonoscope in cecal intubation rate and patient tolerance. Gastrointest Endosc. 2012 Mar;75(3):484-90. doi: 10.1016/j.gie.2011.07.032. Epub 2011 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to study the caecal intubation rate of a prototype ultra-thin colonoscope compared to a standard colonoscope and to study usefulness of this new colonoscope as a rescue instrument for failed initial colonoscopy with a standard colonoscope and to study the patient satisfaction scores using a validated endoscopy GHAA-9 for a new prototype colonoscope as compared to a standard colonoscope.', 'detailedDescription': 'Colonoscopy is a common endoscopic procedure, widely used for the investigation of lower gastrointestinal tract diseases manifesting as altered bowel habit, per rectal bleeding and abdominal pain. It is used to diagnose colonic polyps, colorectal cancer and inflammatory bowel disease to name a few examples.\n\nColorectal cancer screening has been shown to decrease colorectal cancer. Despite this the uptake by the general population is suboptimal.\n\nA new prototype colonoscope from Olympus with an additional distal bending section was designed. The investigators hypothesize that its performance characteristics will be similar to a standard colonoscope with patient tolerability.\n\nThis randomised control trial aims to invite patients attending their first outpatient colonoscopy and who are able to provide informed consent.(so they have had no prior experience) to assess the completion rate, patient and endoscopist satisfaction.\n\nPatients with prior colorectal surgery or previous colonoscopy were excluded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First outpatient colonoscopy\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Prior colon surgery (except appendectomy)'}, 'identificationModule': {'nctId': 'NCT01142167', 'briefTitle': 'A Comparison of an Ultra-thin and Standard Colonoscope in Achieving Caecal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A Study to Assess the Success Rate of Ultra-thin Colonoscopy Versus Conventional Colonoscopy for the First or Rescue Colonoscopy for Unsuccessful Procedures (UTC Study).', 'orgStudyIdInfo': {'id': 'UTC Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Colonoscopy', 'description': 'Colonoscopy with standard instrument', 'interventionNames': ['Procedure: Standard Colonoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Ultra-thin colonoscopy', 'description': 'New prototype scope', 'interventionNames': ['Procedure: Ultra-thin colonoscopy']}], 'interventions': [{'name': 'Standard Colonoscopy', 'type': 'PROCEDURE', 'description': 'Standard colonoscopy will be used during colonoscopy', 'armGroupLabels': ['Standard Colonoscopy']}, {'name': 'Ultra-thin colonoscopy', 'type': 'PROCEDURE', 'description': 'Ultra-thin colonoscope will be used during colonoscopy', 'armGroupLabels': ['Ultra-thin colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'China', 'facility': 'Endoscopy Center, Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'James Y Lau', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'James Yun-wong Lau', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}