Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-28 @ 1:17 AM
Study NCT ID:
NCT04749303
Status:
UNKNOWN
Last Update Posted:
2021-02-11
First Post:
2021-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Screen Size on Colorectal Adenoma Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Large screen vs standard screen'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 656}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-06', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-06', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma Detection Rate (ADR)', 'timeFrame': '12 months', 'description': "ADR is defined as the proportion of an endoscopist's screening colonoscopies in which one or more adenomas have been detected in patients"}], 'secondaryOutcomes': [{'measure': 'Mean number of adenomas detected per colonoscopy', 'timeFrame': '12 months', 'description': 'Mean number of adenomas detected per colonoscopy found in each arm'}, {'measure': 'Mean number of sessile serrated polyps', 'timeFrame': '12 months', 'description': 'Mean number of sessile serrated polyps found in each arm'}, {'measure': 'Caecal intubation rate', 'timeFrame': '12 months', 'description': 'percentage of caecal intubation rate in each arm'}, {'measure': 'Bowel cleansing level', 'timeFrame': '12 months', 'description': 'According to the Boston bowel preparation scale (0=worst bowel preparation to 9= best bowel preparation). Comparison of each arm.'}, {'measure': 'Procedure Time', 'timeFrame': '12 months', 'description': 'Both intubation and withdrawal time will be recorded. Comparison of each arm.'}, {'measure': 'Severe adverse events', 'timeFrame': '12 months', 'description': 'SAEs of both arms for comparisons'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Adenoma Detection Rate', 'Colorectal cancer screening', 'Screen size'], 'conditions': ['Colon Polyp', 'Colon Adenoma', 'Colorectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether the use of large screen during colonoscopy will increase adenoma detection rate.', 'detailedDescription': 'Colorectal cancer is the 3rd most common cancer in the world. Recently in Hong Kong it has surpassed lung cancer to be the most common cancer. Hence it is essential not only to have up-to-date surgical and oncological treatment but also a need an effective preventative strategy.\n\nIn the past few decades, removal of pre-malignant colonic lesions such as adenomas have been shown to prevent development of colorectal cancers. Colonoscopy is currently the only technique which can perform both detection and treatment during the same procedure. However, concerns have been raised about the effectiveness of colonoscopy in the prevention of CRC after several studies reported unexpected high incidence rates of interval carcinomas (IC), especially in the proximal colon. Most ICs are suspected to arise from missed colon lesions during colonoscopy. Factors concerning missed colonic lesions are multifactorial such as adequate bowel preparation, skill level of endoscopists, the number of endoscopy staff in the room as "eyes" to help with polyp detection and withdrawal time.\n\nFollowing a pilot study in our endoscopy unit, we believe the size of the screen projecting the endoscopic image may have a positive influence on adenoma detection. Therefore, we feel that a well-designed and adequately powered randomised controlled trial may help to confirm this.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or above\n* Referred to the endoscopy unit for diagnostic or surveillance colonoscopy\n\nExclusion Criteria:\n\n* Familial history of Familial adenomatous polyposis or Hereditary non-polyposis colorectal cancer\n* Known history of inflammatory bowel disease\n* Emergency endoscopy of any nature (such as for gastrointestinal bleeding, assessment of large bowel investigation and colonic decompression)\n* Patients with colostomy\n* Previously incomplete colonoscopy (not including insufficient preparation)\n* Patients with known palliative colorectal malignant disease Patients with coagulopathies Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT04749303', 'briefTitle': 'Impact of Screen Size on Colorectal Adenoma Detection', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Impact of Screen Size on Colorectal Adenoma Detection Rate: a Single Centre Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2020.327'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Large screen', 'description': 'This is a high definition screen which gives a 76cm height and 67cm width (area: 5092cm2) endoscopic image.', 'interventionNames': ['Procedure: Large Screen']}, {'type': 'NO_INTERVENTION', 'label': 'Standard screen', 'description': 'This is a high definition screen which gives a 37.5cm height and 32.5cm width (area: 1218.75cm2) endoscopic image.'}], 'interventions': [{'name': 'Large Screen', 'type': 'PROCEDURE', 'otherNames': ['Standard Screen'], 'description': 'Large screen size is 4x larger than standard screen, we hope that the colonoscopies carried out with large screens will confer to better lesion detection', 'armGroupLabels': ['Large screen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Tony WC Mak, MD, FRCS', 'role': 'CONTACT', 'email': 'tonymak@surgery.cuhk.edu.hk', 'phone': '26321495'}, {'name': 'Kaori Futaba, FRCS', 'role': 'CONTACT', 'email': 'kfutaba@surgery.cuhk.edu.hk', 'phone': '35051495'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Tony Wing Chung Mak', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}