Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
Study NCT ID:
NCT01124266
Status:
COMPLETED
Last Update Posted:
2011-02-17
First Post:
2010-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011127', 'term': 'Polyps'}, {'id': 'D018256', 'term': 'Adenomatous Polyps'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 844}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-16', 'studyFirstSubmitDate': '2010-05-14', 'studyFirstSubmitQcDate': '2010-05-14', 'lastUpdatePostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adenoma detection rate', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'subjects with at least one polyp', 'timeFrame': '1 year'}, {'measure': 'Subjects with at least one adenoma', 'timeFrame': '1 year'}, {'measure': 'total number of polyp', 'timeFrame': '1 year'}, {'measure': 'total number of adenoma', 'timeFrame': '1 year'}, {'measure': 'Subjects with at least one advanced adenoma or cancer', 'timeFrame': '1 year'}, {'measure': 'total number of advanced adenoma or cancer', 'timeFrame': '1 year'}, {'measure': 'polyp and adenoma detection rate according to the endoscopists or nurse experience', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['polyp', 'adenoma', 'screening', 'colonoscopy', 'diagnosis'], 'conditions': ['Polyp', 'Adenomatous Polyp', 'Colonoscopy']}, 'referencesModule': {'references': [{'pmid': '18759826', 'type': 'BACKGROUND', 'citation': 'Rogart JN, Siddiqui UD, Jamidar PA, Aslanian HR. Fellow involvement may increase adenoma detection rates during colonoscopy. Am J Gastroenterol. 2008 Nov;103(11):2841-6. doi: 10.1111/j.1572-0241.2008.02085.x. Epub 2008 Aug 27.'}, {'pmid': '20117245', 'type': 'BACKGROUND', 'citation': 'Peters SL, Hasan AG, Jacobson NB, Austin GL. Level of fellowship training increases adenoma detection rates. Clin Gastroenterol Hepatol. 2010 May;8(5):439-42. doi: 10.1016/j.cgh.2010.01.013. Epub 2010 Feb 1.'}, {'pmid': '21889137', 'type': 'DERIVED', 'citation': 'Lee CK, Park DI, Lee SH, Hwangbo Y, Eun CS, Han DS, Cha JM, Lee BI, Shin JE. Participation by experienced endoscopy nurses increases the detection rate of colon polyps during a screening colonoscopy: a multicenter, prospective, randomized study. Gastrointest Endosc. 2011 Nov;74(5):1094-102. doi: 10.1016/j.gie.2011.06.033. Epub 2011 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'Colorectal cancer (CRC) is the second most common cancer and the fourth leading cause of cancer death in Korea. Colonoscopy with polypectomy decreases the incidence and mortality from colorectal cancer. However, significant lesions can be missed during colonoscopy. Recent retrospective studies have shown that fellow involvement as a second observer may increase adenoma detection rate in colonoscopy.\n\nThe aim of this prospective, multicenter, randomized study is to evaluate the impact when endoscopy nurse participate in adenoma detection during screening colonoscopy. The primary outcome measure is the adenoma detection rate (ADR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 50\n* screening colonoscopy\n\nExclusion Criteria:\n\n* History of colorectal surgery\n* History of hereditary colorectal cancers or polyposis syndrome\n* Gastrointestinal bleeding\n* Inflammatory bowel diseases\n* Inability to provide informed consent\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01124266', 'briefTitle': 'Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Soon Chun Hyang University'}, 'officialTitle': 'Can Involvement of Endoscopy Nurse Participation Increase Adenoma Detection Rate During Screening Colonoscopy?:A Prospective Multicenter Randomized Trial', 'orgStudyIdInfo': {'id': '2010-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'endoscopist only', 'interventionNames': ['Procedure: standard of care colonoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'nurse participation', 'interventionNames': ['Procedure: standard of care colonoscopy']}], 'interventions': [{'name': 'standard of care colonoscopy', 'type': 'PROCEDURE', 'description': 'Single inspection by endoscopist during colonoscopy', 'armGroupLabels': ['endoscopist only']}, {'name': 'standard of care colonoscopy', 'type': 'PROCEDURE', 'description': 'Dual inspection by both endoscopist and nurse during colonoscopy', 'armGroupLabels': ['nurse participation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Dankook University Hospital', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Cheonan', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Cheonan Hospital', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Guri-si', 'country': 'South Korea', 'facility': 'Hanyang university Guri Hospital', 'geoPoint': {'lat': 37.5986, 'lon': 127.1394}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': "The Catholic University Incheon St. Mary's Hospital", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Gangdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Chang Kyun Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soon Chun Hyang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soon Chun Hyang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kangbuk Samsung Hospital', 'class': 'OTHER'}, {'name': 'Hanyang University', 'class': 'OTHER'}, {'name': 'Dankook University', 'class': 'OTHER'}, {'name': "Incheon St.Mary's Hospital", 'class': 'OTHER'}, {'name': 'Kyung Hee University Hospital at Gangdong', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Chang Kyun Lee, MD, PhD', 'oldOrganization': 'Soon Chung Hyang Universtiy, Cheonan Hospital'}}}}