Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-03-01 @ 5:01 PM
Study NCT ID:
NCT01925833
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2013-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adenoma Detection by Polypectomy During Both Insertion and Withdrawal
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': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-09', 'studyFirstSubmitDate': '2013-08-16', 'studyFirstSubmitQcDate': '2013-08-16', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Polyp miss rate', 'timeFrame': '4 weeks'}], 'primaryOutcomes': [{'measure': 'Adenoma detection rate', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of adenoma per patient', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adenoma of Large Intestine']}, 'referencesModule': {'references': [{'pmid': '31953727', 'type': 'DERIVED', 'citation': 'Gweon TG, Lee SW, Ji JS, Lee JR, Kim JS, Kim BW, Choi H. Comparison of adenoma detection by colonoscopy between polypectomy performed during both insertion and withdrawal versus during withdrawal only: a multicenter, randomized, controlled trial. Surg Endosc. 2020 Dec;34(12):5461-5468. doi: 10.1007/s00464-019-07342-4. Epub 2020 Jan 17.'}]}, 'descriptionModule': {'briefSummary': 'Standard method of colonoscopy is to insert the colonoscope rapidly to reach the cecum, with careful inspection and polypectomy during the withdrawal phase. However, small polyps (e.g. \\<1cm) seen during insertion phase are difficult to find during withdrawal phase. Also, colon is in different conformation during insertion and withdrawal phases. We think careful inspection and polypectomy during both insertion and withdrawal can improve adenoma detection rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing screening or surveillance colonoscopy\n\nExclusion Criteria:\n\n* Previous colorectal resection, Polyposis syndrome, Inflammatory bowel disease'}, 'identificationModule': {'nctId': 'NCT01925833', 'briefTitle': 'Adenoma Detection by Polypectomy During Both Insertion and Withdrawal', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Comparison of Adenoma Detection by Polypectomy During Both Insertion and Withdrawal Versus Only Withdrawal of Colonoscopy: a Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'Insertion'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Both insertion and withdrawal', 'interventionNames': ['Procedure: Both insertion and withdrawal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Only withdrawal', 'interventionNames': ['Procedure: Only withdrawal']}], 'interventions': [{'name': 'Both insertion and withdrawal', 'type': 'PROCEDURE', 'description': 'inspection and polypectomy during both insertion and withdrawal of colonoscopy', 'armGroupLabels': ['Both insertion and withdrawal']}, {'name': 'Only withdrawal', 'type': 'PROCEDURE', 'description': 'inspection and polypectomy during only withdrawal of colonoscopy', 'armGroupLabels': ['Only withdrawal']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Jeong-Seon Ji', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}