Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-02-27 @ 10:05 AM
Study NCT ID:
NCT02726893
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2016-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Predictive Model for Inadequate Bowel Preparation Before Colonoscopy: Development and Validation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1504}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-16', 'studyFirstSubmitDate': '2016-03-25', 'studyFirstSubmitQcDate': '2016-03-29', 'lastUpdatePostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) score.', 'timeFrame': '5 months', 'description': 'inadequate bowel preparation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bowel Cleansing Quality', 'Predictors', 'Colonoscopy', 'Boston Bowel Preparation Scale']}, 'descriptionModule': {'briefSummary': 'About 30% of patients were reported to suffer inadequate bowel preparation.', 'detailedDescription': 'Risk factors, such as diabetes, constipation, history of intra-abdominal or pelvic surgery, etc, have been demonstrated to be important predictors for inadequate bowel preparation. The aim of the study is to create and verify a predictive model for inadequate bowel preparation in Chinese.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. patients undergoing colonoscopy.\n2. patients older than 18 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing colonoscopy.\n* patients older than 18 years.\n\nExclusion Criteria:\n\n* patients referred for emergency colonoscopy.'}, 'identificationModule': {'nctId': 'NCT02726893', 'briefTitle': 'A Predictive Model for Inadequate Bowel Preparation Before Colonoscopy: Development and Validation', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'A Predictive Model for Inadequate Bowel Preparation Before Colonoscopy: Development and Validation', 'orgStudyIdInfo': {'id': '2016SDU-QILU-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients undergoing colonoscopy', 'description': 'patients undergoing colonoscopy were observed in terms of the bowel preparation quality which is measured by Boston Bowel Preparation Scale (BBPS).', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'armGroupLabels': ['patients undergoing colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Department of Gastroenterology, Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'Li Yanqing, PhD,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital, Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of Qilu Hospital', 'investigatorFullName': 'Yanqing Li', 'investigatorAffiliation': 'Shandong University'}}}}