Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-02-27 @ 3:43 PM
Study NCT ID:
NCT04160104
Status:
UNKNOWN
Last Update Posted:
2019-11-12
First Post:
2019-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-procedure Modle Predicts Bowel Preparation Quality Prior Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1600}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-08', 'studyFirstSubmitDate': '2019-11-08', 'studyFirstSubmitQcDate': '2019-11-08', 'lastUpdatePostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Boston bowel preparation quality scale', 'timeFrame': '1 hour', 'description': 'A 10-point scale (0 is worst, 9 is best)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bowel preparation', 'BBPS'], 'conditions': ['Bowel Preparation', 'Colonoscopy']}, 'descriptionModule': {'briefSummary': "Bowel preparation is closely llined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. For the patients with possible IBP before the examination, it may be better to cancel the colonoscopy and repeat bowel preparation through modified or enhanced strategies. Thus, it is important to set up a model to predict the quality of bowel preparation individually."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a prospective study involving two tertiary-centers in China.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-90 years old who undergoing colonoscopy\n\nExclusion Criteria:\n\n* failed colonoscopy because of technical chanllenge or poor tolerance of patients\n* history of colorectal surgery\n* prior finding of severe colonic stricture or obstructing tumor\n* dysphagia\n* compromised swallowing reflex or mental status\n* significant gastroparesis or gastric outlet obstruction or ileum\n* known or suspected bowel obstruction or perforation\n* pregnancy\n* unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT04160104', 'briefTitle': 'Pre-procedure Modle Predicts Bowel Preparation Quality Prior Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Pre-procedure Modle Predicts Bowel Preparation Quality Prior Colonoscopy', 'orgStudyIdInfo': {'id': 'KT20190827-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Training cohort', 'description': 'This cohort was used to establish the bowel preparation score (BPS).', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Validation cohort', 'description': 'This cohort was used to verify the bowel preparation score (BPS).', 'interventionNames': ['Other: Questionnair']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Patients were asked to complete a questionnaire before colonoscopy. Bowel preparation was subsequently assessed by single endoscopist in each center using Boston bowel preparation quality score (BBPS). Both univariate and multivariate logistic regression models were used to identify high-risk factors associated with IBP and a predicting model with the bowel preparation score (BPS) was developed in the training cohort.', 'armGroupLabels': ['Training cohort']}, {'name': 'Questionnair', 'type': 'OTHER', 'description': 'Patients were asked to complete a questionnaire before colonoscopy. The predicting modle established by the training cohort will be used to assessing the preparation of validation cohort. The result will compared with endoscopists assessment of preparation.', 'armGroupLabels': ['Validation cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Jia, MD', 'role': 'CONTACT', 'email': 'jiahuifmmu@163.com', 'phone': '+862984771536'}, {'name': 'Yanglin Pan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Endoscopic center, Xijing Hospital of Digestive Diseases', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Hui Jia, MD', 'role': 'CONTACT', 'email': 'jiahuifmmu@163.com', 'phone': '+86-2984771536'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'Yanglin Pan', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}