Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT01169220
Status:
COMPLETED
Last Update Posted:
2017-10-05
First Post:
2010-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bowel Preparation for Inpatient Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-10-15', 'releaseDate': '2021-09-20'}, {'resetDate': '2022-11-15', 'releaseDate': '2022-10-25'}], 'estimatedResultsFirstSubmitDate': '2021-09-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D004240', 'term': 'Diverticulum'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-03', 'studyFirstSubmitDate': '2010-07-20', 'studyFirstSubmitQcDate': '2010-07-23', 'lastUpdatePostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of colon cleansing', 'timeFrame': '24 hours from study enrollment'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '24 hours from study enrollment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Bowel preparation'], 'conditions': ['Gastrointestinal Hemorrhage', 'Colon Cancer', 'Diverticulosis']}, 'descriptionModule': {'briefSummary': 'This study will compare two strategies for bowel cleansing prior to inpatient colonoscopy: the entire preparation taken the night before the procedure versus half the preparation taken the night before the procedure, and the other half taken the morning of the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any diagnosis for which colonoscopy is indicated\n\nExclusion Criteria:\n\n* ileus\n* severe colitis/toxic megacolon\n* gastric retention\n* bowel perforation\n* gastrointestinal obstruction\n* gastroparesis that precludes oral bowel preparation\n* pregnant or lactating women\n* allergy to polyethylene glycol.\n* unable to give consent'}, 'identificationModule': {'nctId': 'NCT01169220', 'briefTitle': 'Bowel Preparation for Inpatient Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Santa Clara Valley Health & Hospital System'}, 'officialTitle': 'Single Blind, Randomized, Controlled Trial of Conventional Versus Split-Dose Bowel Preparation for Inpatient Colonoscopy', 'orgStudyIdInfo': {'id': '10-041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Split prep', 'interventionNames': ['Drug: Go Lytely']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whole prep', 'interventionNames': ['Drug: Go-Lytely']}], 'interventions': [{'name': 'Go-Lytely', 'type': 'DRUG', 'description': 'Bowel cleansing agent', 'armGroupLabels': ['Whole prep']}, {'name': 'Go Lytely', 'type': 'DRUG', 'description': 'Bowel cleansing agent', 'armGroupLabels': ['Split prep']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95128', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Santa Clara Valley Medical Center', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santa Clara Valley Health & Hospital System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-09-20', 'type': 'RELEASE'}, {'date': '2021-10-15', 'type': 'RESET'}, {'date': '2022-10-25', 'type': 'RELEASE'}, {'date': '2022-11-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Santa Clara Valley Health & Hospital System'}}}}