Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-31 @ 7:29 AM
Study NCT ID:
NCT01286961
Status:
COMPLETED
Last Update Posted:
2011-10-05
First Post:
2011-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C033608', 'term': 'Golytely'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-04', 'studyFirstSubmitDate': '2011-01-31', 'studyFirstSubmitQcDate': '2011-01-31', 'lastUpdatePostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of bowel preparation according to Ottawa scale', 'timeFrame': '6 months', 'description': 'The primary end point of the study was to assess the quality of bowel preparation according to the Ottawa scale, including cleanliness and fluid quantity.'}], 'secondaryOutcomes': [{'measure': 'Proper timing of colonoscopy', 'timeFrame': '6 months', 'description': 'The secondary end points was to determine the proper interval between the completion of spliting bowel preparation and the start of colonoscopy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bowel preparation', 'Polyethylene glycols', 'Colonoscopy', 'Outpatient'], 'conditions': ['The Timing of Bowel Preparation in Outpatient Colonoscopy']}, 'descriptionModule': {'briefSummary': 'As the duration of the interval between the time of last preparation-agent dose and the start of the colonoscopy is increasing, the quality of bowel preparation will be worse.', 'detailedDescription': 'The aim of the present studies is to determine how the duration of the interval of the time of last preparation dose and the start of colonoscopy affects the quality of the bowel preparation and when the proper timing of the colonoscopy is after completion of last preparation regimen'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult outpatients who undergo colonoscopy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult outpatients(18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms\n\nExclusion Criteria:\n\n* age under 18 years, pregnancy, breast feeding, prior history of surgical large bowel resection, severe renal failure (creatinine ≥ 3.0mg/dL (normal 0.8-1.4)), drug addiction or major psychiatric illness; allergy to PEG, refusal of consent to participate in the study.'}, 'identificationModule': {'nctId': 'NCT01286961', 'acronym': 'TOSP', 'briefTitle': 'The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy', 'orgStudyIdInfo': {'id': 'HGI 2011-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'outpatient colonoscopy, bowel preparation, split dose PEG', 'description': 'adult outpatients who undergo colonoscopy', 'interventionNames': ['Drug: bowel preparation using split dose of polyethylene glycol']}], 'interventions': [{'name': 'bowel preparation using split dose of polyethylene glycol', 'type': 'DRUG', 'otherNames': ['Colyte'], 'description': 'polyethylene glycol, split dose(2L/2L), each dose for 1-2hours', 'armGroupLabels': ['outpatient colonoscopy, bowel preparation, split dose PEG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '612-030', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Haeundae Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'overallOfficials': [{'name': 'Tae Oh Kim, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inje University School of Medicine, Haeundae Paik Hospital, Internal Medicine'}, {'name': 'Eun Hee Seo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University School of Medicine, Haeundae Paik Hospital, Internal Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'fellow', 'investigatorFullName': 'Eun Hee Seo', 'investigatorAffiliation': 'Inje University'}}}}