Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2026-01-03 @ 8:17 PM
Study NCT ID:
NCT05397158
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2022-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Intestinal Preparation in Older Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}], 'ancestors': [{'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Endoscopist blind method.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2022-05-18', 'studyFirstSubmitQcDate': '2022-05-27', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intestinal preparation Cleanliness assessment', 'timeFrame': 'Up to 1 hour', 'description': 'The effect of intestinal preparation will be evaluated by Boston Intestinal Preparation Scale.The minimum score is 0，and the maximum score is 9. Higher scores mean a better outcome. Endoscopist blind method will be used.'}], 'secondaryOutcomes': [{'measure': 'Blood potassium level before and after intestinal preparation', 'timeFrame': 'Up to 1 week', 'description': 'Blood potassium in mmol/L.'}, {'measure': 'Blood sodium level before and after intestinal preparation', 'timeFrame': 'Up to 1 week', 'description': 'Blood sodium in mmol/L.'}, {'measure': 'Blood glucose level before and after intestinal preparation', 'timeFrame': 'Up to 1 week', 'description': 'Blood glucose in mmol/L.'}, {'measure': 'B-type brain natriuretic peptide (BNP) level before and after intestinal preparation', 'timeFrame': 'Up to 1 week', 'description': 'BNP in pg/ml.'}, {'measure': 'The situation of comfort during the intestinal preparation', 'timeFrame': 'Two days', 'description': 'Comfort situation questionnaire. The score of comfort questionnaire is 1 to 10, 1 represents extremely uncomfortable and 10 represents very comfortable.'}, {'measure': 'The situation of sleep during the intestinal preparation', 'timeFrame': 'One day', 'description': 'Sleep situation questionnaire. The length of sleep in hour, the number of awakening, the number of urination and defecation.'}, {'measure': 'The situation of fecal incontinence during the intestinal preparation', 'timeFrame': 'One day', 'description': 'Fecal incontinence questionnaire. Does the patient have fecal incontinence and the number of fecal incontinence.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colonoscopy', 'intestinal preparation', 'older adults'], 'conditions': ['Colonoscopy', 'Older Adults']}, 'descriptionModule': {'briefSummary': 'Older adults are susceptible to intestinal tumors. Colonoscopy can screen colorectal cancer, adenoma and other diseases. There is a large demand for colonoscopy in the older adults, and the risk during peri-colonoscopy period is high. According to the common intestinal preparation methods and the characteristics of the older adults, the investigators propose a modified method, that is single administration of low dose polyethylene glycol (PEG). Specifically, take 30ml lactulose in the morning 1 day before the examination, and eat without residue in lunch and dinner, Take 2L PEG in the morning of the examination day and fast at breakfast and lunch of the day. Taking 4L PEG in 2 days as the control group. The fasting and diarrhea period is shorter in the modified group than that in the control group, and the dose of PEG is less. Lactulose, a laxative, is taken one day before the examination, and the intestinal preparation time is longer than that of single administration. The situation of comfort, sleep and fecal incontinence during the intestinal preparation of the two groups will be compared. The results of electrolyte, blood glucose and B-type brain natriuretic peptide between the two groups will be also compared. The effect of intestinal preparation will be evaluated by the standardization of Boston intestinal preparation scale, and endoscopist blind method will be used in colonoscopy.', 'detailedDescription': 'The participants in control group take 2L PEG the day before the examination, fast at dinner (participants without diabetes) and eat without residue (participants with diabetes). Participants take 2L PEG again in the morning of the examination day, and fasted at breakfast and lunch of the day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age≥ 50y\n* Colonoscopy is planned\n* Willing to participate\n\nExclusion Criteria:\n\n* Age\\<50y\n* Unwilling to participate\n* Missing data'}, 'identificationModule': {'nctId': 'NCT05397158', 'briefTitle': 'Optimization of Intestinal Preparation in Older Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tongren Hospital'}, 'officialTitle': 'Study on Optimization of Intestinal Preparation Before Colonoscopy in Older Patients', 'orgStudyIdInfo': {'id': 'YuHe'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single administration of low dose polyethylene glycol group', 'description': 'The patients take 30ml lactulose in the morning 1 day before the examination, and eat without residue in lunch and dinner; Take 2L PEG in the morning of the examination day and fast at breakfast and lunch of the day.', 'interventionNames': ['Procedure: single administration of low dose polyethylene glycol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'The patients in control group take 2L PEG the day before the examination, fast at dinner (patients without diabetes) and eat without residue (patients with diabetes). Patients take 2L PEG again in the morning of the examination day, and fasted at breakfast and lunch of the day.', 'interventionNames': ['Procedure: single administration of low dose polyethylene glycol']}], 'interventions': [{'name': 'single administration of low dose polyethylene glycol', 'type': 'PROCEDURE', 'description': 'Patients in single administration of low dose polyethylene glycol (PEG) group: Take 30ml lactulose and 2L PEG.\n\nPatients in control group: Take 4L PEG.', 'armGroupLabels': ['Single administration of low dose polyethylene glycol group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tongren Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}