Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-06 @ 4:31 AM
Study NCT ID:
NCT04948567
Status:
COMPLETED
Last Update Posted:
2021-07-02
First Post:
2021-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Split-dose of Oral MMS for Bowel Preparation in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-24', 'studyFirstSubmitDate': '2021-05-27', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of patients with adequate bowel preparation', 'timeFrame': '1 year', 'description': 'Defined by each segmental BBPS≥2'}], 'secondaryOutcomes': [{'measure': 'The rate of adenoma detection', 'timeFrame': '1 year', 'description': 'The proportion of participants with at least one adenoma in each group'}, {'measure': 'the numbers of patients with adverse events', 'timeFrame': '1 year', 'description': 'eg. Vomiting, nausea, abdominal pain'}, {'measure': 'The cecal intubation rate', 'timeFrame': '1 year', 'description': 'The rate of colonoscopy reaching the cecum'}, {'measure': 'The time of Cecal intubation', 'timeFrame': 'during procedure', 'description': 'the time between the intubation and visualization of any of the following anatomic landmarks: ileocecal valve, appendiceal orifice, or terminal ileum'}, {'measure': 'the time during Withdrawal phage', 'timeFrame': 'during procedure', 'description': 'the inspection time from cecum to rectum'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bowel preparation', 'Oral magnesium sulfate solution', 'polyethylene glycol solution'], 'conditions': ['Colonic Adenoma', 'Bowel Preparation']}, 'referencesModule': {'references': [{'pmid': '35920250', 'type': 'DERIVED', 'citation': 'Ge F, Kang X, Wang Z, Zhu H, Liao L, Wang M, Jia J, Lou L, Guo X, Pan Y, Wan J. Low-dose of magnesium sulfate solution was not inferior to standard regime of polyethylene glycol for bowel preparation in elderly patients: a randomized, controlled study. Scand J Gastroenterol. 2023 Jan;58(1):94-100. doi: 10.1080/00365521.2022.2106154. Epub 2022 Aug 3.'}]}, 'descriptionModule': {'briefSummary': 'Adequate bowel preparation is critical for successful colonoscopy and a large volume of PEG was required for bowel preparation in patients undergoing colonoscopy. The investigators conducted a a prospective, randomized, controlled study to compare low dose of oral magnesium sulfate solution with high dose PEG. The investigators found that patients who took low dose of oral magnesium sulfate solution had similar bowel preparation quality to patients who took PEG,but accompanied with fewer adverse events and better tolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent colonoscopy\n\nExclusion Criteria:\n\n* known or suspected bowel stricture or obstruction;\n* history of colorectal surgery;\n* significant gastroparesis or gastric outlet obstruction;\n* toxic colitis or megacolon;\n* severe acute inflammatory bowel disease;\n* active gastrointestinal bleeding;\n* suspected or confirmed chronic renal insufficiency and heart illness;\n* disturbance of electrolytes ;\n* unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04948567', 'briefTitle': 'Efficacy of Split-dose of Oral MMS for Bowel Preparation in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Efficacy of Split-dose of Oral Magnesium Sulfate Solution for Bowel Preparation in Elderly Patients', 'orgStudyIdInfo': {'id': 'KY20170119-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'split-dose of Magnesium Sulfate solution', 'description': 'Those assigned to MSS group were instructed to take 30ml of 50% magnesium sulfate solution and then drink 600ml water on the evening before colonoscopy. 70ml of 50% MMS and then 1500ml water was taken at least 4 hours before procedure on the colonoscopy day.', 'interventionNames': ['Other: split-dose of Magnesium Sulfate solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'split-dose of PEG', 'description': 'Patients in PEG group were instructed to take first dose of 1.5L PEG on the evening before colonoscopy and take the second dose of 1.5L PEG at least 4 hours before the colonoscopy procedure on the morning.', 'interventionNames': ['Other: split-dose of PEG']}], 'interventions': [{'name': 'split-dose of Magnesium Sulfate solution', 'type': 'OTHER', 'description': 'purgative for bowel preparation', 'armGroupLabels': ['split-dose of Magnesium Sulfate solution']}, {'name': 'split-dose of PEG', 'type': 'OTHER', 'description': 'purgative for bowel preparation', 'armGroupLabels': ['split-dose of PEG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Endoscopic center, Xijing Hospital of Digestive Diseases', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '100853', 'city': 'Beijing', 'country': 'China', 'facility': 'Department of Gastroenterology, The Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital,', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, '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'}}}}