Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT03765216
Status:
UNKNOWN
Last Update Posted:
2018-12-05
First Post:
2018-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study
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': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned to group A or B. Participants of group A are given normal bowel preparation, while participants of group B are given personalized regimens according to a predictive model we have established.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-04', 'studyFirstSubmitDate': '2018-12-04', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adequate bowel preparation rates', 'timeFrame': '2 months', 'description': 'Adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)'}], 'secondaryOutcomes': [{'measure': 'Polyp detection rate', 'timeFrame': '2 months', 'description': 'Polyp detection rates between 2 groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bowel Preparation', 'Colonoscopy']}, 'descriptionModule': {'briefSummary': "About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics.", 'detailedDescription': 'Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole colon. Inadequate bowel preparation is the predominant threaten to the efficacy of colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel preparation. In order to improve adequate bowel preparation rate, it is desirable to prescribe personalized regimen according to patient characteristics. We intend to improve adequate bowel preparation rate by deploying tailored bowel preparation strategy. There are many predictive factors of inadequate bowel preparation such as obesity, constipation, abdominal surgery and so on. By recognizing these risk factors of the patients , we can prescribe the patients with higher dose of bowel cleansing regimen to improve bowel preparation quality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18 or older\n* patients undergoing colonoscopy\n\nExclusion Criteria:\n\n* patients with a history of colorectal surgery\n* patients with severe colonic stricture or obstructing tumor\n* patients with dysphagia\n* patients with compromised swallowing reflex or mental status\n* patients with significant gastroparesis or gastric outlet obstruction\n* patients with known or suspected bowel obstruction or perforation\n* patients with severe chronic renal failure (creatinine clearance\\<30 ml/min)\n* patients with severe chronic renal failure (creatinine clearance\\<30 ml/min)\n* patients with uncontrolled hypertension (systolic blood pressure\\>170 mm Hg, diastolic blood pressure\\>100 mm Hg)\n* patients with inflammatory bowel disease or megacolon\n* patients with dehydration\n* patients with dehydration\n* patients with pregnancy or lactation\n* patients hemodynamically unstable\n* patients unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT03765216', 'briefTitle': 'Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2018SDU-QILU-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: standard group', 'description': 'Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.', 'interventionNames': ['Drug: 2L Polyethylene Glycol (PEG)']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: tailored group', 'description': 'Participants are given personalized regimens for bowel preparation according to the the predictive model( a model which grades patients as low or high risk according to risk factors such as age, body mass index≧ 30 kg/m2, diabetes, constipation, pelvic surgery and tricyclic antidepressants usage).\n\nLow risk patients are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; High risk patients are given standard regimen: 4 L Polyethylene Glycol (PEG) regimen.', 'interventionNames': ['Drug: 2L Polyethylene Glycol (PEG)', 'Drug: 4L Polyethylene Glycol (PEG)']}], 'interventions': [{'name': '2L Polyethylene Glycol (PEG)', 'type': 'DRUG', 'otherNames': ['Standard'], 'description': 'Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen', 'armGroupLabels': ['Group A: standard group', 'Group B: tailored group']}, {'name': '4L Polyethylene Glycol (PEG)', 'type': 'DRUG', 'otherNames': ['High dose'], 'description': 'High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen', 'armGroupLabels': ['Group B: tailored group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': "Ji'nan", 'state': 'Shandong', 'country': 'China', 'facility': 'Department of Gastroenterology, Qilu Hospital, Shandong University'}], 'centralContacts': [{'name': 'Li Yanqing, PhD,MD', 'role': 'CONTACT', 'email': 'liyanqing@sdu.edu.cn', 'phone': '86-531-82169236'}], 'overallOfficials': [{'name': 'Li Yanqing, PhD,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital, Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The individual participant data of this trial will be shared when necessary'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President of Qilu Hospital', 'investigatorFullName': 'Yanqing Li', 'investigatorAffiliation': 'Shandong University'}}}}