Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-31 @ 2:32 AM
Study NCT ID:
NCT04605432
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2020-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FFI and PR Could Improve Bowel Cleansing.
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-29', 'studyFirstSubmitDate': '2020-10-22', 'studyFirstSubmitQcDate': '2020-10-27', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Bowel Preparation', 'timeFrame': '1 Day of colonoscopy', 'description': 'The BBPS is a validated scoring system with scores between 0 and 9, where 9 is the best score. The score comprises a sub score 0-3 for each colon segment: right, transverse and left colon.\n\nFor all participants, BBPS score will be used when colonscopy is withdrawing.'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': 'The day of colonoscopy and the day before', 'description': 'Including nausea, vomiting, abdominal pain and bloating,etc.'}, {'measure': 'cecal intubation rate', 'timeFrame': '1 Day of colonoscopy', 'description': 'The number of colonoscopy reaching the cecal area divided by the total number of colonoscopy'}, {'measure': 'polyp detection rate', 'timeFrame': '1 Day of colonoscopy', 'description': 'PDR was defined as the number of patients with at least one polyp divided by the total number of colonoscopy patients'}, {'measure': 'cecal intubation time', 'timeFrame': '1 Day of colonoscopy', 'description': 'Time to reach the cecal'}, {'measure': 'withdrawal time', 'timeFrame': '1 Day of colonoscopy', 'description': 'Time from withdrawal from the cecum to the end of colonoscopy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bowel preparation; face-to-face instruction; personalized intervention'], 'conditions': ['Bowel Preparation']}, 'descriptionModule': {'briefSummary': "background:The use of enhanced instruction can improve the efficiency of education for bowel preparation regimens. Researchers hypothesized that face-to-face instruction and personalized intervention for inpatient could improve successful bowel preparation rate and patient's compliance with regimens.\n\nMethods:This was an endoscopist-blind,randomized controlled trial. 320inpatients were randomized 1:1 in one of the two study groups. The intervention group received face-to-face instruction and personalized intervention for bowel preparation protocol, while control group received the standard bowel preparation protocol. Patients'demographics, bowel preparation quality, colonoscopy completion and attendance were recorded. Logistic regression was performed to identify predictors of bowel preparation failure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients undergoing colonoscopy.\n* patients older than 18 years.\n\nExclusion Criteria:\n\n* prior surgery of colorectal resection;\n* suspected colonic stricture or perforation;\n* incomplete or complete bowel obstruction;\n* use of prokinetic agents or purgatives within 7 days;\n* Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon;;\n* pregnancy or lactation;\n* Inability to prepare bowel;\n* unable to give informed consent.'}, 'identificationModule': {'nctId': 'NCT04605432', 'briefTitle': 'FFI and PR Could Improve Bowel Cleansing.', 'organization': {'class': 'OTHER', 'fullName': 'Ningbo No. 1 Hospital'}, 'officialTitle': 'Face-to-face Instructions and Personalized Bowel Cleansing Regimens for Inpatients Could Improve Bowel Preparation Quality.', 'orgStudyIdInfo': {'id': 'FFI-1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEG-FFI prep', 'description': 'On the day before colonoscopy, an experienced researcher would go to the ward to have a face-to-face conversation with the patient to know if patients have the risk factors for bowel preparation failure.\n\nThe bowel preparation regimens for patients with risk factors would be optimized. In addition to drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min, the patient also drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at 20:00- 21:00 hours on the day before the colonoscopy. Patients without risk factors drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min.\n\nPatients would received a booklet to explain the details of diet restriction, preparation method and the pictures of bowel preparation of results.The researcher would give a detailed oral explanation of the booklet.', 'interventionNames': ['Drug: PEG-FFI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PEG-nonFFI prep', 'description': 'Patients in the PEG-nonFFI group would only receive routine patient education on bowel preparation of colonoscopy, which was completed by ward nurse. all the patients drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min.', 'interventionNames': ['Drug: PEG-nonFFI']}], 'interventions': [{'name': 'PEG-FFI', 'type': 'DRUG', 'description': 'Patients with risk factor : on the day before the colonoscopy at 20:00- 21:00 hours, 60gPEG-4000 was mixed with 1L water; 4-6 h before colonoscopy, 120gPEG-4000 was mixed with 2L water.\n\nPatient without risk factor: 4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 3L water.\n\nEducation completed by experienced researcher.', 'armGroupLabels': ['PEG-FFI prep']}, {'name': 'PEG-nonFFI', 'type': 'DRUG', 'description': 'All patients on the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 3L water.\n\nEducation completed by ward nurse.', 'armGroupLabels': ['PEG-nonFFI prep']}]}, 'contactsLocationsModule': {'locations': [{'zip': '315000', 'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Ningbo No. 1 Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ningbo No. 1 Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}