Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-03 @ 11:31 AM
Study NCT ID:
NCT03763266
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2018-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 858}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2018-11-10', 'studyFirstSubmitQcDate': '2018-12-03', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bowel preparation', 'timeFrame': 'During the colonoscopy', 'description': 'Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation.'}], 'secondaryOutcomes': [{'measure': 'Diet tolerance', 'timeFrame': 'It is reported before entering the endoscopy room. Regarding the 3 or 1 days on low fiber diet depending on which study group is the participant.', 'description': 'Using Likert scale. From 1 to 5, lower is better tolerance.'}, {'measure': 'Preparation tolerance', 'timeFrame': 'It is reported before entering the endoscopy room. Regarding the 3 or 1 day on bowel preparation depending on which study group is the participant.', 'description': 'Using Likert scale. From 1 to 5, lower is better tolerance.'}, {'measure': 'Adenoma detection rate', 'timeFrame': 'up to 2 weeks after colonoscopy depending on pathology department workload.', 'description': 'Proportion of colonoscopies with detection of colorectal cancer or adenoma excluding distal hyperplastic'}, {'measure': 'Endoscopic diagnosis', 'timeFrame': 'It is assessed during the colonoscopy and will be reported the same day.', 'description': 'Final endoscopic diagnosis. For example; normal, diverticulosis, polyps, colorectal cancer, etc.'}, {'measure': 'Cecum intubation rate', 'timeFrame': 'It will be calculated through study completion, approximately 1 year, for all the study period using all participants having the colonoscopy done', 'description': 'Cecum intubation will be assessed during each colonoscopy if the endoscope reaches the cecum.'}, {'measure': 'Intubation time', 'timeFrame': 'it is assessed from the start of the colonoscopy until cecum is reached (1 day)', 'description': 'time lapse from the start of the exploration until cecum is reached.'}, {'measure': 'Withdrawal time', 'timeFrame': 'it is assessed from at the beginning of the withdrawal of the colonoscope until the colonoscopy is finished. (procedure)', 'description': 'Time lapse between cecum withdrawal the end of the exploration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bowel preparation', 'low residue diet', 'colonoscopy'], 'conditions': ['Colonoscopy', 'Colon Adenoma', 'Colorectal Neoplasms', 'Inflammatory Bowel Diseases', 'Colon Disease']}, 'descriptionModule': {'briefSummary': 'Colonoscopy is the gold-standard for the evaluation of the colorectal mucosa. Colonoscopy quality indicators are the adenoma detection rate, the rate of cecal intubation and the bowel preparation.\n\nThe role of diet in preparing for colonoscopy is not fully established. Currently there is not enough evidence available to choice between 3 days of low residue diet versus 1 day.\n\nThe research hypothesis is that the low residue diet offers a non-inferior bowel preparation and an improved tolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants in the colorectal cancer screening program that give consent\n\nExclusion Criteria:\n\n* Contraindication for colonoscopy'}, 'identificationModule': {'nctId': 'NCT03763266', 'briefTitle': 'Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Parc Taulí Hospital Universitari'}, 'officialTitle': 'Low Residue Diet 3 Days Versus 1 Day as Preparation for Colonoscopy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2017308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 day low residue diet', 'description': 'Patients are instructed to complete a low residue diet exclusively one day prior the colonoscopy.', 'interventionNames': ['Other: 1 day low residue diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 days low residue diet', 'description': 'Patients are instructed to complete a low residue diet three days prior the colonoscopy.', 'interventionNames': ['Other: 3 day low residue diet']}], 'interventions': [{'name': '1 day low residue diet', 'type': 'OTHER', 'otherNames': ['low fiber diet'], 'description': 'Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.', 'armGroupLabels': ['1 day low residue diet']}, {'name': '3 day low residue diet', 'type': 'OTHER', 'otherNames': ['low fiber diet'], 'description': 'Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.', 'armGroupLabels': ['3 days low residue diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'overallOfficials': [{'name': 'Eva Martínez, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corporació Sanitaria Parc Taulí'}, {'name': 'Salvador Machlab, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corporació Sanitaria Parc Taulí'}, {'name': 'Rafel Campo, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corporació Sanitaria Parc Taulí'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc Taulí Hospital Universitari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Salvador Machlab', 'investigatorAffiliation': 'Parc Taulí Hospital Universitari'}}}}