Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-11 @ 2:47 AM
Study NCT ID:
NCT01610856
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2012-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Versus Split Dose Polyethylene Glycol-based Colonic Lavage for Colonoscopy
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']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-01', 'studyFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2012-06-01', 'lastUpdatePostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Ottawa Bowel Preparation Score', 'timeFrame': 'Measured at time of Colonoscopy', 'description': 'A validated scale. Each of the right, mid and rectosigmoid colon is rated on a 5-point scale (0-4). In addition, a complete 3-point rating for overall colonic fluid is assessed resulting in an overall score range of 0 to 14. An excellent preparation with little fluid would score 0 to 1; a good preparation, 2 to 4; while scores higher than 4 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11 to 14, depending on the amount of colonic fluid.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bowel preparation', 'bowel purgative', 'bowel cleansing', 'colonoscopy'], 'conditions': ['Colonoscopy Preparation']}, 'referencesModule': {'references': [{'pmid': '27446836', 'type': 'DERIVED', 'citation': 'Mohamed R, Hilsden RJ, Dube C, Rostom A. Split-Dose Polyethylene Glycol Is Superior to Single Dose for Colonoscopy Preparation: Results of a Randomized Controlled Trial. Can J Gastroenterol Hepatol. 2016;2016:3181459. doi: 10.1155/2016/3181459. Epub 2016 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'Proper bowel cleansing prior is an essential requirement for the conduct of colonoscopy. However, due to the nature of cleansing process, the ideal bowel cleansing preparation remains elusive.\n\nThe objective of this study is to compare the efficacy, safety and tolerability of oral polyethylene glycol lavage given either as a single dose or split dose. The study will be a randomized controlled single blind two group study. The primary study outcomes will be the previously validated Ottawa bowel preparation score.', 'detailedDescription': 'All patients between the age of 50 and 75 years referred to the Forzani \\& MacPhail Colorectal Cancer Screening Centre in Calgary, Alberta, Canada for colonoscopy will be considered for inclusion. During pre-assessments at the clinic, patients will be asked to participate in the study by a nurse clinician. If they agree - final consent will be obtained by a gastroenterologist along with consent for the colonoscopy. Those not interested in participating will simply receive their physicians standard bowel preparation protocol. There will be no coercion of any sort.\n\nPatients with acute coronary syndrome, congestive heart failure, unstable angina, known or suspected renal failure, ascites, megacolon, known or suspected bowel obstruction, or other comorbidities that may prevent colonoscopy will be excluded. Patients will also be excluded if they previously had partial or subtotal colectomy or if the colonoscopy is warranted for the evaluation of diarrhea.\n\nEnrollment of participants will be performed with block randomizations of 8 stratified by AM versus PM procedure time using a computer-generated table, with allocation concealment maintained through the use of consecutively numbered sealed envelopes. Colonoscopists and investigators will be blinded to allocation groups. Patients will be allocated to one of two groups: (1) 4L PEG day prior to procedure; (2) 4L of PEG split in two 2L doses\n\nA study assistant will assign patients to their group and instruct them on the proper use of their assigned bowel preparation method. Patients will be given a tolerability questionnaire, that was modified from a previously reported questionnaire, to be completed once their bowel preparation is finished and before coming to the hospital for the colonoscopy. Patient concerns or questions regarding the preparation will be directed toward the assistant as opposed to their gastroenterologist, so as to avoid unblinding the gastroenterologist.\n\nOutcomes\n\nThe previously validated Ottawa bowel preparation scale80 will be used to assess the quality of bowel cleanliness. Each of the right, mid and rectosigmoid colon is rated on a 5-point scale (0-4). In addition, a complete 3-point rating for overall colonic fluid is assessed resulting in an overall score range of 0 to 14. An excellent preparation with little fluid would score 0 to 1; a good preparation, 2 to 4; while scores higher than 4 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11 to 14, depending on the amount of colonic fluid.\n\nColonoscopy will be performed in a standard fashion and endoscopists will rate the bowel-preparation quality during the procedure and record the result on a separate standardized form.\n\nSecondary outcomes will include a previously validated tolerability questionnaire and patient and investigator reported adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients between the age of 50 and 75 years referred to the Forzani \\& MacPhail Colorectal Cancer Screening Centre in Calgary, Alberta, Canada for colonoscopy will be considered for inclusion.\n\nExclusion Criteria:\n\n* patients with acute coronary syndrome,\n* congestive heart failure,\n* unstable angina,\n* known or suspected renal failure,\n* ascites,\n* megacolon,\n* known or suspected bowel obstruction, or\n* other comorbidities that may prevent colonoscopy will be excluded. Patients will also be excluded if they previously had partial or subtotal colectomy or if the colonoscopy is warranted for the evaluation of diarrhea.'}, 'identificationModule': {'nctId': 'NCT01610856', 'briefTitle': 'Single Dose Versus Split Dose Polyethylene Glycol-based Colonic Lavage for Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'A Randomized Prospective Trial Comparing Single Dose Polyethylene Glycol-based Lavage Versus Split Dose Polyethylene Glycol-based Lavage in the Preparation of Patients Undergoing Colonoscopy', 'orgStudyIdInfo': {'id': '21972'}, 'secondaryIdInfos': [{'id': 'Ethics ID 21972', 'type': 'OTHER', 'domain': 'University of Calgary Ethics ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEG - 4 L', 'description': '4 Litres PEG bowel preparation given the day prior to colonoscopy with a clear fluid diet', 'interventionNames': ['Drug: Polyethylene Glycol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Split Dose PEG', 'description': '4 Litres of Colyte given as two split doses of 2L each either the day before colonoscopy 8 hours apart in the case of an AM colonoscopy or in the case of an afternoon colonoscopy given 5PM the day before and 6:00AM the day of the colonoscopy', 'interventionNames': ['Drug: polyethylene glycol']}], 'interventions': [{'name': 'Polyethylene Glycol', 'type': 'DRUG', 'otherNames': ['co-lyte', 'Go-lyte', 'PEG'], 'description': '4 Litres of polyethylene glycol bowel preparation solution', 'armGroupLabels': ['PEG - 4 L']}, {'name': 'polyethylene glycol', 'type': 'DRUG', 'otherNames': ['PEG', 'Co-lyte', 'Go-lyte'], 'description': 'Polyethylene glycol 4L given in two split doses of 2L each', 'armGroupLabels': ['Split Dose PEG']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Forzani & MacPhail Colon Cancer Screening Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Alaa Rostom, MD MSc FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD MSc FRCPC', 'investigatorFullName': 'Alaa Rostom', 'investigatorAffiliation': 'University of Calgary'}}}}