Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-03-01 @ 8:56 PM
Study NCT ID:
NCT01476735
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2011-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual Approach for Bowel Preparation Before Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 266}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-05', 'studyFirstSubmitDate': '2011-11-17', 'studyFirstSubmitQcDate': '2011-11-21', 'lastUpdatePostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the index of preparation quality for the whole colon', 'timeFrame': '24 hours', 'description': 'the percentage of patients with adequate bowel preparation; adequate preparation is defined as excellent, good and fair, inadequate is defined as poor or unprepared colon according to the Ottawa bowel preparation scale'}], 'secondaryOutcomes': [{'measure': 'compliance safety', 'timeFrame': '24 hours', 'description': 'number of patients with completion of preparation number of patients with side effects of preparation in each group'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Split-dose Bowel Preparation', 'Polyethylene Glycol Solution', 'Risk Factors Inadequate Preparation']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, single-blind study designed to evaluate the influence of individual approach on bowel preparation quality for colonoscopy. The investigators compare split-dose polyethylene glycol solution (PEG, Fortrans, Beaufour Ipsen) to modified split-dose PEG regarding predictors of inadequate preparation for colonoscopy.', 'detailedDescription': "Up to 22% of patients are not good prepared for colonoscopy and it is caused of aborted procedures and increased costs. There are identified predictors of inadequate bowel preparation before colonoscopy, but we still don't know if an individual approach improve the quality of preparation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women more than 18 years of age undergoing colonoscopy for routine clinical indications\n* provided written informed consent\n\nExclusion Criteria:\n\n* lack of written informed consent or inability to provide informed consent or refusal to consent to the study\n* pregnancy and breast feeding\n* known allergy to PEG or bisakodyl\n* presence of serious conditions such as severe cadiac, renal or metabolic diseases, major psychiatric illness or end-stage cancer disease requiring taking narcotic drugs\n* colonoscopy performed under conscious sedation'}, 'identificationModule': {'nctId': 'NCT01476735', 'briefTitle': 'Individual Approach for Bowel Preparation Before Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Maria Sklodowska-Curie National Research Institute of Oncology'}, 'officialTitle': 'A Prospective, Randomized, Single-blind Study Evaluating Individual Approach on Bowel Preparation Quality for Colonoscopy', 'orgStudyIdInfo': {'id': 'Individual bowel preparation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'split-dose polyethylene glycol solution', 'description': 'first dose (1,5 l) of polyethylene glycol solution taken at 6-7.00 in the evening before colonoscopy, second dose (1,5 l) taken at 5.30-6.00 in the morning of a day of colonoscopy; additional bisacodyl taken at 12.00 at the day before colonoscopy', 'interventionNames': ['Other: individual preparation for colonoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Individual preparation for colonoscopy', 'interventionNames': ['Other: individual preparation for colonoscopy']}], 'interventions': [{'name': 'individual preparation for colonoscopy', 'type': 'OTHER', 'description': 'The volume of polyethylene glycol solution depends on risk factors presented in each patient. Time of administration of second dose will be confirmed according to the time of colonoscopy. In case of constipation an enema before colonoscopy will be administered. All patients will give educational booklet of preparation before colonoscopy', 'armGroupLabels': ['Individual preparation for colonoscopy', 'split-dose polyethylene glycol solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Jaroslaw Regula, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland'}, {'name': 'Michal F. Kaminski, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland'}, {'name': 'Dorota Wretowska, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Sklodowska-Curie National Research Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}