Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT05107505
Status:
UNKNOWN
Last Update Posted:
2022-03-03
First Post:
2021-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of The Factors Affecting Bowel Preparation Adequacy for Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-07-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-15', 'studyFirstSubmitDate': '2021-10-26', 'studyFirstSubmitQcDate': '2021-10-26', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improper bowel preparation', 'timeFrame': '01/07/2021-30/06/2022', 'description': 'Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.'}], 'secondaryOutcomes': [{'measure': 'quality of preparation for colonoscopy', 'timeFrame': '01/07/2021-30/06/2022', 'description': 'Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bowel Preparation', 'Preparation for Colonoscopy']}, 'referencesModule': {'references': [{'pmid': '19136102', 'type': 'BACKGROUND', 'citation': 'Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.'}, {'pmid': '23335011', 'type': 'BACKGROUND', 'citation': 'Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.'}, {'pmid': '32377915', 'type': 'BACKGROUND', 'citation': 'Millien VO, Mansour NM. Bowel Preparation for Colonoscopy in 2020: A Look at the Past, Present, and Future. Curr Gastroenterol Rep. 2020 May 6;22(6):28. doi: 10.1007/s11894-020-00764-4.'}]}, 'descriptionModule': {'briefSummary': 'A prospective observational study in order to:\n\n1. st: Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.\n2. nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.', 'detailedDescription': 'Unsuccessful preparation for lower gastrointestinal endoscopy is to date the main obstacle to a comprehensive examination and the main reason for its recurrence. It is also directly related to its diagnostic value.\n\nThe literature shows that the diet prior to colonoscopy, the time of assumption of the preparation and certain epidemiological and clinical characteristics of the patient can affect the outcome of the intestinal preparation for colonoscopy.\n\nThis seems that adequasy of colonoscopy affects a number of qualitative indicators of lower gastrointestinal endoscopy, such as the duration, the catheterization of the fundus of the cecum and the number of polyps found.\n\nThis is a prospective observational study in order to:\n\n1. st: Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.\n2. nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.\n\nWith starting date:01/07/2021 and expiration date:30/06/2022 (duration: 12 months). All patients who come to the Gastroenterology Department of Alexandra Hospital for endoscopy of the lower digestive tract are eligible for the research protocol. Patients younger than 18 years old or patients who refuse to participate are excluded.\n\nThe study has 3 phases. Phase 0 entails the completion of a questionnaire that will include epidemiological, clinical and preparation-related data in all patients who undergoing colonoscopy at the Endoscopy Department. Phase I incorporates Completion of data related to the time of the examination, the result of the preparation (Boston Bowel Preparation Scale) as well as the findings of the endoscopic examination and phase II includes the statistical analysis of the data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1000 adult patients undergoing colonoscopy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients undergoing colonoscopy:\n\n* Age \\> 18 years\n* Have been prepared for lower gastrointestinal endoscopy\n* Have agreed to participate in the study\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Non-acceptance of participation in the study'}, 'identificationModule': {'nctId': 'NCT05107505', 'briefTitle': 'Evaluation of The Factors Affecting Bowel Preparation Adequacy for Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Alexandra Hospital, Athens, Greece'}, 'officialTitle': 'Evaluation of The Factors Affecting Bowel Preparation Adequacy for Colonoscopy', 'orgStudyIdInfo': {'id': 'Alexandra Bowel Preparation'}}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'SPYRIDON MICHOPOULOS, DIRECTOR', 'role': 'CONTACT', 'email': 'michosp5@gmail.com', 'phone': '+302103381387'}], 'facility': 'Alexandra General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Spyridon Michopoulos, MD', 'role': 'CONTACT', 'email': 'michosp5@gmail.com', 'phone': '00302103381387'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandra Hospital, Athens, Greece', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Of The Gastroenterology Departement', 'investigatorFullName': 'SPYRIDON MICHOPOULOS', 'investigatorAffiliation': 'Alexandra Hospital, Athens, Greece'}}}}