Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT01458093
Status:
COMPLETED
Last Update Posted:
2011-10-24
First Post:
2011-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Large Overuse of Post-polypectomy Surveillance Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7081}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-20', 'studyFirstSubmitDate': '2011-10-18', 'studyFirstSubmitQcDate': '2011-10-20', 'lastUpdatePostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to post-polypectomy surveillance guidelines', 'timeFrame': 'up to one year', 'description': 'Time interval between index and surveillance colonoscopies for patients undergoing post-polypectomy surveillance was calculated and compared to that suggested by the guidelines according to endoscopic findings at previous examination. For each patiens, surveillance time interval was regarded as correct if coherent with the recommended interval +/- 6 months, thus allowing to calculate the proportion of correct prescriptions'}], 'secondaryOutcomes': [{'measure': 'Factors associated to surveillance appropriateness', 'timeFrame': 'up to one year', 'description': 'The presence of factors associated to appropriate surveillance prescriptions was investigated by multivariate analysis (odds ratio and 95% confidence interval for each factor)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colonic Polyps', 'Surveillance', 'Colonoscopy']}, 'referencesModule': {'references': [{'pmid': '22627070', 'type': 'DERIVED', 'citation': 'Radaelli F, Paggi S, Bortoli A, De Pretis G; Italian Association of Hospital Gastroenterologists (AIGO). Overutilization of post-polypectomy surveillance colonoscopy in clinical practice: a prospective, multicentre study. Dig Liver Dis. 2012 Sep;44(9):748-53. doi: 10.1016/j.dld.2012.04.015. Epub 2012 May 22.'}]}, 'descriptionModule': {'briefSummary': 'In colorectal cancer screening era a huge burden of medical resources has been applied to surveillance. Although the adherence to post-polipectomy recommendations is a advocated as a mainstay for quality assurance colonoscopy programs, prospective data on appropriateness of surveillance are lacking.\n\nThe aim of present study was to evaluate the percentage of subjects in which timing of surveillance colonoscopy in practice agrees with that recommended by guidelines and to identify factors associated to the appropriateness of surveillance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients referred to one out of 29 endoscopy units in Italy to undergo colonoscopy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consecutive colonoscopy outpatients\n* adults (18-80 yrs)\n\nExclusion Criteria:\n\n* Subjects with missing data on polyp findings at previous colonoscopy (number, endoscopic or histological features)\n* Subjects with unsatisfactory quality standards of previous examination (no cecal intubation, inadequate bowel preparation, incomplete polyp resection)\n* patients with a medical history of inflammatory bowel disease, inherited or other polyposis syndrome and colorectal cancer.'}, 'identificationModule': {'nctId': 'NCT01458093', 'briefTitle': 'Large Overuse of Post-polypectomy Surveillance Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Valduce Hospital'}, 'officialTitle': 'Large Overuse of Post-polypectomy Surveillance Colonoscopy: a Prospective Nation-wide Study', 'orgStudyIdInfo': {'id': 'SURV_2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colonoscopy patients', 'description': 'Consecutive colonoscopy outpatients referred to one of 29 endoscopy units in Italy', 'interventionNames': ['Other: colonoscopy']}], 'interventions': [{'name': 'colonoscopy', 'type': 'OTHER', 'description': 'evaluation of surveillance timing adequacy as compared to the guidelines', 'armGroupLabels': ['Colonoscopy patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22100', 'city': 'Como', 'country': 'Italy', 'facility': 'Valduce Hospital', 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valduce Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Franco Radaelli', 'investigatorAffiliation': 'Valduce Hospital'}}}}