Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-02-11 @ 8:35 PM
Study NCT ID:
NCT03041532
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2017-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], '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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 692}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-16', 'studyFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2017-02-01', 'lastUpdatePostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proximal retroflexion improve adenoma detection rate in colorectal cancer screening', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Determine whether to perform retroflexion proximal improves adenoma detection rate in the right colon versus forward vision in population screening colorectal cancer with medium risk with immune blood test positive stool'}], 'secondaryOutcomes': [{'measure': 'Second look for right colon improve adenoma detection rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Determine if a second look: retroflexion proximal or forward view improve adenoma detection rate'}, {'measure': 'Rate of retroflexion related adverse events', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Rate of retroflexion proximal adverse events with a pediatric colonoscopy', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Pre-procedure factors', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'To analyze pre-procedure factors that may influence the prevalence of precursor lesions in the colon: age, sex, race, alcohol, smoking habit and the value of SOH, in which more detailed explorations should be performed using proximal retroflexion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['retroflexion proximal', 'colorectal cancer screening programme', 'adenoma detection rate', 'right colon'], 'conditions': ['Colorectal Neoplasms', 'Adenoma Detection Rate']}, 'descriptionModule': {'briefSummary': 'Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the Western world. The decrease in incidence and mortality by CRC in the population undergoing screening has been observed. Colonoscopy is the recommended method for detecting tumors in early stages, as well as identifying and resecting adenomatous polyps, which are the precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease incidence and mortality by CRC and avoid interval cancer. The literature shows that colonoscopy does not prevent right colon lesions in the same way as the left colon lesions, with most of the interval cancers located in the right colon. Studies published so far show an increase in the adenomas detection rate (ADT) in the right colon in the second visualization of this segment and an increase between 2 and 10% if this second examination is performed with the proximal retroflexion maneuver.Retroflexion is a safe maneuver in expert endoscopists. The aim of our study is to evaluate the ADT in the right colon by means of a second visualization by performing proximal retroflexion or second frontal visualization at random in the CCR screening population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects participating in the Colorectal cancer Screening program with faecal immunological test \\> 100ng / ml.\n* Ages between 50-69 years.\n* Adequate preparation according to the Boston scale: in right colon (score\\> 2 in this section)\n* Informed consent.\n\nExclusion Criteria:\n\n* Refusal to give informed consent.\n* Subjects with elevated colorectal cancer risk due to family history or inherited diseases of polyposis or inflammatory bowel disease\n* Symptomatic subjects.\n* Diverticulitis, inflammatory bowel disease or colonic stenosis during the exploration\n* Inadequate preparation according to Boston cleanliness scale (score ≤ 2 in right colon)'}, 'identificationModule': {'nctId': 'NCT03041532', 'briefTitle': 'Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme', 'organization': {'class': 'OTHER', 'fullName': 'Hospital del Rio Hortega'}, 'officialTitle': 'Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme: Randomized Trial', 'orgStudyIdInfo': {'id': 'CEIC 62/16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'proximal retroflexion', 'description': 'Procedure: The endoscopy explore right colon with frontal view and a second look with proximal retroflexion', 'interventionNames': ['Procedure: Proximal retroflexion', 'Procedure: Frontal view']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'frontal view of right colon', 'description': 'Procedure: The endoscopy explore right colon with frontal view and frontal view', 'interventionNames': ['Procedure: Frontal view']}], 'interventions': [{'name': 'Proximal retroflexion', 'type': 'PROCEDURE', 'description': 'The investigator explore twice right colon, first front view and second forward viewing or proximal retroflexion depends on randomization', 'armGroupLabels': ['proximal retroflexion']}, {'name': 'Frontal view', 'type': 'PROCEDURE', 'description': 'The investigator explore twice right colon with frontal viewing', 'armGroupLabels': ['frontal view of right colon', 'proximal retroflexion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47012', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Universitario Rio Hortega', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Mª Henar Núñez Rodriguez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital del Rio Hortega Valladolid, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital del Rio Hortega', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator: Dra Mª Henar Núñez Rodriguez', 'investigatorFullName': 'Mª Henar Núñez Rodriguez', 'investigatorAffiliation': 'Hospital del Rio Hortega'}}}}