Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-25 @ 7:15 PM
Study NCT ID:
NCT02819492
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2016-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Side Specific Withdrawal Times for Colonoscopy: Impact on Adenoma Detection in the Proximal and Distal Colon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000236', 'term': 'Adenoma'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Colon polyps'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-08', 'studyFirstSubmitDate': '2016-06-28', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma detection rate in the proximal colon', 'timeFrame': 'up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)', 'description': 'After obtaining the histopathological diagnosis of resected polyps (approximately 3 -6 days) it can be determined whether the resected polyp contained adenomatous histology or not.'}], 'secondaryOutcomes': [{'measure': 'Polyp detection rate', 'timeFrame': 'up to one day', 'description': 'a maximum of one day is expected for colonoscopy procedures'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adenoma', 'Colonoscopy', 'Withdrawal', 'Proximal', 'Observation Time'], 'conditions': ['Colon Adenoma']}, 'descriptionModule': {'briefSummary': 'Adenoma detection in the main goal of screening colonoscopy. In order to detect adenomas it is mandatory to spend a long enough time investigating the colonic mucosa. A minimum observation time of 6 minutes has been proposed as a quality criterion for screening colonoscopy. However, different locations of the colon (proximal, distal) may require specific observation time periods. The colon can be divided into a proximal (right) and distal (left) part. Until now, it is unclear whether observation time has a significant impact on adenoma detection in both parts of the colon. The aim of this study therefore is to conduct a trial in which side-specific observation times and adenoma detection rates are measured in order to investigate this correlation in particular for the right colon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving colonoscopy at the study site are eligible for participation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication for colonoscopy\n* age ≥ 40 years\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists class IV or higher\n* pregnant women\n* indication for colonoscopy: inflammatory bowel disease\n* indication for colonoscopy: polyposis syndrome\n* indication for colonoscopy: emergency colonoscopy e.g. acute bleeding\n* contraindication for polyp resection e.g. patients on warfarin'}, 'identificationModule': {'nctId': 'NCT02819492', 'acronym': 'SNOWCAT', 'briefTitle': 'Side Specific Withdrawal Times for Colonoscopy: Impact on Adenoma Detection in the Proximal and Distal Colon', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'orgStudyIdInfo': {'id': 'SNOWCAT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Routine colonoscopy Cohort', 'description': 'Patients receiving routine colonoscopy at the study site'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81677', 'city': 'Munich', 'country': 'Germany', 'facility': 'II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}