Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-02-10 @ 5:53 AM
Study NCT ID:
NCT01675934
Status:
WITHDRAWN
Last Update Posted:
2016-01-08
First Post:
2012-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI has left institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-06', 'studyFirstSubmitDate': '2012-08-28', 'studyFirstSubmitQcDate': '2012-08-28', 'lastUpdatePostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of cases in which right-sided retroflexion is successful with the adult and pediatric colonoscopes.', 'timeFrame': 'After 50% and 100% of patient enrollment is complete.'}], 'secondaryOutcomes': [{'measure': 'Adenoma detection rate in forward and retroflexed views.', 'timeFrame': 'After 50% and 100% of patient enrollment is complete.'}, {'measure': 'Reasons for failure of retroflexion.', 'timeFrame': 'After 50% and 100% of patient enrollment is complete.', 'description': 'This will be assessed as a yes/no variable. In addition, the specific reasons that the endoscopist could not retroflex the colonoscope in the right colon will assessed, such as the colonoscope not being able to be advanced to the cecum, small diameter of the right colon, too much resistance encountered when attempting retroflexion that the endoscopist does not feel comfortable with, etc.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colonic Neoplasms']}, 'descriptionModule': {'briefSummary': 'Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in the proximal colon compared to the distal colon. Possible reasons for this include bowel preparation often being worse in the proximal colon as well as flat depressed lesions being more common in the proximal colon.\n\nRetroflexion is commonly regarded as standard practice in the rectum, but retroflexion in the proximal colon is not currently routinely performed due to concerns of perforation and possibly because of the increased time required.\n\nProximal colon retroflexion has been shown to be safe and effective without any complications, but data regarding ability to retroflex with certain types of colonoscopes is limited. Endoscopists interchangeably use standard adult colonoscopes or pediatric colonoscopes. Studies have not been performed to comparatively evaluate the success rates of standard adult and pediatric colonoscopes and whether either type of instrument confers a greater polyp detection rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients over the age 18 undergoing screening or surveillance colonoscopy\n\nExclusion Criteria:\n\n* Age less than 18\n* Pregnant\n* History of ulcerative colitis or Crohn's disease\n* History of polyposis syndromes\n* History of colon resection\n* Colonoscopy being performed for diagnostic purposes (ie. bleeding, abdominal pain, alternating bowel habits)"}, 'identificationModule': {'nctId': 'NCT01675934', 'briefTitle': 'Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes', 'orgStudyIdInfo': {'id': 'PRO00017208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adult colonoscope', 'description': 'Use of the adult colonoscope.', 'interventionNames': ['Procedure: Retroflexion with the adult colonoscope.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pediatric colonoscope', 'description': 'Use of the pediatric colonoscope.', 'interventionNames': ['Procedure: Retroflexion with the pediatric colonoscope.']}], 'interventions': [{'name': 'Retroflexion with the adult colonoscope.', 'type': 'PROCEDURE', 'armGroupLabels': ['Adult colonoscope']}, {'name': 'Retroflexion with the pediatric colonoscope.', 'type': 'PROCEDURE', 'armGroupLabels': ['Pediatric colonoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert Surgery Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Young Oh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}