Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT01025960
Status:
COMPLETED
Last Update Posted:
2012-03-27
First Post:
2009-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of Methods to Detect Polyps During Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D011127', 'term': 'Polyps'}], '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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 768}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-26', 'studyFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2009-12-02', 'lastUpdatePostDateStruct': {'date': '2012-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma detection rates for each method', 'timeFrame': 'within the first 30 days after colonoscopy'}], 'secondaryOutcomes': [{'measure': 'Comparison of procedure times for each method', 'timeFrame': '1 year'}, {'measure': 'Percentage of patients with at least one adenoma detected by each method', 'timeFrame': '1 year'}, {'measure': 'Comparison of percentage of adenomas classified as high risk for each method', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['colonoscopy', 'adenoma detection', 'polyps'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '25037727', 'type': 'DERIVED', 'citation': 'Sanaka MR, Parsi MA, Burke CA, Barnes D, Church J, Rizk M, Zein N, Joseph R, Thota PN, Lopez R, Kiran RP. Adenoma detection at colonoscopy by polypectomy in withdrawal only versus both insertion and withdrawal: a randomized controlled trial. Surg Endosc. 2015 Mar;29(3):692-9. doi: 10.1007/s00464-014-3723-3. Epub 2014 Jul 19.'}]}, 'descriptionModule': {'briefSummary': "Colorectal cancer (CRC) is the third most common cancer and second leading cause of cancer deaths in western countries. Colonoscopy is a preferred colorectal screening modality since it has both diagnostic and therapeutic capability. Detection and removal of polyps at colonoscopy decreases the incidence and mortality from colorectal cancer.\n\nTypical practice is to insert the colonoscope rapidly until it reaches the cecum (a pouch-like portion of the intestines, where the large bowel and the small bowel meet). The physician then withdraws the colonoscope slowly and looks for any polyps or abnormalities within the large bowel. The purpose of this study is to compare this standard practice to the approach whereby the physician examines the bowel as the scope is initially inserted AND as the colonoscope is withdrawn from patients' colons."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\n* Patients able to provide an informed consent\n* Patients undergoing colonoscopy\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients with Familial Adenomatous Polyposis Syndromes (FAP)\n* Patients with Hereditary Non-polyposis Colon Cancer Syndrome (HNPCC)\n* Patients who have undergone previous surgical resection of the colon\n* Patients who have been diagnosed with inflammatory bowel disease'}, 'identificationModule': {'nctId': 'NCT01025960', 'briefTitle': 'A Comparison of Methods to Detect Polyps During Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Comparison of Detection of Polyps During Both Insertion and Withdrawal Phases of Colonoscopy Versus the Standard Practice of Detection of Polyps During the Withdrawal Phase of Colonoscopy: A Prospective Quality Improvement Study', 'orgStudyIdInfo': {'id': '09-786'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard Inspection Colonoscopy', 'description': 'The colonoscope will be inserted rapidly to reach the cecum. Inspection of the large bowel will occur during the withdrawal of the colonoscope.', 'interventionNames': ['Procedure: Standard Inspection Colonoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dual Inspection Colonoscopy', 'description': 'The large bowel will be inspected for polyps during the insertion of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.', 'interventionNames': ['Procedure: Dual Inspection Colonoscopy']}], 'interventions': [{'name': 'Standard Inspection Colonoscopy', 'type': 'PROCEDURE', 'description': 'The large bowel will be inspected for polyps during the withdrawal of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.', 'armGroupLabels': ['Standard Inspection Colonoscopy']}, {'name': 'Dual Inspection Colonoscopy', 'type': 'PROCEDURE', 'description': 'The large bowel will be inspected for polyps during the insertion of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.', 'armGroupLabels': ['Dual Inspection Colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Madhusudhan Sanaka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}