Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 7:30 AM
Study NCT ID:
NCT05651893
Status:
UNKNOWN
Last Update Posted:
2023-04-06
First Post:
2022-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Second Forward-view Examination of Left Colon for Adenoma Detection During Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1516}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-05', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2022-12-07', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left colon adenoma detection rate (LCADR)', 'timeFrame': '60 minutes', 'description': 'LCADR is the number of patients with at least one adenoma in the left colon, divided by the total number of patients.'}], 'secondaryOutcomes': [{'measure': 'adenoma detection rate(ADR)', 'timeFrame': '60 minutes', 'description': 'ADR is the number of patients with at least one adenoma, divided by the total number of patients.'}, {'measure': 'left colon adenomas per colonoscopy (LCAPC)', 'timeFrame': '60 minutes', 'description': 'LCAPC was calculated as the number of adenomas detected during in left colon colonoscopy withdraw divided by the number of colonoscopies.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adenoma detection rate', 'colonoscopy'], 'conditions': ['Colon Adenoma']}, 'referencesModule': {'references': [{'pmid': '33220526', 'type': 'BACKGROUND', 'citation': 'Zhao S, Yang X, Wang S, Meng Q, Wang R, Bo L, Chang X, Pan P, Xia T, Yang F, Yao J, Zheng J, Sheng J, Zhao X, Tang S, Wang Y, Wang Y, Gong A, Chen W, Shen J, Zhu X, Wang S, Yan C, Yang Y, Zhu Y, Ma RJ, Wang R, Ma Y, Li Z, Bai Y. Impact of 9-Minute Withdrawal Time on the Adenoma Detection Rate: A Multicenter Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e168-e181. doi: 10.1016/j.cgh.2020.11.019. Epub 2020 Nov 19.'}, {'pmid': '30738046', 'type': 'BACKGROUND', 'citation': 'Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.'}]}, 'descriptionModule': {'briefSummary': 'The incidence of colorectal cancer in China is increasing year by year. Studies have shown that colorectal cancer is more common in the left colon，especially in the China. Our previous study also showed a higher rate of missed adenoma in the left colon than the right colon during colonoscopy. Additionally, prolonging withdrawal time could only improve the ADR of right colon, but had limited effect on the ADR of left colon in our previous research. Our aim is to evaluate the effect of a second forward view examination of the left colon on the detection of adenoma detection during colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients whose age are between 40-75, or aged 76-85 depending on his condition\n* Patients who have indications for screening\n* Patients who have signed inform consent form.\n\nExclusion Criteria:\n\n* Patients who have undergone colonic resection\n* Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination\n* Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy\n* Patients with inflammatory bowel diseases\n* Patients with a history of abdominal surgery, or highly suspected or confirmed colorectal cancers by radiographic and laboratory tests Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).\n* Patients with pregnancy, severe chronic cardiopulmonary and renal disease.\n* Patients with failed cecal intubation\n* Patients with poor BPQ that necessitated a second bowel preparation\n* Patients with therapeutic colonoscopy for existing lesions\n* Patients refusing to participate or to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05651893', 'briefTitle': 'Efficacy of Second Forward-view Examination of Left Colon for Adenoma Detection During Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Efficacy of Second Forward-view Examination of Left Colon for Adenoma Detection During Colonoscopy: a Multicenter, Prospective, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SFW2022-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Second forward view examination group', 'description': 'After successful intubation of the cecum, the colonoscope is withdrawn to the splenic curvature with the colonic mucosa carefully inspected. Then the left colon, including the splenic curvature to the anus, is examined twice in the forward view.', 'interventionNames': ['Behavioral: re-examination']}, {'type': 'EXPERIMENTAL', 'label': 'Extended withdrawal time group', 'description': 'After successful intubation of the cecum, the colonoscope is withdrawn to the splenic curvature with the colonic mucosa carefully inspected. The colonoscope was withdrawn to the anus directly with withdrawal time extended to the double routine withdrawal time of the left colon.', 'interventionNames': ['Behavioral: extended withdraw time']}], 'interventions': [{'name': 're-examination', 'type': 'BEHAVIORAL', 'description': 'During colonoscopy, the left colon was examined a second time in the forward view.', 'armGroupLabels': ['Second forward view examination group']}, {'name': 'extended withdraw time', 'type': 'BEHAVIORAL', 'description': 'During colonoscopy, the left colon was examined with double basic withdrawal time in the forward view.', 'armGroupLabels': ['Extended withdrawal time group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Bai, MD', 'role': 'CONTACT', 'email': 'baiyu1998@hotmail.com', 'phone': '86-021-81873241'}, {'name': 'zhaoshen Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Changhai Hospital, Second Military Medical University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhaoshen Li, MD', 'role': 'CONTACT', 'email': 'li.zhaoshen@hotmail.com', 'phone': '86-021-31161365'}, {'name': 'Yu Bai, MD', 'role': 'CONTACT', 'email': 'baiyu1998@hotmail.com', 'phone': '86-021-31161335'}], 'overallOfficials': [{'name': 'Zhaoshen Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'No.85 Hospital, Changning, Shanghai, China', 'class': 'OTHER'}, {'name': "Shanxi Provincial People's Hospital", 'class': 'OTHER_GOV'}, {'name': 'The General Hospital of Eastern Theater Command', 'class': 'OTHER'}, {'name': 'The Sixth Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Kunshan Hospital of Traditional Chinese Medicine', 'class': 'UNKNOWN'}, {'name': 'Ningjin County Hospital', 'class': 'UNKNOWN'}, {'name': "Qinghai People's Hospital", 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Yangtze University', 'class': 'OTHER'}, {'name': 'Qujing NO.1 Hospital', 'class': 'UNKNOWN'}, {'name': "Jiangxi Provincial People's Hopital", 'class': 'OTHER'}, {'name': 'Yueyang Central Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': "The First People's Hospital of Changde City", 'class': 'OTHER'}, {'name': 'Xuzhou Central Hospital', 'class': 'OTHER'}, {'name': 'Wenzhou Central Hospital', 'class': 'OTHER'}, {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': "Jiangsu Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator', 'investigatorFullName': 'Zhaoshen Li', 'investigatorAffiliation': 'Changhai Hospital'}}}}