Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-08 @ 5:44 AM
Study NCT ID:
NCT01496560
Status:
WITHDRAWN
Last Update Posted:
2015-11-17
First Post:
2011-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Prospective Study for Determination of Predictive Measures for Pain During Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'study terminated due toTechnical issue pre -recruiting', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-16', 'studyFirstSubmitDate': '2011-12-19', 'studyFirstSubmitQcDate': '2011-12-20', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-endoscopic Rectal balloon volumes', 'timeFrame': '1 year', 'description': 'Volume for first sensation, desire to deficate and maximal tolerance volume'}], 'secondaryOutcomes': [{'measure': 'Demographic data', 'timeFrame': '1 year', 'description': 'Demographic data related to excessive pain'}, {'measure': 'Pre-endocopic levels of anxiety', 'timeFrame': '1 year', 'description': 'Relation of Pre-endoscopic levels of anxiety to pain during colonoscopy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colonoscopy', 'pain', 'rectal balloon'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '17625440', 'type': 'BACKGROUND', 'citation': 'Park DI, Kim HJ, Park JH, Cho YK, Sohn CI, Jeon WK, Kim BI, Ryu SH, Sung IK. Factors affecting abdominal pain during colonoscopy. Eur J Gastroenterol Hepatol. 2007 Aug;19(8):695-9. doi: 10.1097/01.meg.0000219097.32811.24.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine what precolonoscopic measures can be correlated to pain during colonoscopy', 'detailedDescription': 'The aim of the work is to determine prdictive pre-endoscopic factors for pain during colonoscpy. These factors may be demographic, antrophometric, socio-ecomomic, related to previous medical staus or to anxiety levels.\n\nWe will try to find an objective parameter for prdiction of pain during colonoscopy, so pre-procedural intervantion will be applied in order to reduce the pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing screening colonoscopy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-70\n* screening colonoscopy\n\nExclusion Criteria:\n\n* Failed prior colonoscopy\n* pain as a main referral indication\n* complications during previous exam\n* Inpatients\n* Excision of more than 3 polyps\n* Diagnosis ofCancer, IBD\n* Incomplete exam'}, 'identificationModule': {'nctId': 'NCT01496560', 'briefTitle': 'Open Prospective Study for Determination of Predictive Measures for Pain During Colonoscopy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Comparison of Procedural Sequence in Same Day Consecutive Bidirectional Endoscopy Using Moderate Sedation: A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'Sheba-11-8679-DC-CTIL'}}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba medical center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'Dan Carter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gastroenterologist', 'investigatorFullName': 'Dr. Dan Carter, Gastroenterologist', 'investigatorAffiliation': 'Sheba Medical Center'}}}}