Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-01 @ 5:32 AM
Study NCT ID:
NCT03802006
Status:
UNKNOWN
Last Update Posted:
2019-01-14
First Post:
2019-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Assessment of Gastric Contents in Fasted Surgical Patients With Previous Subtotal Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'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': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-09', 'studyFirstSubmitDate': '2019-01-03', 'studyFirstSubmitQcDate': '2019-01-09', 'lastUpdatePostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of full cross section image', 'timeFrame': 'Before the induction of anesthesia', 'description': 'The gastric remnant body is assessed by ultrasound and the incidence of cross sectional image visualized fully is evaluated'}], 'secondaryOutcomes': [{'measure': 'Type of gastric content assessed by gastric ultrasound', 'timeFrame': 'Before the induction of anesthesia', 'description': 'The type of gastric content is assessed by gastric ultrasound; solid, fluid, empty'}, {'measure': 'Cross section area of stomach body assessed by gastric ultrasound', 'timeFrame': 'Before the induction of anesthesia', 'description': 'Cross section area is assessed by gastric ultrasound in the supine and right lateral positions'}, {'measure': 'Incidence of full stomach', 'timeFrame': 'Before the induction of anesthesia', 'description': 'It is determined if the contents is solid or the amount of fluid is large.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroparesis']}, 'descriptionModule': {'briefSummary': 'Investigators assess the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy.', 'detailedDescription': 'Investigators evaluate the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy, quantitatively and qualitatively. The frequency of visualization fully will be also analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will conduct a study targeting the patients with previous subtotal gastectomy among the patients fasted for an operation under general, spinal or MAC anesthesia, except people with other anatomical abnormality or mass of stomach except gastrectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The preoperative fasted patients with previous subtotal gastrectomy\n\nExclusion Criteria:\n\n* Other anatomical abnormality or mass of stomach except gastrectomy'}, 'identificationModule': {'nctId': 'NCT03802006', 'briefTitle': 'Ultrasound Assessment of Gastric Contents in Fasted Surgical Patients With Previous Subtotal Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Ultrasound Assessment of Gastric Contents in Fasted Surgical Patients With Previous Subtotal Gastrectomy', 'orgStudyIdInfo': {'id': 'L-2018-346'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'fasted patient with previous gastrectomy', 'description': 'The fasted patient with previous subtotal gastrectomy except exclusion criteria are included', 'interventionNames': ['Diagnostic Test: Ultrasound assessment of gastric content']}], 'interventions': [{'name': 'Ultrasound assessment of gastric content', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound assessment of gastric body is performed', 'armGroupLabels': ['fasted patient with previous gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Tae Kyong Kim, MD', 'role': 'CONTACT', 'email': 'ktkktk@gmail.com', 'phone': '82-2-2072-2467'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Tea Kyong Kim, M.D.,Ph. D.', 'role': 'CONTACT', 'email': 'ktkktk@gmail.com', 'phone': '82-2-870-2519'}], 'overallOfficials': [{'name': 'Tea Kyong Kim, M.D.,Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}