Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT05204420
Status:
COMPLETED
Last Update Posted:
2022-01-24
First Post:
2022-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spontaneous Gastric Intramural Hematoma: Case Report and Literature Review
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-12', 'studyFirstSubmitDate': '2022-01-12', 'studyFirstSubmitQcDate': '2022-01-12', 'lastUpdatePostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spontaneous gastric intramural hematoma', 'timeFrame': '1 month', 'description': 'Spontaneous gastric intramural hematoma'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Patient previously healthy found to have spontaneous gastric intramural hematoma', 'detailedDescription': "28 year old male patient previously healthy presented with diarrhea and diffuse abdominal pain of 1 week duration that exacerbated 1 day prior to presentation. CT showed anterior abdominal mass possibly from the outer gastric wall. Gastroscopy suspected a submucosal tumor in the body and antrum. Patient's pain exacerbated and developed drop in hemoglobin. Urgent CT scan showed a bleeding gastric tumor. Urgent laparotomy identified a bleeding gastric lesion at greater curvature. Partial gastrectomy done with abutting mesocolon resection. Surgical specimen pathology showed gastric intramural hematoma that was considered spontaneous."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients previously healthy presenting with bleeding gastric mass', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any patient presenting with gastric bleeding tumors\n\nExclusion Criteria:\n\n* patients on anticoagulants and patient with gastric medical history'}, 'identificationModule': {'nctId': 'NCT05204420', 'briefTitle': 'Spontaneous Gastric Intramural Hematoma: Case Report and Literature Review', 'organization': {'class': 'OTHER', 'fullName': 'University of Balamand'}, 'officialTitle': 'Spontaneous Gastric Intramural Hematoma: Case Report and Literature Review', 'orgStudyIdInfo': {'id': 'UBalamand'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gastric wide local excision for bleeding mass', 'type': 'PROCEDURE', 'description': 'Laparoscopic partial gastrectomy for gastric submucosal mass'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'University of Balamand', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Omar Tabbikha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Balamand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Publishing a case report of our finding'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Balamand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General Surgery Resident', 'investigatorFullName': 'Omar Tabbikha', 'investigatorAffiliation': 'University of Balamand'}}}}