Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06223620
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2023-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicenter Retrospective Review of Management Strategies in Small Bowel Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 504}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2024-01-16', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morbidity and length of stay', 'timeFrame': '1 year', 'description': 'Morbidity and length of stay'}], 'secondaryOutcomes': [{'measure': 'Patient demographics', 'timeFrame': '1 year', 'description': 'number of patients (age, sex, weight, height)'}, {'measure': 'admit date', 'timeFrame': '1 year', 'description': 'Number of patients admitting to the hospital'}, {'measure': 'discharge date', 'timeFrame': '1 year', 'description': 'number of patients discharging'}, {'measure': 'admission service', 'timeFrame': '1 year', 'description': 'Number of services related to admissions'}, {'measure': 'Aspirin(ASA )class', 'timeFrame': '1 year', 'description': 'number of aspirin class'}, {'measure': 'comorbidities', 'timeFrame': '1 year', 'description': 'number of comorbidities associated'}, {'measure': 'surgical history', 'timeFrame': '1 year', 'description': 'number of surgeries in the past'}, {'measure': 'labs', 'timeFrame': '1 year', 'description': 'number of labs done'}, {'measure': 'time of contrast given', 'timeFrame': '1 year', 'description': 'rate of Contrast given'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SBO - Small Bowel Obstruction']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to review performance of water soluble contrast study in patients admitted with Small Bowel Obstruction(SBO), will improve quality and safety, and decrease length of stay and morbidity.', 'detailedDescription': 'Performance of contrast study has been a part of the protocols at multiple institutions of the southwestern surgical congress. Plan to perform a retrospective review of management protocols at these institutions. Wish to know whether the implementation of a standardized, protocol-driven pattern of practice involving the performance of water soluble contrast study in patients admitted with SBO, will improve quality and safety, and decrease length of stay and morbidity.\n\nThe objective of the study is to review performance of water soluble contrast study in patients admitted with SBO, will improve quality and safety, and decrease length of stay and morbidity.\n\nPerformance of contrast study has been a part of the protocols at multiple institutions of the southwestern surgical congress.\n\nHypothesize that implementation of a standardized, protocol-driven pattern of practice involving the performance of water soluble contrast study in patients admitted with SBO, will improve quality and safety, and decrease length of stay and morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Previous studies found on an average 3.9 to 9.4% patient suffer from SBO. The disease incidence varies depending on the cause of obstruction. Assuming that 3.9% of the patients will be affected by SBO, the study would require a sample size of 504 for estimating the expected proportion with 3% absolute precision and 95% confidence.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Adults aged 18-89 years of age\n\n * Patients presenting with SBO\n\nExclusion Criteria:\n\n* • Prisoners\n\n * Pregnant women'}, 'identificationModule': {'nctId': 'NCT06223620', 'briefTitle': 'A Multicenter Retrospective Review of Management Strategies in Small Bowel Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'Methodist Health System'}, 'officialTitle': 'A Multicenter Retrospective Review of Management Strategies in Small Bowel Obstruction', 'orgStudyIdInfo': {'id': '046.GME.2018.D'}}, 'armsInterventionsModule': {'interventions': [{'name': 'review performance of water soluble contrast', 'type': 'OTHER', 'description': 'review performance of water soluble contrast study in patients admitted with SBO, will improve quality and safety, and decrease length of stay and morbidity.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75201', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Dallas Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Michael Truitt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Methodist Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}