Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-30 @ 8:37 PM
Study NCT ID:
NCT06884995
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2025-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation of Weight Loss With Residual Gastric Volume and Shape on Computerized Tomography in Patients Undergoing Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'volume of sleeve and shape', 'timeFrame': '12 months', 'description': 'relation with weight loss'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['shape, Sleeve gastrectomy, inadequate weight loss, volumetry'], 'conditions': ['Weight Regain Post Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'Laparoscopic sleeve gastrectomy (LSG) has been accepted as a primary bariatric procedure. The aim of the study was to evaluate the volume and the morphologies of remnant stomachs after LSG and their association with weight loss', 'detailedDescription': 'Twenty patients who underwent Laparoscopic sleeve gastrectomy (LSG) were followed prospectively and evaluated at 12 months after operation using computed tomography CT with 3D reconstruction to evaluate the shape and volume of the residual stomach after LSG. Total sleeve volume (TSV), tube volume (TV), antral volume (AV) and tube/antral volume ratio (TAVR) were included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Twenty patients who underwent Laparoscopic sleeve gastrectomy (LSG) were followed prospectively and evaluated at 12 months after operation using computed tomography CT with 3D reconstruction to evaluate the shape and volume of the residual stomach after LSG', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* candidate for sleeve gastrectomy\n\nExclusion Criteria:\n\n* revisional surgery'}, 'identificationModule': {'nctId': 'NCT06884995', 'briefTitle': 'Correlation of Weight Loss With Residual Gastric Volume and Shape on Computerized Tomography in Patients Undergoing Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Helwan University'}, 'officialTitle': 'Correlation of Weight Loss With Residual Gastric Volume and Shape on Computerized Tomography in Patients Undergoing Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'helwan university 84-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': '20 patients had sleeve gastrectomy', 'description': 'after 12 months ,volumetry study was done'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helwan', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Helwan University', 'geoPoint': {'lat': 29.84144, 'lon': 31.30084}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helwan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecteurer of general surgery', 'investigatorFullName': 'Mahmoud alazawy', 'investigatorAffiliation': 'Helwan University'}}}}