Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
Study NCT ID:
NCT05803668
Status:
UNKNOWN
Last Update Posted:
2023-07-18
First Post:
2023-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence of Cholelithiasis After Bariatric Surgery in Sohag University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-02', 'releaseDate': '2024-06-26'}], 'estimatedResultsFirstSubmitDate': '2024-06-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-14', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-03-27', 'lastUpdatePostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who develop gall bladder stones after bariatric surgery', 'timeFrame': 'one year', 'description': 'Evalution of gall bladder stone formation postoperaive and its relation with comorbidities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholelithiasis']}, 'descriptionModule': {'briefSummary': 'To study the incidence and predictors of developing symptomatic gallstone disease following bariatric surgery.', 'detailedDescription': 'To study the incidence and predictors of developing symptomatic gallstone disease following bariatric surgery.\n\nA retrospective study with prospective collective data will be conducted including all patients underwent bariatric surgery in general surgical department, Sohag University between January 2015 and December 2022 who did not have gallstones in the preoperative abdominal ultrasound examinations.\n\nMedical records will be reviewed. Demographic data such as age, gender, BMI, comorbidities as ( DM, hypertension and hyperlipidemia ) and time elapsed between the surgery to post-surgery US examination. The findings of the US examinations will be collected and analyzed. Data will be analyzed to obtain descriptive and inferential statistics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients underwent Bariatric Surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients underwent bariatric surgery with minimum postoperative follow up period of one year duration will be included in the study.\n\nExclusion Criteria:\n\n* Patients who had cholecystectomy during the bariatric surgery.\n* Pediatric age.'}, 'identificationModule': {'nctId': 'NCT05803668', 'briefTitle': 'Incidence of Cholelithiasis After Bariatric Surgery in Sohag University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Incidence of Cholelithiasis After Bariatric Surgery in Sohag University Hospital', 'orgStudyIdInfo': {'id': 'soh-Med-23-03-06MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients who developed gall stones'}, {'label': 'patients who did not develope gall stones'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag University', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of general surgery of sohag university hospital', 'investigatorFullName': 'Ahmed Salah Mohamed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-06-26', 'type': 'RELEASE'}, {'date': '2024-10-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ahmed Salah Mohamed, Resident of general surgery of sohag university hospital, Sohag University'}}}}