Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-03 @ 7:59 PM
Study NCT ID:
NCT03305432
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2017-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative PPI in Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-02', 'studyFirstSubmitDate': '2017-10-04', 'studyFirstSubmitQcDate': '2017-10-04', 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'early postoperative bleeding and leak', 'timeFrame': '2 weeks', 'description': 'early postoperative complications, including bleeding from stable line either intragastric or intraperitoneal and early leak from stable line'}], 'secondaryOutcomes': [{'measure': 'operative time', 'timeFrame': '5 hours', 'description': 'time taken from skin incision to closure'}, {'measure': 'microscopic picture of the removed stomach', 'timeFrame': '2 weeks', 'description': 'histological examination to detect the presence of inflammation in of the removed part of the stomach'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Morbid Obesity']}, 'descriptionModule': {'briefSummary': 'he purpose of this study is to study the effect of preoperative PPI in the early outcome of sleeve gastrectomy', 'detailedDescription': 'In this study 200 morbidly obese patients will be included and will be undergone sleeve gastrectomy. the patients will be randomly assigned into 2 groups, group 1 will be receive PPI preoperative for 10 day and group 2 will not'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Morbidly obese patient with BMI more than 40 with or without co-morbidity\n* Morbidly obese patient with BMI more than 35 with co-morbidity\n\nExclusion Criteria:\n\n* Unfit patients for laparoscopic sleeve gastrectomy\n* patients refuse to share in the study\n* patients that already on PPI due to any indications\n* revisional surgery for obesity\n* previous upper abdominal surgery'}, 'identificationModule': {'nctId': 'NCT03305432', 'briefTitle': 'Preoperative PPI in Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Routine Preoperative PPI in Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'fac.med.043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PPI group', 'description': 'take preoperative PPI for 10 days', 'interventionNames': ['Combination Product: sleeve + preoperative PPI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'take placebo for for 10 days preoperative', 'interventionNames': ['Combination Product: sleeve + preoperative Placebo']}], 'interventions': [{'name': 'sleeve + preoperative PPI', 'type': 'COMBINATION_PRODUCT', 'description': 'sleeve + preoperative PPI', 'armGroupLabels': ['PPI group']}, {'name': 'sleeve + preoperative Placebo', 'type': 'COMBINATION_PRODUCT', 'description': 'sleeve + preoperative Placebo', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61511', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alaa Mstafa Hassan Sewefy', 'investigatorAffiliation': 'Minia University'}}}}