Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:42 PM
Study NCT ID:
NCT04144361
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2019-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-28', 'studyFirstSubmitDate': '2019-10-20', 'studyFirstSubmitQcDate': '2019-10-27', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of postoperative stable line bleeding', 'timeFrame': '2-24 hours', 'description': 'early postoperative bleeding from stable line'}, {'measure': 'the incidence of stable line leakage', 'timeFrame': '1-30 days', 'description': 'leak from stable line'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post sleeve gastrectomy leak', 'post sleeve gastrectomy'], 'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the aim is to test the effect of pilcation on the incidence of leaks and bleeding', 'detailedDescription': 'three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the primary outcomes is the incidence of leaks and bleeding which is the main nightmare of sleeve gastrectomy, secondary outcome operative time, weight loss and metabolic effect'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity\n* patients fit for laparoscopic surgery\n* give approval to share in the study\n\nExclusion Criteria:\n\n* patients refused to share in the study\n* patients unfit for surgery\n* patients aged less than 18 and older than 60\n* patient with previous upper abdominal surgery either for obesity or other diseases\n* revisional bariatric procedures'}, 'identificationModule': {'nctId': 'NCT04144361', 'briefTitle': 'Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Outcomes of Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication', 'orgStudyIdInfo': {'id': 'fac,med 19.32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sleeve without plication', 'description': 'sleeve gastrectomy on bougie 36 without plication', 'interventionNames': ['Procedure: sleeve without plication']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sleeve with plication', 'description': 'sleeve gastrectomy on bougie 42 without plication', 'interventionNames': ['Procedure: sleeve with plication']}], 'interventions': [{'name': 'sleeve with plication', 'type': 'PROCEDURE', 'description': 'sleeve with plication', 'armGroupLabels': ['sleeve with plication']}, {'name': 'sleeve without plication', 'type': 'PROCEDURE', 'description': 'sleeve without plication', 'armGroupLabels': ['sleeve without plication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61511', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}, {'zip': '61511', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Minya university hospital', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'alaa M Sewefy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor and consultant of general surgery', 'investigatorFullName': 'Alaa Mstafa Hassan Sewefy', 'investigatorAffiliation': 'Minia University'}}}}