Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT05269420
Status:
COMPLETED
Last Update Posted:
2022-03-08
First Post:
2022-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Anastomosis Sleeve Jejunal Bypass as a Revisional Bariatric Procedure
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-25', 'studyFirstSubmitDate': '2022-02-25', 'studyFirstSubmitQcDate': '2022-02-25', 'lastUpdatePostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight loss', 'timeFrame': '12 months', 'description': 'percentage of excess weight loss in kilogram'}], 'secondaryOutcomes': [{'measure': 'the rate of improved co morbidity', 'timeFrame': '12 months', 'description': 'the effect of the operation on co morbidity like diabetes and hypertension\n\nthe effect of the operation on co morbidity like diabetes and hypertension the effect of single anastomosis sleeve jejunal bypass of comorbidities'}, {'measure': 'the incidence of nutritional deficiency', 'timeFrame': '12-24 months', 'description': 'the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia.\n\nthe incidence of nutritional deficiency like ca, iron, vitaminD and protein malnutrition'}, {'measure': 'the incidence of early operative complications the incidence of early operative complications the incidence of early operative complications the incidence of complications', 'timeFrame': '12-24 months', 'description': 'early operative complications like leak, bleeding\n\ncomplications like leak, bleeding, dumping,'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band', 'detailedDescription': 'in this study the investigators aim to test the efficacy of single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nobese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity\n\n* patients fit for laparoscopic surgery\n* give approval to share in the study\n* previous restrictive bariatric procedure\n\nExclusion Criteria:\n\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'}, 'identificationModule': {'nctId': 'NCT05269420', 'briefTitle': 'Single Anastomosis Sleeve Jejunal Bypass as a Revisional Bariatric Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Single Anastomosis Sleeve Jejunal Bypass as a Revisional Operation After Restrictive Bariatric Proceures', 'orgStudyIdInfo': {'id': 'ac.med.21.23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAS-J', 'description': 'single anastomosis sleeve Jejunal Bypass as a revisional bariatric procedure after restrictive bariatric procedures', 'interventionNames': ['Procedure: SAS-J']}], 'interventions': [{'name': 'SAS-J', 'type': 'PROCEDURE', 'description': 'Single Anastomosis Sleeve Jejunal Bypass', 'armGroupLabels': ['SAS-J']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61511', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Minia university hospital', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor & consultant of general surgery, Department of Surgery', 'investigatorFullName': 'Alaa Mstafa Hassan Sewefy', 'investigatorAffiliation': 'Minia University'}}}}