Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-01-17 @ 10:25 AM
Study NCT ID:
NCT06530212
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleeve Gastrectomy With Jejuno-ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass
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': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-27', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stoma complications', 'timeFrame': 'one year', 'description': 'any complication due to sleeve jejunal anastomosis'}], 'secondaryOutcomes': [{'measure': 'weight loss at one year', 'timeFrame': 'one year', 'description': 'the effect of the 2 procedures on weight measured by percentage of excess weight loss'}, {'measure': 'improvement of comorbidities', 'timeFrame': 'one year', 'description': 'change in comorbidities'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'sleeve gastrectomy with jejunoileal bypass (SGJIB) is a novel technique for the surgical treatment of obesity. The aim of the study is to compare this maneuver with single anastomosis sleeve jejunal bypass (SAS-JB)', 'detailedDescription': '200 patients will be randomly divided into to equal . Group 1 will be operated by sleeve gastrectomy with jejunoileal bypass with the anastomosis between the jejunum at about 100 cm from the duodeno-jejunal flexure and the ileum at 250 cm from the ileocaecal junction. and group 2 will be operated by single anastomosis sleeve jejunal bypass (SAS-JB) with biliary limb equal one third of total intestinal length.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 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': 'NCT06530212', 'briefTitle': 'Sleeve Gastrectomy With Jejuno-ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Sleeve Gastrectomy With Jejuno-ieal Bypass', 'orgStudyIdInfo': {'id': 'ac.med.24.34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SGJIB', 'interventionNames': ['Procedure: SGJIB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SAS-JB', 'interventionNames': ['Procedure: SAS-JB']}], 'interventions': [{'name': 'SGJIB', 'type': 'PROCEDURE', 'description': 'sleeve gastrectomy with jejunoileal bypass with anastomosis between the jejunum at about 100 cm from the duodeno-jejunal flexure and the ileum at 250 cm from the ileocaecal junction.', 'armGroupLabels': ['SGJIB']}, {'name': 'SAS-JB', 'type': 'PROCEDURE', 'description': 'single anastomosis sleeve jejunal bypass (SAS-JB) with biliary limb equal one third of total intestinal length.', 'armGroupLabels': ['SAS-JB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61511', 'city': 'Minya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Alaa M Sewefy, MD', 'role': 'CONTACT', 'email': 'sewafy@yahoo.co.uk', 'phone': '+201006448805'}, {'name': 'M', 'role': 'CONTACT'}, {'name': 'Alaa Sewefy, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Taha Kayed, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'centralContacts': [{'name': 'Alaa sewefy, professor', 'role': 'CONTACT', 'email': 'sewafy@yahoo.co.uk', 'phone': '+201006448805'}], 'overallOfficials': [{'name': 'Alaa Sewefy, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minia University, faculty of medicine'}, {'name': 'Taha Kayed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Minia University, faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of general and bariatric surgery', 'investigatorFullName': 'Alaa Mstafa Hassan Sewefy', 'investigatorAffiliation': 'Minia University'}}}}