Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 6:54 PM
Study NCT ID:
NCT05591833
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2022-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Anastomosis Sleeve 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2022-05-07', 'studyFirstSubmitQcDate': '2022-10-19', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'nutritional deficiency', 'timeFrame': '12 months', 'description': 'the effect of the 2 procedures on nutritional status by doing the following investigations to collectively give idea about deficiency this investigation including: Hb% ( in mg/dL), vitamin D (in ng/mL) , vitamin B ( in pg/mL), Serum Ca (in mg/dL) serum Zinc (in μg/dL) serum Iron ( in mcg/dL) serum Folate (in μg/L) and serum albumin ( in g/dL)'}], 'secondaryOutcomes': [{'measure': 'comorbidities', 'timeFrame': '1 year', 'description': 'change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer'}, {'measure': 'complications', 'timeFrame': '1 year', 'description': 'early and late complications'}, {'measure': 'weight loss', 'timeFrame': '12 months', 'description': 'the effect of the 2 procedures on weight measured by percentage of excess weight loss'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'to compare the results of SASI to SAS-J in treatment of morbid obesity', 'detailedDescription': '200 of patients indicated for obesity surgery will be divided into 2 groups : Group 1, will be operated by SASI and Group 2, will be operated by SAS-J'}, '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': 'NCT05591833', 'briefTitle': 'Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal as a Treatment of Morbid Obesity', 'orgStudyIdInfo': {'id': 'fac.med 22.26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SASI', 'interventionNames': ['Procedure: SASI']}, {'type': 'EXPERIMENTAL', 'label': 'SAS-J', 'interventionNames': ['Procedure: SAS-J']}], 'interventions': [{'name': 'SASI', 'type': 'PROCEDURE', 'description': 'Single-Anastomosis Sleeve ileal (SASI) Bypass', 'armGroupLabels': ['SASI']}, {'name': 'SAS-J', 'type': 'PROCEDURE', 'description': 'Single-Anastomosis Sleeve Jejunal (SAS-J) 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 and laparo-endoscopy', 'investigatorFullName': 'Alaa Mstafa Hassan Sewefy', 'investigatorAffiliation': 'Minia University'}}}}