Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-28 @ 6:16 PM
Study NCT ID:
NCT04823767
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2021-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Anastomosis Sleeve Iejenal Bypass in Obese Patient With Hiatus Hernia
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': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-28', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-28', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the effect of sleeve jejunal bypass on reflux manifestations', 'timeFrame': '2 months', 'description': 'evaluation of the effect of sleeve jejunal bypass on reflux manifestations'}], 'secondaryOutcomes': [{'measure': 'EWL', 'timeFrame': 'one year', 'description': 'excess weight loss at one year'}, {'measure': 'treatment of comorbidities', 'timeFrame': 'one year', 'description': 'effect on obesity comorbidities'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'single anastomosis sleeve jejunal bypass with hiatal repair for morbid obesity with reflux manifestations', 'detailedDescription': 'preoperative endoscopy was done and if hiatus hernia was present the patient is undergo single anastomosis sleeve jejunal bypass with hiatal repair for morbid obesity with reflux manifestations'}, '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': 'NCT04823767', 'briefTitle': 'Single Anastomosis Sleeve Iejenal Bypass in Obese Patient With Hiatus Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Single Anastomosis Sleeve Iejenal Bypass With Crural Repair in Obese Patient With Hiatus Hernia', 'orgStudyIdInfo': {'id': 'fac,med 20.3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single anastomosis sleeve jejunal bypass with hiatal repair', 'description': 'Single anastomosis sleeve jejunal bypass with hiatal repair', 'interventionNames': ['Other: Single anastomosis sleeve jejunal bypass with hiatal repair']}], 'interventions': [{'name': 'Single anastomosis sleeve jejunal bypass with hiatal repair', 'type': 'OTHER', 'description': 'Single anastomosis sleeve jejunal bypass with hiatal repair', 'armGroupLabels': ['Single anastomosis sleeve jejunal bypass with hiatal repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61511', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Proffessor', 'investigatorFullName': 'Alaa Mstafa Hassan Sewefy', 'investigatorAffiliation': 'Minia University'}}}}