Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT05912920
Status:
UNKNOWN
Last Update Posted:
2023-08-01
First Post:
2023-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic Natural Gastric Banding for Morbid Obesity
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-29', 'studyFirstSubmitDate': '2023-06-11', 'studyFirstSubmitQcDate': '2023-06-11', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '%EWL', 'timeFrame': '12 months', 'description': 'percentage of excess weight loss at one year'}], 'secondaryOutcomes': [{'measure': 'complications rate', 'timeFrame': '12 months', 'description': 'the incidence of complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'to do gastric banding using round ligament or omental flap instead of synesthetic band', 'detailedDescription': 'the round ligament or omental flap is used for gastric band instead of synesthetic band which had many complications that led to its abandon'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '18 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* 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': 'NCT05912920', 'briefTitle': 'Laparoscopic Natural Gastric Banding for Morbid Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Laparoscopic Natural Gastric Banding for Management of Morbid Obesity', 'orgStudyIdInfo': {'id': 'fac.med 23.25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'gastric band', 'description': 'to do gastric banding use either round ligament or omental flap', 'interventionNames': ['Procedure: gastric band']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sleeve gastrectomy', 'description': 'to do sleeve gastrectomy as standard', 'interventionNames': ['Procedure: gastric band']}], 'interventions': [{'name': 'gastric band', 'type': 'PROCEDURE', 'description': 'gastric band', 'armGroupLabels': ['gastric band', 'sleeve gastrectomy']}]}, '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'}], 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}, {'zip': '61511', 'city': 'Minya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Alaa M Sewefy, MD', 'role': 'CONTACT', 'email': 'sewafy@yahoo.co.uk', 'phone': '+201006448805'}], 'facility': 'Minia university hospital', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof.', 'investigatorFullName': 'Alaa Mstafa Hassan Sewefy', 'investigatorAffiliation': 'Minia University'}}}}