Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT03465956
Status:
UNKNOWN
Last Update Posted:
2018-03-20
First Post:
2018-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic Sleeve Gastrectomy Short Term Follow up
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', 'interventionModelDescription': 'All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or \\> 35 kg/m2 associated with co-morbidity).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-16', 'studyFirstSubmitDate': '2018-02-21', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of excess weight loss', 'timeFrame': 'First six months after surgery', 'description': 'Assessment of excess weight loss six months after the operation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '21423553', 'type': 'BACKGROUND', 'citation': 'Nosso G, Angrisani L, Saldalamacchia G, Cutolo PP, Cotugno M, Lupoli R, Vitolo G, Capaldo B. Impact of sleeve gastrectomy on weight loss, glucose homeostasis, and comorbidities in severely obese type 2 diabetic subjects. J Obes. 2011;2011:340867. doi: 10.1155/2011/340867. Epub 2011 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'Laparoscopic Sleeve Gastrectomy (LSG), Also known as longitudinal or vertical gastrectomy.\n\nLSG was initially considered a first-stage operation in high-risk patients before bilio-pancreatic diversion or Roux-en-Y gastric bypass surgery. However, LSG was subsequently found to be effective as a single procedure for treatment of morbid obesity.LSG functions mainly as a restrictive procedure in which about 75 % of the stomach is removed leaving a narrow gastric tube or sleeve. So, it limits the amount of food that can be eaten at one time via inducing early satiety after eating a small amount of food due to early distension of the fashioned gastric sleeve giving a sense of satiety, consequently losing excess body weight by time.Sleeve gastrectomy may also cause a decrease in appetite by reducing the amount of Ghrelin (hunger hormone) produced by the stomach.', 'detailedDescription': 'All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or \\> 35 kg/m2 associated with co-morbidity) randomly admitted to Assiut University Hospital-General Surgery Department.\n\nPre-operative: Assessment of; BMI (Body Mass Index), Fasting Blood Glucose level (FBG), Associated Co-morbidities (as hypertensions \\& sleep apnea).\n\nOperative (During Operation):\n\nAll patients undergo LSG by single team work with intra-operative oesophageal bougie 36 french with use of laparoscopic gastro-intestinal anastomosis(GIA) stapler.\n\nPost-operative:\n\nPatients are discharged from the hospital after they can start oral diet.\n\nPost-operative evaluation of:\n\n1. Complications:\n\n 1. Early complications: during the first 2 weeks after surgery,which include hemorrhage (intra-luminal or extra-luminal), staple line leak, vomiting and infection (surgical site infection or intra- abdominal abscess formation)\n 2. Late complications: from 2 weeks to 6 months post-operative, which include stricture of the gastric sleeve, gastro-esophageal reflux disease (GERD) and nutritional deficiencies.\n2. Excess weight loss (EWL) by using BMI Follow up of patients at fifteen days, one month, two months, three months and six months after surgery.\n3. Assessment of Blood Glucose level during visits.\n4. Measurement of blood pressure during visits (if there is associated hypertension).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or \\> 35 kg/m2 associated with co-morbidity), and are fit for laparoscopic surgery.\n\nExclusion Criteria:\n\n* Patients having severe co-morbidity who are not fit for surgery or general anaesthesia.\n* Patients with age below 20 years or above 50 years.'}, 'identificationModule': {'nctId': 'NCT03465956', 'briefTitle': 'Laparoscopic Sleeve Gastrectomy Short Term Follow up', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Laparoscopic Sleeve Gastrectomy Short Term Follow up', 'orgStudyIdInfo': {'id': 'Mohamed gamal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Laparoscopic Sleeve Gastrectomy', 'description': 'Laparoscopic sleeve gastrectomy for patients with morbid obesity using the gastro-intestinal anastomosis stapler.', 'interventionNames': ['Procedure: Laparoscopic Sleeve Gastrectomy']}], 'interventions': [{'name': 'Laparoscopic Sleeve Gastrectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic Sleeve Gastrectomy using the gastro-intestinal anastomosis stapler.', 'armGroupLabels': ['Laparoscopic Sleeve Gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Gamal', 'role': 'CONTACT', 'email': 'gamal.m53@yahoo.com', 'phone': '01026674177'}], 'facility': 'AssiutU', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Mohamed Gamal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Gamal Thabet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Assiut University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mohamed Gamal Thabet', 'investigatorAffiliation': 'Assiut University'}}}}