Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT04880902
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2021-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy
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': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-10', 'studyFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2021-05-10', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric volume after surgery', 'timeFrame': '1 month', 'description': 'gastric reservoir volume after performance of laparoscopic sleeve gastrectomy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic Sleeve Gastrectomy', 'gastric reservoir', 'Multi-slice computer tomography'], 'conditions': ['Bariatric Surgery Candidate', 'Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate Laparoscopic Sleeve Gastrectomy in the treatment of morbidly obese patients pre and post-operatively after 3 months, 6 months, and 1-year follow-up and assess the volumetric changes of the gastric reservoir 1 year after LSG using multi-slice computer tomography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI of \\> 40 kg/m 2 or \\> 35 kg/m2 with comorbidities e.g. hypertension and type 2 DM.\n* All patients failed in supervised conservative management for obesity for at least 2 years.\n\nExclusion Criteria:\n\n* BMI \\> 60\n* previous bariatric surgery\n* symptomatic reflux oesophagitis disease, gastric pathology (tumor, active peptic ulcer)\n* Significant psychological disorder, active alcohol or substance abuse\n* severe eating disorders (bulimia)\n* severe systemic disease making anesthesia or surgery prohibitively risky (American Society of Anesthesiologists (ASA) class IV'}, 'identificationModule': {'nctId': 'NCT04880902', 'briefTitle': 'Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy: Effect of the Pouch Size on Excessive Weight Loss and Weight Regain', 'orgStudyIdInfo': {'id': '01006786978123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sleeve gastrectomy followed by volumetric assessment', 'interventionNames': ['Procedure: sleeve gastrectomy']}], 'interventions': [{'name': 'sleeve gastrectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic sleeve gastrectomy had evident therapeutic effects on preexisting obesity-related comorbidities. All patients were referred for abdominal MSCT with a volumetric assessment of gastric pouch within 1 month of surgery and 1 year postoperatively', 'armGroupLabels': ['sleeve gastrectomy followed by volumetric assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33516', 'city': 'Kafr ash Shaykh', 'country': 'Egypt', 'facility': 'Kafrelsheikh university', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr, assistant lecturer of General Surgery', 'investigatorFullName': 'Mohamed Ahmed Elkhoby', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}