Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT05145205
Status:
COMPLETED
Last Update Posted:
2021-12-06
First Post:
2021-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2021-11-23', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight dissipation', 'timeFrame': '12 months', 'description': 'decrease the body mass index by 1 or more'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laparoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'This is a retrospective work on 200 morbid obese patients randomized and categorized into 2 groups according to the treatment method: the laparoscopic sleeve gastrectomy (LSG) and LRYGB groups, within the period from 2014 to 2019 and matched weight dissipation, complications, life quality, and negative events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study included Egyptian patients with age ranging from 18 to 70 seeking surgical operation for obesity.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients of (Body Mass Index) more than 40, with at least 1 comorbidity\n\nExclusion Criteria:\n\n* All patients of (Body Mass Index) less than 40,\n* No comorbidities\n* Patients who refused the surgical procedures.'}, 'identificationModule': {'nctId': 'NCT05145205', 'briefTitle': 'Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity', 'orgStudyIdInfo': {'id': 'AUH210021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LSG', 'interventionNames': ['Procedure: Sleeve gastrectomy']}, {'label': 'RYGB', 'interventionNames': ['Procedure: Laparoscopic Roux-en-Y gastric bypass']}], 'interventions': [{'name': 'Sleeve gastrectomy', 'type': 'PROCEDURE', 'description': 'Bougie was applied over the lower curvature to adjust the gastric tube then longitudinal amputation of the stomach was performed for about 4 to 6 cm per pecker of the pylorus to the corner of His. No supportive materials were used, and over-suturing of the basic line performed only over the points of bleeding.\n\nAll resected specimens were sent to histopathology laboratory for examination.', 'armGroupLabels': ['LSG']}, {'name': 'Laparoscopic Roux-en-Y gastric bypass', 'type': 'PROCEDURE', 'description': 'An antecolic and antegastric RYGB become executed with a 150 cm alimentary limb with both a linearly or circularly kink (25 mm) gastrojejunostomy in step with the desire of the surgeon. A 50-cm-lengthy biliopancreati', 'armGroupLabels': ['RYGB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11884', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Azhar faculty of medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Abdulkarim Hasan', 'investigatorAffiliation': 'Al-Azhar University'}}}}