Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT00632593
Status:
COMPLETED
Last Update Posted:
2008-03-10
First Post:
2008-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial Comparing Early Complications of Two Techniques in the Laparoscopic Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-07', 'studyFirstSubmitDate': '2008-02-28', 'studyFirstSubmitQcDate': '2008-03-07', 'lastUpdatePostDateStruct': {'date': '2008-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Early Complications of both techniques', 'Fistula rate', 'Dehiscence rate', 'reoperation rate and cause'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to define and evaluate the early complications between two different surgical techniques used to perform a laparoscopic gastric bypass'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass Index between 35 with comorbidities and 50 kg/mt2\n\nExclusion Criteria:\n\n* Body mass index \\<35kg7mt2 and \\>50kg/mt2'}, 'identificationModule': {'nctId': 'NCT00632593', 'briefTitle': 'Trial Comparing Early Complications of Two Techniques in the Laparoscopic Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'Prospective Randomized Trial Comparing Early Complications of Hand-Sewn Versus Circular Stapled Gastro-Jejunal Anastomosis in Laparoscopic Gastric Bypass', 'orgStudyIdInfo': {'id': 'BPGlap1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Circular Stapled', 'description': 'Patients operated performing the gastric pouch of the gastric bypass with a circular staple device', 'interventionNames': ['Procedure: Laparoscopic Gastric Bypass']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Handsewn anastomosis', 'description': 'Patients operated performing the gastric pouch of the gastric bypass in a handsewn manner', 'interventionNames': ['Procedure: Laparoscopic Gastric Bypass']}], 'interventions': [{'name': 'Laparoscopic Gastric Bypass', 'type': 'PROCEDURE', 'armGroupLabels': ['Circular Stapled']}, {'name': 'Laparoscopic Gastric Bypass', 'type': 'PROCEDURE', 'armGroupLabels': ['Handsewn anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'University Hospital Of Bellvitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Leonardo J Silvio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari de Bellvitge'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Leonardo J Silvio', 'oldOrganization': 'University Hospital of Bellvitge'}}}}