Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT03607305
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2018-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 506}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-23', 'studyFirstSubmitDate': '2018-07-23', 'studyFirstSubmitQcDate': '2018-07-23', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '5 years after surgery', 'description': 'Weight loss was evaluated'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Weight Loss']}, 'referencesModule': {'references': [{'pmid': '31104282', 'type': 'DERIVED', 'citation': 'Ruiz-Tovar J, Vorwald P, Gonzalez-Ramirez G, Posada M, Salcedo G, Llavero C, Garcia-Olmo D. Impact of Biliopancreatic Limb Length (70 cm vs 120 cm), with Constant 150 cm Alimentary Limb, on Long-Term Weight Loss, Remission of Comorbidities and Supplementation Needs After Roux-En-Y Gastric Bypass: a Prospective Randomized Clinical Trial. Obes Surg. 2019 Aug;29(8):2367-2372. doi: 10.1007/s11695-019-03717-7.'}]}, 'descriptionModule': {'briefSummary': 'Patients were randomly assigned into 2 groups: those patients undergoing RYGB with a BPL of 70cm and those ones undergoing RYGB with a BPL of 120 cm.\n\nExcess BMI loss 5 years after surgery was investigated', 'detailedDescription': 'Patients were randomly assigned into 2 groups: those patients undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 70cm and those ones undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 120 cm. Alimentary limb was constant in both groups (150cm).\n\nExcess BMI loss 5 years after surgery was investigated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>40 Kg/m2\n* BMI \\> 35 Kg/m2 with the presence of comorbidities associated to obesity\n* Age older than 18 years\n\nExclusion Criteria:\n\n* Patients undergoing other bariatric techniques than RYGB\n* Patients undergoing RYGB with different BPL or AL lengths than that reported for this study\n* Any other surgical procedure added to the bariatric surgery\n* Impossibility to comply with pre-established clinical follow-up.'}, 'identificationModule': {'nctId': 'NCT03607305', 'briefTitle': 'Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Elche'}, 'officialTitle': 'Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric', 'orgStudyIdInfo': {'id': 'HGUE 2012-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BP limb 70cm', 'description': 'Patients underwent a RYGB with a biliopancreatic limb of 70cm', 'interventionNames': ['Procedure: BP limb 70cm']}, {'type': 'EXPERIMENTAL', 'label': 'BP limb 120cm', 'description': 'Patients underwent a RYGB with a biliopancreatic limb of 120cm', 'interventionNames': ['Procedure: BP limb 120cm']}], 'interventions': [{'name': 'BP limb 70cm', 'type': 'PROCEDURE', 'description': 'Performance of RYGB with a BP limb of 70cm', 'armGroupLabels': ['BP limb 70cm']}, {'name': 'BP limb 120cm', 'type': 'PROCEDURE', 'description': 'Performance of RYGB with a BP limb of 120cm', 'armGroupLabels': ['BP limb 120cm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jaime Ruiz-Tovar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOSPITAL REY JUAN CARLOS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario Elche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Jaime Ruiz-Tovar, MD, PhD', 'investigatorAffiliation': 'Hospital General Universitario Elche'}}}}