Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-28 @ 7:05 PM
Study NCT ID:
NCT00951093
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2009-08-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'madalosso@gastrobese.com.br', 'phone': '+55(54)3045-4070', 'title': 'Carlos AS Madalosso, Director of Department of Metabolic and Bariatric Surgery', 'organization': 'Clinica Gastrobese'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Serious and Other Non-Serious Adverse Events were not collected/assessed during the study', 'eventGroups': [{'id': 'EG000', 'title': 'Patients Assessed for GERD', 'description': 'Patients who had an open gastric bypass were assessed for GERD before and after surgery', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Presenting Reflux Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Before GBP', 'description': 'Patients assessed for GERD before Gastric Bypass Surgery'}, {'id': 'OG001', 'title': '6 Months After GBP', 'description': 'Patients assessed for GERD 6 months after Gastric Bypass Surgery'}, {'id': 'OG002', 'title': '39 Months After GBP', 'description': 'Patients assessed for GERD 39 months after Gastric Bypass Surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'P value adjusted for multiple comparisons', 'statisticalMethod': 'Friedman´s test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'followed by nonparametric pairwise multiple comparisons'}], 'paramType': 'NUMBER', 'timeFrame': 'Before GBP, 6 months after GBP and 39 months after GBP', 'description': 'Prevalence of typical reflux syndrome according to the Montreal Consensus. This Consensus institutes that GERD can be outlined when troublesome symptoms and/or complications induced by reflux of the gastric content back to the esophagus are present.\n\nIn order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language was used.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Esophageal Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Before GBP', 'description': 'Patients assessed for GERD before Gastric Bypass Surgery'}, {'id': 'OG001', 'title': '6 Months After GBP', 'description': 'Patients assessed for GERD 6 months after Gastric Bypass Surgery'}, {'id': 'OG002', 'title': '39 Months After GBP', 'description': 'Patients assessed for GERD 39 months after Gastric Bypass Surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Friedman´s test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'followed by nonparametric pairwise multiple comparisons'}], 'paramType': 'NUMBER', 'timeFrame': 'Before GBP, 6 months after GBP and 39 months after GBP', 'description': 'Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Gastroesophageal Reflux Disease (GERD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Before GBP', 'description': 'Patients assessed for GERD before Gastric Bypass Surgery'}, {'id': 'OG001', 'title': '6 Months After GBP', 'description': 'Patients assessed for GERD 6 months after Gastric Bypass Surgery'}, {'id': 'OG002', 'title': '39 Months After GBP', 'description': 'Patients assessed for GERD 39 months after Gastric Bypass Surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Friedman´s test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Before GBP, 6 months after GBP and 39 months after GBP', 'description': 'Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Esophageal Acid Exposure at 24h pH Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Before GBP', 'description': 'Patients assessed for GERD before Gastric Bypass Surgery'}, {'id': 'OG001', 'title': '6 Months After GBP', 'description': 'Patients assessed for GERD 6 months after Gastric Bypass Surgery'}, {'id': 'OG002', 'title': '39 Months After GBP', 'description': 'Patients assessed for GERD 39 months after Gastric Bypass Surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '8.0'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '6.3'}, {'value': '0.1', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.4'}]}]}], 'analyses': [{'pValue': '< 0.020', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'followed by nonparametric pairwise multiple comparisons'}], 'paramType': 'MEDIAN', 'timeFrame': 'Before GBP, 6 months after GBP and 39 months after GBP', 'description': 'Esophageal acid exposure was measured through 24h pH monitoring. During the entire period, esophageal pH was measured and recorded as the percent of time pH was below 4.', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Esophageal Acid Exposure at 24h pH Monitoring in Upright Position', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Before GBP', 'description': 'Patients assessed for GERD before Gastric Bypass Surgery'}, {'id': 'OG001', 'title': '6 Months After GBP', 'description': 'Patients assessed for GERD 6 months after Gastric Bypass Surgery'}, {'id': 'OG002', 'title': '39 Months After GBP', 'description': 'Patients assessed for GERD 39 months after Gastric Bypass Surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '8.7'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.7'}, {'value': '0.1', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'followed by nonparametric pairwise multiple comparisons'}], 'paramType': 'MEDIAN', 'timeFrame': 'Before GBP, 6 months after GBP and 39 months after GBP', 'description': 'Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in upright position', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Esophageal Acid Exposure at 24h pH Monitoring in Supine Position', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Before GBP', 'description': 'Patients assessed for GERD before Gastric Bypass Surgery'}, {'id': 'OG001', 'title': '6 Months After GBP', 'description': 'Patients assessed for GERD 6 months after Gastric Bypass Surgery'}, {'id': 'OG002', 'title': '39 Months After GBP', 'description': 'Patients assessed for GERD 39 months after Gastric Bypass Surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '6.3'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'followed by nonparametric pairwise multiple comparisons'}], 'paramType': 'MEDIAN', 'timeFrame': 'Before GBP, 6 months after GBP and 39 months after GBP', 'description': 'Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in supine position', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Increased Acid Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Before GBP', 'description': 'Patients assessed for GERD before Gastric Bypass Surgery'}, {'id': 'OG001', 'title': '6 Months After GBP', 'description': 'Patients assessed for GERD 6 months after Gastric Bypass Surgery'}, {'id': 'OG002', 'title': '39 Months After GBP', 'description': 'Patients assessed for GERD 39 months after Gastric Bypass Surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Friedman´s test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'followed by nonparametric pairwise multiple comparisons'}], 'paramType': 'NUMBER', 'timeFrame': 'Before GBP, 6 months after GBP and 39 months after GBP', 'description': 'Increased Acid Exposure occurs when esophageal pH is \\<4 for a period longer than 4% of the total test time on a 24h pH monitoring.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Assessed for GERD', 'description': 'Patients assessed for GERD before and after Gastric Bypass Surgery'}], 'periods': [{'title': 'Before GBP', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': '6 Months After GBP', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '126 consecutive patients were assessed on site (Gastrobese Clinic) between March and October 2007, 94 met the criteria.\n\n8 patients were lost to follow-up, 4 before and 4 after GBP. Out of those, 15 were lost to follow-up and 18 refused to follow through, resulting on the actual 53 patients.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Assessed for GERD', 'description': 'Patients who had an open gastric bypass were assessed for GERD before and after surgery.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.26', 'spread': '11.56', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Patients were enrolled irrespective of GERD symptoms according to the following criteria:\n\n1. age between 18 and 70 years,\n2. BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 combined with significant comorbidities,\n3. absence of gastroesophageal surgery, and\n4. consent to undergo open GBP'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2009-08-02', 'resultsFirstSubmitDate': '2013-12-04', 'studyFirstSubmitQcDate': '2009-08-03', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-02-25', 'studyFirstPostDateStruct': {'date': '2009-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Presenting Reflux Symptoms', 'timeFrame': 'Before GBP, 6 months after GBP and 39 months after GBP', 'description': 'Prevalence of typical reflux syndrome according to the Montreal Consensus. This Consensus institutes that GERD can be outlined when troublesome symptoms and/or complications induced by reflux of the gastric content back to the esophagus are present.\n\nIn order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language was used.'}, {'measure': 'Number of Participants With Esophageal Injury', 'timeFrame': 'Before GBP, 6 months after GBP and 39 months after GBP', 'description': 'Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis'}, {'measure': 'Number of Participants With Gastroesophageal Reflux Disease (GERD)', 'timeFrame': 'Before GBP, 6 months after GBP and 39 months after GBP', 'description': 'Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.'}, {'measure': 'Total Esophageal Acid Exposure at 24h pH Monitoring', 'timeFrame': 'Before GBP, 6 months after GBP and 39 months after GBP', 'description': 'Esophageal acid exposure was measured through 24h pH monitoring. During the entire period, esophageal pH was measured and recorded as the percent of time pH was below 4.'}, {'measure': 'Esophageal Acid Exposure at 24h pH Monitoring in Upright Position', 'timeFrame': 'Before GBP, 6 months after GBP and 39 months after GBP', 'description': 'Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in upright position'}, {'measure': 'Esophageal Acid Exposure at 24h pH Monitoring in Supine Position', 'timeFrame': 'Before GBP, 6 months after GBP and 39 months after GBP', 'description': 'Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in supine position'}, {'measure': 'Number of Participants With Increased Acid Exposure', 'timeFrame': 'Before GBP, 6 months after GBP and 39 months after GBP', 'description': 'Increased Acid Exposure occurs when esophageal pH is \\<4 for a period longer than 4% of the total test time on a 24h pH monitoring.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GERD', 'Gastric bypass'], 'conditions': ['Gastroesophageal Reflux Disease', 'Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '20010088', 'type': 'DERIVED', 'citation': 'Madalosso CA, Gurski RR, Callegari-Jacques SM, Navarini D, Thiesen V, Fornari F. The impact of gastric bypass on gastroesophageal reflux disease in patients with morbid obesity: a prospective study based on the Montreal Consensus. Ann Surg. 2010 Feb;251(2):244-8. doi: 10.1097/SLA.0b013e3181bdff20.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.', 'detailedDescription': 'The investigators studied the impact of this surgical procedure on GERD in patients with morbid obesity.\n\nEsophageal syndromes were evaluated according to the Montreal Consensus, where troublesome symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for Portuguese language along with esophageal syndromes with injury assessed through upper endoscopy.\n\nEsophageal acid exposure was determined through 24h pH monitoring. Increased acid exposure was characterized when total esophageal pH \\< 4 for at least 4% of the total monitoring time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Morbid obesity\n* Acceptance to undergo open gastric bypass\n\nExclusion Criteria:\n\n* Prior gastroesophageal surgery\n* Achalasia'}, 'identificationModule': {'nctId': 'NCT00951093', 'briefTitle': 'Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Gastrobese'}, 'officialTitle': 'The Impact of Gastric Bypass on Gastroesophageal Reflux Disease in Patients With Morbid Obesity: a Prospective Study Based on Montreal Consensus', 'orgStudyIdInfo': {'id': 'GASTROBESE-004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients assessed for GERD', 'description': 'Patients who had an open gastric bypass were assessed for GERD before and after surgery following the Montreal Consensus through a validated questionnaire in Portuguese language', 'interventionNames': ['Procedure: Gastric bypass']}], 'interventions': [{'name': 'Gastric bypass', 'type': 'PROCEDURE', 'description': 'Open Silastic® ring Roux-en Y gastric bypass was performed through an upper midline incision. A gastric pouch was created by dividing the stomach with a 10-cm stapler from the lesser curvature (7 cm vertically from the cardia) to 1 cm to the left of the Hiss angle. The estimated volume of the gastric pouch was 20 to 30 ml that was banded with a 6.5 cm long Silastic® ring. A gastrojejunal anastomosis was performed with two-layers hand sewn absorbable suture over a 1.2 cm bougie distal to the ring, keeping an alimentary limb with 100 cm in length, and a biliopancreatic limb ranging 60 and 80 cm.', 'armGroupLabels': ['Patients assessed for GERD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99010112', 'city': 'Passo Fundo', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Clínica Gastrobese', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}], 'overallOfficials': [{'name': 'Carlos AS Madalosso, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica Gastrobese'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Gastrobese', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Metabolic and Bariatric Surgery', 'investigatorFullName': 'Carlos AS Madalosso', 'investigatorAffiliation': 'Clinica Gastrobese'}}}}