Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT01212835
Status:
TERMINATED
Last Update Posted:
2015-12-23
First Post:
2010-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D004941', 'term': 'Esophagitis'}], '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'}, {'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': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'whyStopped': 'lack of follow up', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-21', 'studyFirstSubmitDate': '2010-09-29', 'studyFirstSubmitQcDate': '2010-09-30', 'lastUpdatePostDateStruct': {'date': '2015-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of gastroesophageal reflux disease', 'timeFrame': 'march 2010 to march 2014', 'description': 'Patients are intra-operatively selected to receive or not a silastic ring following a open gastric bypass. These patients will be evaluated for GERD with upper endoscopy, 24h ph-monitoring, validated questionnaires which will be performed at 6 month, 1 and 2 years.'}], 'secondaryOutcomes': [{'measure': 'The role of the ring in open GBP in terms of weight loss', 'timeFrame': 'march 2010 to march 2014', 'description': 'It will be possible to evaluate the weight loss among the groups: 1) with ring and, 2) without a ring'}, {'measure': 'The impact of the ring on food tolerance', 'timeFrame': 'March 2010 to March 2014', 'description': 'To identify food intolerance among the groups: 1) with the ring, and 2) without the ring.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'gastroesophageal reflux disease', 'Morbid obesity', 'esophagitis', 'GERD', 'silastic ring', 'Gastric bypass'], 'conditions': ['Morbid Obesity', 'Gastroesophageal Reflux Disease', 'Vomiting']}, 'referencesModule': {'references': [{'pmid': '20010088', 'type': 'RESULT', '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': 'Silastic rings have been used around the gastric pouch in order to promote better weight loss after Roux-and-Y gastric bypass surgery ( RYGBP). However the investigators have shown that some patients developed gastroesophageal reflux disease after RYGBP in a previous study. The investigators hypothesized that the use of a silastic ring may play a role in promoting GERD after this operation.', 'detailedDescription': 'This is a randomized controlled double blind trial designed to identify if the use of the ring induces food intolerance and vomiting which may lead a esophageal mucosal erosions and/or GERD symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '58 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indications for bariatric surgery (BMI over 40Kg/m2 or over 35Kg/m2 associated to a life-treating morbid conditions.\n* Acceptance to be submitted to a 24h pH-monitoring and esophageal manometry\n* No contra-indication for gastric bypass\n* Absence of previous gastric surgery\n* Option for open gastric bypass\n\nExclusion Criteria:\n\n* Inferior and superior total teeth prosthesis\n* Poor surgical conditions'}, 'identificationModule': {'nctId': 'NCT01212835', 'acronym': 'RING', 'briefTitle': 'Effect of RING on Gastroesophageal Reflux (GERD) After RYGBP', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Gastrobese'}, 'officialTitle': 'The Use of a Silastic Ring in Open Gastric Bypass for Morbid Obesity and Its Association With Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': 'GASTROBESE 005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'no ring', 'description': 'Patients at this group will have RING REMOVED AT THE END OF SURGERY.', 'interventionNames': ['Procedure: Sham Comparator: no ring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RYGBP-Ring', 'description': 'Open Roux-en-Y gastric bypass with a silastic ring which is performed with linear cut stapler 100 mm and a biliopancreatic limb of 60 cm long and a alimentary limb of 100 cm long. All patients will have a 6.5 cm silastic ring located at the middle of the pouch above of the gastroenteroanastomosis.', 'interventionNames': ['Procedure: RYGBP-RING']}], 'interventions': [{'name': 'Sham Comparator: no ring', 'type': 'PROCEDURE', 'description': 'Open roux-en-Y gastric bypass not banded', 'armGroupLabels': ['no ring']}, {'name': 'RYGBP-RING', 'type': 'PROCEDURE', 'description': 'Vertical Roux-en-Y banded gastric bypass', 'armGroupLabels': ['RYGBP-Ring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99010112', 'city': 'Passo Fundo', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Clínica Gastrobese', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}, {'zip': '99020000', 'city': 'Passo Fundo', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Gastrobese Clinic', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}, {'zip': '99020000', 'city': 'Passo Fundo', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Sao Vicente de Paulo', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}], 'overallOfficials': [{'name': 'Daniel Navarini, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinica Gastrobese'}, {'name': 'Carlos AS Madalosso, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica Gastrobese'}, {'name': 'Iran Moraes Jr, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinica Gastrobese'}, {'name': 'Fabio R Barao, Admn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Protocol control'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Gastrobese', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Carlos AS Madalosso', 'investigatorFullName': 'Carlos AS Madalosso', 'investigatorAffiliation': 'Clinica Gastrobese'}}}}