Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-02-27 @ 10:04 AM
Study NCT ID:
NCT04828733
Status:
COMPLETED
Last Update Posted:
2025-01-03
First Post:
2021-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One Anastomosis Gastric Bypass With Excluded Stomach Fundoplication: FundoRing vs Nissen vs OAGB Without Fundoplication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-01', 'studyFirstSubmitDate': '2021-03-30', 'studyFirstSubmitQcDate': '2021-03-30', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of body mass index', 'timeFrame': 'Baseline, at 12, 24, 36 months after surgery', 'description': 'The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2.'}, {'measure': 'Change of GERD symptoms (GERD-HRQL)', 'timeFrame': '12, 24, 36 months after surgery', 'description': 'Success; ≥50% improvement in the baseline GERD-HRQL score Failure; \\<50% improvement in the baseline GERD-HRQL score at 12,24, 36 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'GERD', 'Gastric bypass', 'Fundoplication', 'Nissen', 'FundoRing'], 'conditions': ['Obesity', 'GERD']}, 'referencesModule': {'references': [{'pmid': '38541131', 'type': 'RESULT', 'citation': 'Ospanov O, Zharov N, Yelembayev B, Duysenov G, Volchkova I, Sultanov K, Mustafin A. A Three-Arm Randomized Controlled Trial of Primary One-Anastomosis Gastric Bypass: With FundoRing or Nissen Fundoplications vs. without Fundoplication for the Treatment of Obesity and Gastroesophageal Reflux Disease. Medicina (Kaunas). 2024 Feb 27;60(3):405. doi: 10.3390/medicina60030405.'}]}, 'descriptionModule': {'briefSummary': 'Background and study aims:\n\nCurrently, one anastomosis Gastric Bypass (OAGB) is a common bariatric procedure.\n\nObesity and gastroesophageal reflux disease (GERD) are steadily increasing world weight and antireflux surgery must be performed simultaneously with bariatric surgery in obese patients. In these cases, most often for GERD patients OAGB procedures only with hiatus cruroraphy is performed.\n\nThe goal of this randomized controlled clinical trial is to compare bariatric and antireflux results after OAGB plus suture cruroplasty with FundoRing (n=50) versus Nissen fundoplication (n=50) and versus without total fundoplication (n=50) for patients with morbid obesity and GERD.\n\nThe main questions it aims to answer are:\n\n* What is the impact of wrapping the fundus of the excluded part of the stomach use FundoRing method in the experimental group against developing reflux esophagitis compare impact standard Nissen in OAGB?\n* What is the impact of excluded stomach fundoplication on weight loss in FundoRing group versus standard Nissen group in OAGB?\n\nMethods: Adult participants (n=150) are randomly allocated to one of three groups:\n\nExperimental surgical bariatric procedure in the first (A) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty (OAGB + SCP + FundoRing); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty (OAGB + SCP +NF).\n\nActive comparator surgical bariatric procedure in the second (C) group: patients (n=50) undergo laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty (OAGB + SCP). All patients are then followed up 12, 24, and 36 months after surgery where the changing body mass index and change of GERD symptoms (GERD-HRQL).', 'detailedDescription': 'One anastomosis Gastric Bypass/Mini Gastric Bypass (OAGB/MGB) is gaining popularity as a primary surgical treatment for morbid obesity. The total fundoplication is the gold standard for treating GERD. Morbid obesity and GERD require simultaneous surgical treatment.\n\nThe aim study is to compare bariatric and antireflux results after OAGB/MGB plus suture cruroplasty (SCP) with FundoRing versus Nissen fundoplication and versus without total fundoplication.\n\nAdult participants (n=150) are randomly allocated to one of three groups:\n\nExperimental surgical bariatric procedure in the first (A) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty (OAGB + SCP + FundoRing); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty (OAGB + SCP +NF).\n\nActive comparator surgical bariatric procedure in the second (C) group: patients (n=50) undergo laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty (OAGB + SCP). All patients are then followed up 12, 24, 36 months after surgery where record the changing body mass index and change of GERD symptoms (GERD-HRQL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Class I- III obesity (BMI 30.0-50.0 kg/m)\n* Patients with GERD A or B grade of reflux esophagitis (LA grade) after treatment PPI\n* Hiatal hernia (HH) \\<5 cm\n* ASA grading 1-2\n* Age 18-60 years old.\n\nExclusion Criteria:\n\n* Giant hiatal hernia (HH) \\>5 cm\n* Esophageal shortening\n* Patients with C or D grade of RE (reflux esophagitis)\n* Previously surgery on the stomach or esophagus\n* Psychiatric illness'}, 'identificationModule': {'nctId': 'NCT04828733', 'acronym': 'FundoRing', 'briefTitle': 'One Anastomosis Gastric Bypass With Excluded Stomach Fundoplication: FundoRing vs Nissen vs OAGB Without Fundoplication', 'organization': {'class': 'OTHER', 'fullName': 'The Society of Bariatric and Metabolic Surgeons of Kazakhstan'}, 'officialTitle': 'A Randomized Controlled Trial of Laparoscopic One Anastomosis Gastric Bypass With Excluded Stomach Fundoplication: FundoRingOAGB Versus NissenOAGB Versus OAGB Without Fundoplication for Treating Morbid Obesity and GERD', 'orgStudyIdInfo': {'id': 'FundoRing vs Nissen'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OAGB + SCP + FundoRing', 'description': 'laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty', 'interventionNames': ['Procedure: laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OAGB + SCP + NF', 'description': 'laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty', 'interventionNames': ['Procedure: laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OAGB + SCP', 'description': 'laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty', 'interventionNames': ['Procedure: Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.']}], 'interventions': [{'name': 'laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty', 'type': 'PROCEDURE', 'description': 'Laparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use FundoRing method.', 'armGroupLabels': ['OAGB + SCP + FundoRing']}, {'name': 'laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty', 'type': 'PROCEDURE', 'description': 'Laparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use the Nissen method.', 'armGroupLabels': ['OAGB + SCP + NF']}, {'name': 'Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.', 'type': 'PROCEDURE', 'description': 'Laparoscopic gastric bypass with only suture cruroplasty without fundoplication', 'armGroupLabels': ['OAGB + SCP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '020000', 'city': 'Astana', 'country': 'Kazakhstan', 'facility': 'Oral Ospanov', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}], 'overallOfficials': [{'name': 'Oral Ospanov, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'President of Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Society of Bariatric and Metabolic Surgeons of Kazakhstan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}