One Anastomosis Gastric Bypass With Excluded Stomach Fundoplication: FundoRing vs Nissen vs OAGB Without Fundoplication
NCT ID: NCT04828733
Last Updated: 2025-01-03
Study Results
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Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2019-03-29
2024-05-10
Brief Summary
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Currently, one anastomosis Gastric Bypass (OAGB) is a common bariatric procedure.
Obesity 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.
The 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.
The main questions it aims to answer are:
* 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?
* What is the impact of excluded stomach fundoplication on weight loss in FundoRing group versus standard Nissen group in OAGB?
Methods: Adult participants (n=150) are randomly allocated to one of three groups:
Experimental 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).
Active 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).
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Detailed Description
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The 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.
Adult participants (n=150) are randomly allocated to one of three groups:
Experimental 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).
Active 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OAGB + SCP + FundoRing
laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty
laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty
Laparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use FundoRing method.
OAGB + SCP + NF
laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty
laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty
Laparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use the Nissen method.
OAGB + SCP
laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty
Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.
Laparoscopic gastric bypass with only suture cruroplasty without fundoplication
Interventions
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laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty
Laparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use FundoRing method.
laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty
Laparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use the Nissen method.
Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.
Laparoscopic gastric bypass with only suture cruroplasty without fundoplication
Eligibility Criteria
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Inclusion Criteria
* Patients with GERD A or B grade of reflux esophagitis (LA grade) after treatment PPI
* Hiatal hernia (HH) \<5 cm
* ASA grading 1-2
* Age 18-60 years old.
Exclusion Criteria
* Esophageal shortening
* Patients with C or D grade of RE (reflux esophagitis)
* Previously surgery on the stomach or esophagus
* Psychiatric illness
18 Years
60 Years
ALL
No
Sponsors
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The Society of Bariatric and Metabolic Surgeons of Kazakhstan
OTHER
Responsible Party
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Principal Investigators
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Oral Ospanov, Professor
Role: PRINCIPAL_INVESTIGATOR
President of Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK)
Locations
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Oral Ospanov
Astana, , Kazakhstan
Countries
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References
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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.
Other Identifiers
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FundoRing vs Nissen
Identifier Type: -
Identifier Source: org_study_id
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