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Clinical Trial Summary

Background and study aims: Currently, one anastomosis Gastric Bypass/Mini Gastric Bypass (OAGB/MGB) is a common bariatric procedure. Obesity and gastroesophageal reflux disease are steadily increasing world weight and antireflux surgery must be performed simultaneously with bariatric surgery in obese patients. In these cases, most often, hiatus cruroraphy is performed, and less often fundoplication using the fundus of the excluded part of the stomach. We hypothesize that total fundoplication can not only treat GERD but also prevent the return of weight like a banded gastric bypass. The aim study is to compare bariatric and antireflux results after OAGB/MGB plus suture cruroplasty (SCP) with and without total fundoplication. Methods: Adult participants (n=100) are randomly allocated to one of two groups: Experimental surgical bariatric procedure in the first (A) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and suture cruroplasty (OAGB + SCP + TF group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with only suture cruroplasty (OAGB + SCP group). 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).


Clinical Trial Description

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. We hypothesize that total fundoplication can not only treat GERD but also prevent the return of weight like a banded gastric bypass. The aim study is to compare bariatric and antireflux results after OAGB/MGB plus suture cruroplasty (SCP) with and without total fundoplication. Adult participants (n=100) are randomly allocated to one of two groups: Experimental surgical bariatric procedure in the first (A) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and suture cruroplasty (OAGB + SCP + TF group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with only suture cruroplasty (OAGB + SCP group). 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04828733
Study type Interventional
Source The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Contact Oral Ospanov, Professor
Phone +77015287734
Email [email protected]
Status Recruiting
Phase N/A
Start date March 29, 2021
Completion date May 10, 2024

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