Key result
FundoRing undergoes evaluation versus standard OAGB for BMI reduction and comorbidity remission.
Why the study?
Conventional one-anastomosis gastric bypass is often complicated by weight regain, gastroesophageal reflux, and dumping syndrome, prompting the need for modifications that enhance weight control and reduce reflux without synthetic band risks.
Does the FundoRing modification of one-anastomosis gastric bypass improve weight loss, comorbidity remission, and quality of life compared to standard gastric bypass in patients with obesity and metabolic syndrome?
RCT (n=1,000)
Open-label
Random allocation sequence
No
Does the FundoRing modification of one-anastomosis gastric bypass improve weight loss, comorbidity remission, and quality of life compared to standard gastric bypass in patients with obesity and metabolic syndrome?
This study protocol describes a randomized controlled trial to evaluate whether the novel FundoRing modification of one-anastomosis gastric bypass improves long-term weight loss and reduces reflux compared to standard bypass in patients with obesity and metabolic syndrome.
<ns3:p> Obesity and metabolic syndrome remain major global health challenges, with bariatric surgery being the most effective treatment in cases of severe obesity. Despite satisfactory outcomes, conventional one-anastomosis gastric bypass (OAGB) is often complicated by weight regain, gastroesophageal reflux, and dumping syndrome. To address these issues, we developed a modified approach—FundoRing OAGB—which employs the patient’s own gastric fundus to create an autologous restrictive wrap, thereby enhancing weight control and reducing reflux without the risks associated with synthetic gastric band. This single-center, randomized controlled trial enrolled 1000 patients with body mass index (BMI) 30–50 kg/m <ns3:sup>2</ns3:sup> , allocated into two groups: the experimental group underwent OAGB with the FundoRing modification and hiatal repair when indicated, while the control group underwent standard OAGB. Patients will be followed for up to 60 months. Primary outcomes include changes in BMI, remission of comorbidities, and quality of life improvement. Secondary endpoints assess reflux parameters, gastric pouch dilation, intraoperative perfusion imaging, and cost-effectiveness. The FundoRing technique offers a physiologic, autologous alternative to conventional banding methods, aiming to strengthen the restrictive effect of OAGB while minimizing complications. Results from this large-scale trial are expected to clarify the role of FundoRing OAGB in optimizing long-term bariatric and metabolic outcomes. Trial registration: ClinicalTrials.gov Identifier: NCT04834635. Trial registration: ClinicalTrials.gov ID NCT04834635. Registered on 04 april 2021. </ns3:p>
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Оспанов et al. (2025) conducted an RCT in Metabolic syndrome and obesity (n=1,000). FundoRing one-anastomosis gastric bypass vs. Standard one-anastomosis gastric bypass was evaluated on Changes in body mass index (Δ-BMI), changes in concomitant diseases, and changes in quality of life. FundoRing one-anastomosis gastric bypass is being evaluated in a 1000-patient randomized controlled trial to determine its effect on BMI and comorbidity remission compared to standard OAGB.
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