Clinical Trial

FundoRing Roux-en-Y Gastric Bypass Versus FundoRing One Anastomosis Gastric Bypass

Study acronym: FundoRing_RY
Completed
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Summary
Metabolic and bariatric surgery (MBS) is an effective and durable treatment of severe obesity and its co-morbidities. Gastric bypass is one of the main MBS procedures and is performed using various surgical techniques. The main postoperative bariatric complication after one anastomosis gastric bypass (OAGB) is bile reflux, and the main disadvantage of traditional Roux-en-Y gastric bypass (RYGB) is dumping syndrome. The successful strategies for avoiding reflux esophagitis and other complication following gastric bypass is the use FundoRing method for gastric bypass with creation fundoplication employing the excluded (remnant) part of the stomach. Routine use of a modified fundoplication of the OAGB-excluded stomach to treat patients with obesity decreased acid and prevented bile reflux esophagitis significantly more effectively than standard OAGB. However, the anastomosis after OAGB is constantly bathed in bile. This was previously thought to significantly increase the risk of ulcers, but modern data shows that bile may even have a "protective" buffering effect, neutralizing acid, although the risk of alkaline gastritis remains. The results of trial of consequences of reflux bile flow from the intestine into the gastric pouch after OAGB are controversial. How does this affect the incidence of marginal ulcers due to enterogastric reflux? The answers to these questions remain unclear. The aim of the study was to compare the incidence of distal gastric pouch inflammation and the likelihood of marginal ulcers in patients treated with the FundoRing Roux-en-Y gastric bypass versus the FundoRing OAGB.
Trial Details
NCT Number NCT07486765
Lead Sponsor The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Conditions Obesity, Roux-en-y Anastomosis Site, Reflux Gastritis, Reflux Esophagitis
Enrollment 200 participants
Start Date 2024-07-04
Primary Completion 2026-03-12 (estimated)
Study Completion 2026-03-13 (estimated)
Updated on ClinicalTrials.gov 2026-03-20