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

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.

Conditions

• Obesity
• Roux-en-y Anastomosis Site
• Reflux Gastritis
• Reflux Esophagitis

Interventions

PROCEDURE

Laparoscopic FundoRing gastric bypass

Laparoscopic gastric bypass is a minimally invasive weight loss surgery that reduces the stomach's volume to 20 ml (separated stomach to gastric pouch (small part) and remnant (excluded, large) part) and reroutes the small intestine from the gastric pouch, bypassing the duodenum, into the jejunum, limiting food intake and reducing calorie absorption. Additionally, the esophagus and the upper part of the gastric pouch were wrapped with the upper part (fundus) of the excluded (remnant) part of stomach using the FundoRing method.

Sponsors & Collaborators

• The Society of Bariatric and Metabolic Surgeons of Kazakhstan

  lead OTHER

Principal Investigators

• Oral Ospanov, Professor · The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-04

Primary Completion

2026-03-12

Completion

2026-03-13

Countries

• Kazakhstan