A Randomized Controlled Trial of Acid and Bile Reflux Esophagitis Prevention by Modified Fundoplication of the Excluded Stomach in One-Anastomosis Gastric Bypass: 1-Year Results of the FundoRing Trial

Oral Ospanov; Galymzhan Yeleuov; J N Buchwald; Nurlan Zharov; Bakhtiyar Yelembayev; Kassymkhan Sultanov

doi:10.1007/s11695-023-06618-y

A Randomized Controlled Trial of Acid and Bile Reflux Esophagitis Prevention by Modified Fundoplication of the Excluded Stomach in One-Anastomosis Gastric Bypass: 1-Year Results of the FundoRing Trial

Obes Surg. 2023 Jul;33(7):1974-1983. doi: 10.1007/s11695-023-06618-y. Epub 2023 Apr 26.

Authors

Oral Ospanov^{1

2}, Galymzhan Yeleuov³, J N Buchwald⁴, Nurlan Zharov³, Bakhtiyar Yelembayev⁵, Kassymkhan Sultanov⁶

Affiliations

¹ Department of Surgical Disease and Bariatric Surgery, Astana Medical University, Beybitshilik Street 49A, 010000, Astana, Kazakhstan. bariatric.kz@gmail.com.
² Surgery Center of Professor Oral Ospanov, Astana, Kazakhstan. bariatric.kz@gmail.com.
³ Department of Surgical Disease and Bariatric Surgery, Astana Medical University, Beybitshilik Street 49A, 010000, Astana, Kazakhstan.
⁴ Division of Scientific Research Writing, Medwrite Medical Communications, Maiden Rock, WI, USA.
⁵ Surgery Center of Professor Oral Ospanov, Astana, Kazakhstan.
⁶ Department of Surgical Disease, South Kazakhstan Medical Academy, Shymkent, Kazakhstan.

PMID: 37099252
DOI: 10.1007/s11695-023-06618-y

Abstract

Background: The advantages and disadvantages of one-anastomosis gastric bypass (OAGB) with primary modified fundoplication using the excluded stomach ("FundoRing") is unclear. We aimed to assess the impact of this operation in a randomized controlled trial (RCT) and answer the next questions: (1) What the impact of wrapping the fundus of the excluded part of the stomach in OAGB on protection in the experimental group against developing de novo reflux esophagitis? (2) If preoperative RE could be improved in the experimental group? (3) Can preoperative acid reflux as measured by PH impedance, be treated by the addition of the "FundoRing"?

Methods: The study design was a single-center prospective, interventional, open-label (no masking) RCT (FundoRing Trial) with 1-year follow-up. Endpoints were body mass index (BMI, kg/m²) and acid and bile RE assessed endoscopically by Los Angeles (LA) classification and 24-h pH impedance monitoring. Complications were graded by Clavien-Dindo classification (CDC).

Results: One hundred patients (n = 50 FundoRingOAGB (f-OAGB) vs n = 50 standard OAGB (s-OAGB)) with complete follow-up data were included in the study. During OAGB procedures, patients with hiatal hernia underwent cruroplasty (29/50 f-OAGB; 24/50 s-OAGB). There were no leaks, bleeding, or deaths in either group. At 1 year, BMI in the f-OAGB group was 25.3 ± 2.77 (19-30) vs 26.48 ± 2.8 (21-34) s-OAGB group (p = 0.03). In f-OAGB vs s-OAGB groups, respectively, acid RE was seen in 1 vs 12 patients (p = 0.001) and bile RE in 0 vs 4 patients (p < 0.05).

Conclusion: 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 at 1 year in a randomized controlled trial.

Trial registration: ClinicalTrials.gov Identifier: NCT04834635.

Keywords: Acid and bile reflux esophagitis; Bariatric surgery; FundoRingOAGB; Fundoplication; Modified fundoplication of the OAGB-excluded stomach; Obesity; One-anastomosis gastric bypass.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Bile
Bile Reflux* / etiology
Bile Reflux* / prevention & control
Esophagitis, Peptic* / complications
Esophagitis, Peptic* / prevention & control
Fundoplication / adverse effects
Gastric Bypass* / methods
Humans
Obesity, Morbid* / surgery
Retrospective Studies

Associated data

ClinicalTrials.gov/NCT04834635