A Three-Arm Randomized Controlled Trial of Primary One-Anastomosis Gastric Bypass: With FundoRing or Nissen Fundoplications vs. without Fundoplication for the Treatment of Obesity and Gastroesophageal Reflux Disease.

Background and Objectives: Obesity and gastroesophageal reflux disease (GERD) are steadily increasing world weight and antireflux surgery must be performed simultaneously with bariatric surgery in obese patients. The purpose of this study is to compare bariatric and antireflux results after OAGB with different methods of fundoplication using the excluded stomach and without fundoplication. Materials and methods: This open-label, randomized, parallel three-arm trial was conducted from March 2019 and December 2021. All patients underwent laparoscopic one-anastomosis gastric bypass and suture cruroplasty, and then had a follow-up at 24 months. Group 1 of patients had fundoplication FundoRing using the excluded stomach (FundoRingOAGB); Group 2, with Nissen fundoplication using the excluded stomach (NissenOAGB); and Group 3, without fundoplication (OAGB). We studied changes in BMI, GERD symptoms (GERD-HRQL), and the VISICK score. Results: Of 219 participants screened, 150 were randomly allocated to 3 groups: FundoRingOAGB group (n = 50), NissenOAGB group (n = 50), and OAGB group (n = 50). At post-treatment month 24, BMI changes were as follows: from 40.7 ± 5.9 (31-53) to 24.3 ± 2.8 (19-29) kg/m2 in FundoRingOAGB group; from 39.9 ± 5.3 (32-54) to 26.3 ± 2.9 (23-32) kg/m2 in Nissen group; and from 40.9 ± 6.2 (32-56) to 28.5 ± 3.9 (25-34) kg/m2 in OAGB group. The mean pre-operative GERD-HRQL heartburn score improved post-op in FundoRingOAGB group from 20.6 ± 2.24 (19.96, 21.23) to 0.44 ± 0.73 (0.23, 0,64); in NissenOAGB group from 21.34 ± 2.43 (20.64, 22.03) to 1.14 ± 1.4 (0.74, 1.53); and in OAGB group 20.5 ± 2.17 (19.9, 21.25) to 2.12 ± 1.36 (1.73, 2.5). GERD-HRQL total scores were from pre-op 25.2 ± 2.7 (24.4, 25.9) to 4.34 ± 1.3 (3.96, 4.7) post-op in FundoRingOAGB group; 24.8 ± 2.93 (24, 25.67) pre-op to 5.42 ± 1.7 (4.9, 5.9) in the NissenOAGB group; and from 21.46 ± 2.7 (20.7, 22.2) to 7.44 ± 2.7 (6.6, 8.2) in the OAGB group. The mean VISICK score improved from 3.64 ± 0.94 (3.7, 3.9) to 1.48 ± 1.26 (1.12, 1.84) in FundoRingOAGB, from 3.42 ± 0.97 (3.1, 3,7) to 2.5 ± 1.46 (2.06, 2.9) in NissenOAGB group and from 3.38 ± 0.88 (3.1, 3,69) to 2.96 ± 1.19 (2.62, 3.2) in OAGB group. Conclusions: Antireflux and bariatric results of FundoRingOAGB are better than using the NissenOAGB method and significantly better than OAGB without the use of fundoplication.

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.

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.