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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

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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.

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Data Availability

The datasets generated or analyzed during the current study are available from the corresponding author upon reasonable request. Requests for data should be directed to the Primary Investigator, Oral Ospanov, bariatric.kz@gmail.com.

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Acknowledgements

The authors thank all of the support personnel of the Department of Surgical Disease and Bariatric Surgery, Astana Medical University, Hospital “Green Clinic” and Surgery Center of Professor Oral Ospanov, Astana, Kazakhstan, for their hard work and dedication.

Funding

The work was supported by The Society of Bariatric and Metabolic Surgeons of Kazakhstan, Astana, Kazakhstan, Grant #2021/1. The funder had no role in the study design, data collection, data analysis, data interpretation, or writing of the manuscript.

Author information

Authors and Affiliations

  1. Department of Surgical Disease and Bariatric Surgery, Astana Medical University, Beybitshilik Street 49A, 010000, Astana, Kazakhstan

    Oral Ospanov, Galymzhan Yeleuov & Nurlan Zharov

  2. Surgery Center of Professor Oral Ospanov, Astana, Kazakhstan

    Oral Ospanov & Bakhtiyar Yelembayev

  3. Division of Scientific Research Writing, Medwrite Medical Communications, Maiden Rock, WI, USA

    J. N. Buchwald

  4. Department of Surgical Disease, South Kazakhstan Medical Academy, Shymkent, Kazakhstan

    Kassymkhan Sultanov

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  1. Oral Ospanov
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Contributions

O. O. was the principal investigator; he conceived the study. N. Z. contributed to the study design and to the development of the proposal. G. Y. led the trial methodologists. B. Y. and K. S. were involved in patient recruitment and acquisition of data. J. B. was involved in review of the scientific literature, critical substantive revision, and the post-submission revision of the manuscript. All authors approved the final version of the manuscript to be submitted.

Corresponding author

Correspondence to Oral Ospanov.

Ethics declarations

Informed Consent

Informed consent was obtained from all participants.

Ethics Approval

The study was conducted in accordance with the ethical standards of the 1964 Helsinki Declaration and its later amendments and with the approval of the regional ethics committee of Astana, Kazakhstan. The study protocol, patients’ information sheets, and informed consent forms were approved by the local ethics committee (Research Ethics Committee/Institutional Review Board [REC/IRB]): Ethics committee of SBMSK approved the trial on 29.03.2021, Approval Number: #1.

Conflict of Interest

J. N. Buchwald received a small grant for writing. All other authors declare no competing interests.

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Key Points

• Modified fundoplication of the OAGB used excluded stomach treats obesity and reflux esophagitis.

• Wrapping fundus of the excluded stomach in OAGB protected developing de novo reflux esophagitis.

• Primary fundoplication of the OAGB used excluded stomach prevented bile reflux esophagitis.

• Primary FundoRingOAGB used excluded stomach should be used routinely in each case of OAGB.

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Ospanov, O., Yeleuov, G., Buchwald, J.N. et al. 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 33, 1974–1983 (2023). https://doi.org/10.1007/s11695-023-06618-y

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