Top

Obesity Surgery

Published in:

26-04-2023 | Obesity | Original Contributions

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

Authors: Oral Ospanov, Galymzhan Yeleuov, J. N. Buchwald, Nurlan Zharov, Bakhtiyar Yelembayev, Kassymkhan Sultanov

Published in: Obesity Surgery | Issue 7/2023

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.

Graphical Abstract

Robert M, Espalieu P, Pelascini E, Caiazzo R, Sterkers A, Khamphommala L, et al. Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity (YOMEGA): a multicentre, randomised, open-label, non-inferiority trial. Lancet. 2019;393(10178):1299–309. https://doi.org/10.1016/S0140-6736(19)30475-1.CrossRefPubMed

Tolone S, Cristiano S, Savarino E, Lucido FS, Fico DI, Docimo L. Effects of omega-loop bypass on esophagogastric junction function. Surg Obes Relat Dis. 2016;12(1):62–9. https://doi.org/10.1016/j.soard.2015.03.011.CrossRefPubMed

Nehmeh WA, Baratte C, Rives-Lange C, Martineau C, Boullenois H, Krivan S, et al. Acid reflux is common in patients with gastroesophageal reflux disease after one-anastomosis gastric bypass. Obes Surg. 2021;31(11):4717–23. https://doi.org/10.1007/s11695-021-05542-3.CrossRefPubMed

Kassir R, Petrucciani N, Debs T, Juglard G, Martini F, Liagre A. Conversion of one anastomosis gastric bypass (OAGB) to Roux-en-Y gastric bypass (RYGB) for biliary reflux resistant to medical treatment: lessons learned from a retrospective series of 2780 consecutive patients undergoing OAGB. Obes Surg. 2020;30(6):2093–8. https://doi.org/10.1007/s11695-020-04460-0.CrossRefPubMed

De Luca M, Piatto G, Merola G, Himpens J, Chevallier JM, Carbajo MA, et al. IFSO updated position statement on one anastomosis gastric bypass (OAGB). Obes Surg. 2021;31(7):3251–78. https://doi.org/10.1007/s11695-021-05413-x.CrossRefPubMed

Keleidari B, Mahmoudieh M, DavarpanahJazi AH, Melali H, Nasr Esfahani F, et al. Comparison of the bile reflux frequency in one anastomosis gastric bypass and Roux-en-Y gastric bypass: a cohort study. Obes Surg. 2019;29:1721–5. https://doi.org/10.1007/s11695-018-03683-6.CrossRefPubMed

Colpaert J, Horevoets J, Maes L, Uijtterhaegen G, Dillemans D. Surgical treatment of therapy-resistant reflux after Roux-en-Y gastric bypass: a case series of the modified Nissen fundoplication. Acta Chir Belg. 2020;120(4):291–6. https://doi.org/10.1080/00015458.2019.1696028.CrossRefPubMed

Ospanov O, Yeleuov G, Fursov A, Yelembayev B, Fursov R, Sergazin Z, Mustafin A. A laparoscopic one anastomosis gastric bypass with wrapping versus nonwrapping fundus of the excluded part of the stomach to treat obese patients (FundoRingOAGB trial): study protocol for a randomized controlled trial. Trials. 2022;23(1):264. https://doi.org/10.1186/s13063-022-06252-6.CrossRefPubMedPubMedCentral

Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010;1:100–7.CrossRefPubMedPubMedCentral

10.

Brasher PM, Brant RF. Sample size calculations in randomized trials: common pitfalls. Can J Anaesth. 2007;54:103–6.CrossRefPubMed

11.

Han MS, Lada MJ, Nieman DR, Tschoner A, Peyre CG, Jones CE, Watson TJ, Peters JH. 24-h multichannel intraluminal impedance-pH monitoring may be an inadequate test for detecting gastroesophageal reflux in patients with mixed typical and atypical symptoms. Surg Endosc. 2015;29:1700–8. https://doi.org/10.1007/s00464-014-3867-1.CrossRefPubMed

12.

Ospanov O. The surgical technique of primary modified fundoplication using the excluded stomach with simultaneous gastric bypass. OBES SURG. 2023;33:1311–3. https://doi.org/10.1007/s11695-023-06505-6.CrossRefPubMed

13.

Carbajo MA, Luque-de-León E, Jiménez JM, Ortiz-de-Solórzano J, Pérez-Miranda M, Castro-Alija MJ. Laparoscopic one-anastomosis gastric bypass: technique, results, and long-term follow-up in 1200 patients. Obes Surg. 2017;27(5):1153–67.CrossRefPubMed

14.

Chan DL, Wong SK, Lok HT, Iliopoulos J, Talbot ML, Hennessy A, Ng EK. Accuracy of hiatal hernia diagnosis in bariatric patients: preoperative endoscopy versus intraoperative reference. JGH Open. 2020;4(6):1074–8. https://doi.org/10.1002/jgh3.12388.CrossRefPubMedPubMedCentral

15.

Lundell LR, Dent J, Bennett JR, Blum AL, Armstrong D, Galmiche JP, et al. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999;45(2):172–80. https://doi.org/10.1136/gut.45.2.172.CrossRefPubMedPubMedCentral

16.

García-García ML, Martín-Lorenzo JG, Lirón-Ruiz R, Torralba-Martínez JA, García-López JA, Aguayo-Albasini JL. Perioperative complications following bariatric surgery according to the Clavien-Dindo classification. Score validation, literature review and results in a single-centre series. Surg Obes Relat Dis. 2017;13(9):1555–61. https://doi.org/10.1016/j.soard.2017.04.018.CrossRefPubMed

17.

Neto RML, Herbella FAM, Schlottmann F, Patti MG. Does DeMeester score still define GERD? Dis Esophagus. 2019;32(5):doy118. https://doi.org/10.1093/dote/doy118.CrossRefPubMed

18.

Angrisani L, Santonicola A, Iovino P, Vitiello A, Higa K, Himpens J, et al. IFSO Worldwide Survey 2016: primary, endoluminal, and revisional procedures. Obes Surg. 2018;28(12):3783–94.CrossRefPubMed

19.

De Luca M, Piatto G, Merola G, Himpens J, Chevallier JM, Carbajo MA, et al. IFSO update position statement on one anastomosis gastric bypass (OAGB). Obes Surg. 2021;31(7):3251–78. https://doi.org/10.1007/s11695-021-05413-x.CrossRefPubMed

20.

Poghosyan T, Krivan S, Baratte C. Bile or acid reflux post one-anastomosis gastric bypass: what must we do? Still an unsolved enigma. J Clin Med. 2022;11(12):3346. https://doi.org/10.3390/jcm11123346.CrossRefPubMedPubMedCentral

21.

Chen RH, Lautz D, Gilbert RJ, Bueno R. Antireflux operation for gastroesophageal reflux after Roux-en-Y gastric bypass for obesity. Ann Thorac Surg. 2005;80(5):1938–40. https://doi.org/10.1016/j.athoracsur.2004.06.019.CrossRefPubMed

22.

Liakakos T, Karamanolis G, Patapis P, Misiakos EP. Gastroesophageal reflux disease: medical or surgical treatment? Gastroenterol Res Pract. 2009;2009:371580. https://doi.org/10.1155/2009/371580.CrossRefPubMedPubMedCentral

23.

Dallemagne B, Weerts J, Markiewicz S, Dewandre JM, Wahlen C, Monami B, Jehaes C. Clinical results of laparoscopic fundoplication at ten years after surgery. Surg Endosc. 2006;20:159–65.CrossRefPubMed

24.

Dallemagne B, Perretta S. Twenty years of laparoscopic fundoplication for GERD. World J Surg. 2011;35:1428–35.CrossRefPubMed

25.

Mardani J, Lundell L, Engström C. Total or posterior partial fundoplication in the treatment of GERD: results of a randomized trial after 2 decades of follow-up. Ann Surg. 2011;253:875–8.CrossRefPubMed

26.

Soprani A, Carandina S, El Kareh I, Genser L, Cady J. Revision of lap-band to MGB. In: Deitel M. (eds) Essentials of mini ‒ one anastomosis gastric bypass. Springer, Cham. 2018: https://doi.org/10.1007/978-3-319-76177-0_22.

27.

Ospanov OB. The gastric bypass and fundoplication in bariatric surgery: the comments on published papers and our classification of combination procedures. Obes Surg. 2021;31:4643–4. https://doi.org/10.1007/s11695-021-05505-8.CrossRefPubMed

28.

Sheikh L, Pearless LA, Booth MW. Laparoscopic silastic ring mini-gastric bypass (SR-MGBP): up to 11 year results from a single centre. Obes Surg. 2017;27(9):2229–34. https://doi.org/10.1007/s11695-017-2659-9.CrossRefPubMed

29.

Cazzo E, Jimenez LS, Valerini FG, de Freitas Diniz TB, Ramos AC, Chaim EA. Weight loss and vomiting 1 year after banded versus non-banded one anastomosis gastric bypass: a prospective randomized trial. Obes Surg. 2020;30(5):1719–25. https://doi.org/10.1007/s11695-020-04393-8.CrossRefPubMed

30.

Miller KA, Radauer M, Buchwald JN, McGlennon TW, Ardelt-Gattinger E. 5-year results of banded one-anastomosis gastric bypass: a pilot study in super-obese patients. Obes Surg. 2020;30(11):4307–14.CrossRefPubMed

31.

Kral J, Selucka J, Dolecek F, Waloszkova K, Buzga M, Spicak J, Machytka E. Endoscopic extraction of migrated gastric bypass Fobi ring in patient after gastric bypass. Endoscopy. 2022;54(S 02):E1030–1. https://doi.org/10.1055/a-1903-1450.CrossRefPubMedPubMedCentral

32.

Ospanov O, Nadirov K, Koikov V, Zharov N. One anastomosis gastric bypass with fundoplication of remnant stomach for weight regain prevention: case report. Int J Surg Case Rep. 2022;20(97):107431. https://doi.org/10.1016/j.ijscr.2022.107431.CrossRef

Title: 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
Authors: Oral Ospanov
Galymzhan Yeleuov
J. N. Buchwald
Nurlan Zharov
Bakhtiyar Yelembayev
Kassymkhan Sultanov
Publication date: 26-04-2023
Publisher: Springer US
Keywords: Obesity
Obesity
Bariatric Surgery
Bariatric Surgery
Esophagitis
Gastroesophageal Reflux Disease
Gastric Fundoplication
Gastric Fundoplication
Published in: Obesity Surgery / Issue 7/2023
Print ISSN: 0960-8923
Electronic ISSN: 1708-0428
DOI: https://doi.org/10.1007/s11695-023-06618-y

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusion

Trial Registration

Graphical Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

Trial Registration

Graphical Abstract

Please log in to get access to this content

Other articles of this Issue 7/2023

Robotic-Assisted Bariatric Surgery Is Associated with Increased Postoperative Complications Compared to Laparoscopic: a Nationwide Readmissions Database Study

Identifying Workflow Disruptions in Robotic-Assisted Bariatric Surgery: Elucidating Challenges Experienced by Surgical Teams

Correction: Severe Cannabis use is Associated with Complications and Prolonged Length of Stay in Bariatric Surgery

Bariatric Surgery Performed at a Tertiary Care Hospital and an Ambulatory Hospital: A 5 Year Comparison of Outcomes, OR Efficiencies and Costs

Seamguard Buttressing of the Staple Line During Laparoscopic Sleeve Gastrectomy Appears to Decrease the Incidence of Postoperative Bleeding, Leaks, and Reoperations. A Systematic Review and Meta-Analysis of Non-Randomized Comparative Studies

Mesenteric Defect Closure and the Rate of Internal Hernia in Laparoscopic Roux-en-Y Gastric Bypass: A Systematic Review and Meta-analysis