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

Oral Ospanov, Galymzhan Yeleuov, Alexandr Fursov, Bakhtiyar Yelembayev, Roman Fursov, Zhenis Sergazin, Adil Mustafin, Oral Ospanov, Galymzhan Yeleuov, Alexandr Fursov, Bakhtiyar Yelembayev, Roman Fursov, Zhenis Sergazin, Adil Mustafin

Abstract

Background: Laparoscopic one anastomosis gastric bypass (LOAGB) is a simple variation of gastric bypass and has gained worldwide popularity with clinical outcomes similar to laparoscopic Roux-en-Y gastric bypass (LRYGB) for weight loss and management of comorbidities. However, biliary reflux to the esophagus negates the benefits of LOAGB. In addition, weight gain after LOAGB and after LRYGB is a major problem in bariatric surgery. The aim of this article is to describe the design and protocol of a randomized controlled trial comparing the outcomes of two methods of LOAGB: experimental method with wrapping versus standard method nonwrapping fundus of the excluded part of the stomach to prevent weight regain and biliary reflux after LOAGB.

Methods: The study was designed as a single-center prospective, interventional, randomized controlled trial. Masking: None (open label). Allocation: randomized. Enrollment: 100 obese patients. The relevant ethics committee approved the trial protocol. The endpoints (body mass index, bile reflux in the esophagus, other reflux symptoms) will be assessed presurgery and postsurgery (12, 24, and 36 months postoperatively).

Discussion: With its 3-year follow-up time, this RCT will provide important data on the impact of wrapping the fundus of the excluded part of the stomach to prevent weight regain and biliary reflux after LOAGB.

Trial registration: ClinicalTrials.gov NCT04834635 . Registered on 8 April 2021.

Keywords: FundoRingMGB; FundoRingOAGB; Fundoplication; Gastroesophageal reflux disease; Minigastric bypass; Morbid obesity; One anastomosis gastric bypass.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
FundoRing OA(M)GB - Laparoscopic anastomosis (mini) gastric bypass with total wrapping of the fundus of the gastric excluded part and suture cruroplasty.© 2021 Oral Ospanov
Fig. 2
Fig. 2
Laparoscopic one anastomosis (mini) gastric bypass was performed by Carbajo MA© 2021 Oral Ospanov

References

    1. Golzarand M, Toolabi K, Farid R. The bariatric surgery and weight losing: a meta-analysis in the long- and very long-term effects of laparoscopic adjustable gastric banding, laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy on weight loss in adults. Surg Endosc. 2017;31(11):4331–4345. doi: 10.1007/s00464-017-5505-1.
    1. Faria SL, de Oliveira Kelly E, Lins RD, Faria OP. Nutritional Management of Weight Regain After Bariatric Surgery. Obes Surg. 2010;20(2):135–139. doi: 10.1007/s11695-008-9610-z.
    1. Fobi M, Malgorzata V, Stanczyk JN, Che-Senge K. The banded gastric bypass: principles of metabolic surgery III. Springer; 2012. pp. 227–238.
    1. Spann MD, Aher C. V, English W.J., Williams D.B. Endoscopic management of erosion after banded bariatric procedures. Surg Obes Relat Dis. 2017;13(11):1875–1879. doi: 10.1016/j.soard.2017.07.025.
    1. Deitel M. International MGB-OAGB Club affiliates with IJS. Int. J. Surg. 2019;61:76–77. doi: 10.1016/j.ijsu.2018.09.008.
    1. De Luca M, Piatto G, Merola G, et al. IFSO Update Position Statement on One Anastomosis Gastric Bypass (OAGB) Obes Surg. 2021;31(7):3251–3278. doi: 10.1007/s11695-021-05413-x.
    1. 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):2093–2098. doi: 10.1007/s11695-020-04460-0.
    1. Ospanov O, Maleckas A, Orekeshova A. Gastric greater curvature plication combined with Nissen fundoplication in the treatment of gastroesophageal reflux disease and obesity. Medicina. 2016;52(5):283–290. doi: 10.1016/j.medici.2016.08.001.
    1. Kawahara NT, Alster C, Maluf-Filho F, Polara W, Campos GM, Poli-de-Figueiredo LF. Modified Nissen fundoplication: laparoscopic antireflux surgery after Roux-en-Y gastric bypass for obesity. Clinics (Sao Paulo). 2012;67(5):531–533. doi: 10.6061/clinics/2012(05)23.
    1. Colpaert J, Horevoets J, Maes L, Uijtterhaegen G, Dillemans B. 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):291–296. doi: 10.1080/00015458.2019.1696028.
    1. Maurissen J, Yercovich N, Van Aelst P, et al. Modified Nissen Fundoplication for Late Dumping Syndrome After Roux-en-Y Gastric Bypass. Obes Surg. 2021;31(5):2353–2355. doi: 10.1007/s11695-021-05310-3.
    1. 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):1153–1167. doi: 10.1007/s11695-016-2428-1.
    1. 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(10):4643–4644. doi: 10.1007/s11695-021-05505-8.
    1. Bhandari M, Fobi MAL, Buchwald JN, et al. Standardization of Bariatric Metabolic Procedures: World Consensus Meeting Statement. Obes Surg. 2019;29(S4):309–345. doi: 10.1007/s11695-019-04032-x.
    1. Ospanov O, Buchwald JN, Yeleuov G, Bekmurzinova F. Laparoscopic One-Anastomosis Gastric Bypass with Band-Separated Gastric Pouch (OAGB-BSGP): a Randomized Controlled Trial. Obes Surg. 2019;29(12):4131–4137. doi: 10.1007/s11695-019-04236-1.
    1. Brasher PM, Brant RF. Sample size calculations in randomized trials: common pitfalls. Can J Anaesth. 2007;54(2):103–106. doi: 10.1007/BF03022005.
    1. Ospanov O. Thank IFSO for the Support that Allowed to Include the Specialization “Bariatric and Metabolic Surgery” in the Healthcare System of Kazakhstan. Obes Surg. 2021;31(6):2774–2775. doi: 10.1007/s11695-021-05232-0.
    1. Robert M, Espalieu P, Pelascini E, Caiazzo R, Sterkers A, Khamphommala L, Poghosyan T, Chevallier JM, Malherbe V, Chouillard E, Reche F, Torcivia A, Maucort-Boulch D, Bin-Dorel S, Langlois-Jacques C, Delaunay D, Pattou F, Disse E. 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):1298. doi: 10.1016/S0140-6736(19)30475-1. Epub 2019 Mar 6. Erratum in: Lancet. 2019;393(10178):1298.
    1. Soprani A, Carandina S, El Kareh I, Genser L, Cady J. Revision of Lap-Band to MGB. In: Deitel M, editor. Essentials of Mini – One Anastomosis Gastric Bypass. Cham: Springer; 2018.
    1. Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130–134. doi: 10.1111/j.1442-2050.2007.00658.x.
    1. Ospanov O. Biography: Oral Ospanov, M.D., PhD, DMedSc, Professor. Obes Surg. 2021;31(7):2849–2850. doi: 10.1007/s11695-021-05501-y.

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