一项改良的胃旁路术胃袖套旷置后胃底折叠术预防酸和胆汁反流性食管炎的随机对照试验：FundoRing 试验的 1 年结果。
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.
机构信息
Department of Surgical Disease and Bariatric Surgery, Astana Medical University, Beybitshilik Street 49A, 010000, Astana, Kazakhstan.
Surgery Center of Professor Oral Ospanov, Astana, Kazakhstan.
出版信息
Obes Surg. 2023 Jul;33(7):1974-1983. doi: 10.1007/s11695-023-06618-y. Epub 2023 Apr 26.
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/m) 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.
背景
一吻合胃旁路术（OAGB）联合胃底包裹术（“FundoRing”）治疗原发性改良抗反流术的优缺点尚不清楚。我们旨在通过随机对照试验（RCT）评估该手术的影响，并回答以下问题：（1）包裹 OAGB 中排除胃的胃底对实验组新发生反流性食管炎的保护作用有何影响？（2）术前 RE 是否可以改善实验组？（3）术前通过 PH 阻抗测量的酸反流能否通过添加“FundoRing”治疗？
方法
研究设计为单中心前瞻性、干预性、开放标签（无盲法）RCT（FundoRing 试验），随访 1 年。终点是体重指数（BMI，kg/m）和通过洛杉矶（LA）分类和 24 小时 pH 阻抗监测评估的酸和胆汁反流性食管炎。并发症按 Clavien-Dindo 分类（CDC）分级。
结果
100 例患者（n=50 FundoRingOAGB（f-OAGB）与 n=50 标准 OAGB（s-OAGB））完成了随访数据。在 OAGB 过程中，有疝的患者接受了横膈成型术（29/50 f-OAGB；24/50 s-OAGB）。两组均无漏液、出血或死亡。1 年后，f-OAGB 组 BMI 为 25.3±2.77（19-30），s-OAGB 组为 26.48±2.8（21-34）（p=0.03）。在 f-OAGB 组和 s-OAGB 组中，分别有 1 例和 12 例患者出现酸反流（p=0.001），有 0 例和 4 例患者出现胆汁反流（p<0.05）。
结论
在肥胖症患者中，常规使用改良胃底包裹 OAGB 术治疗肥胖症患者，与标准 OAGB 相比，1 年后可更有效地减少胃酸反流，并显著预防胆汁反流性食管炎。
试验注册
ClinicalTrials.gov 标识符：NCT04834635。
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