背景和目的:肥胖和胃食管反流病(GERD)正在稳步增加世界体重,肥胖患者必须在减重手术的同时进行抗反流手术。这项研究的目的是比较OAGB使用不同的胃底折叠术方法后的减肥和抗反流结果。材料和方法:这种开放标签,随机化,平行三臂试验于2019年3月和2021年12月进行.所有患者均行腹腔镜下一次吻合术胃旁路术和缝合术,然后在24个月时进行了随访。第1组患者使用排除的胃进行胃底折叠术(FundoRingOAGB);第2组,使用排除的胃进行尼森胃底折叠术(NissenOAGB);第3组,没有胃底折叠术(OAGB)。我们研究了BMI的变化,GERD症状(GERD-HRQL),和VISICK得分。结果:在接受筛查的219名参与者中,150人随机分为3组:FundoRingOAGB组(n=50),NissenOAGB组(n=50),和OAGB组(n=50)。治疗后第24个月,BMI变化如下:FundoRingOAGB组从40.7±5.9(31-53)到24.3±2.8(19-29)kg/m2;Nissen组从39.9±5.3(32-54)到26.3±2.9(23-32)kg/m2;GB组从40.9±6.2(32-56)到28.5±3.9(25-34)kg/m2。FundoRingOAGB组术前平均GERD-HRQL胃灼热评分从20.6±2.24(19.96,21.23)提高到0.44±0.73(0.23,0,64);NissenOAGB组从21.34±2.43(20.64,22.03)提高到1.14±1.4(0.74,1.53);GB组20.5±2.17(1.1.25)。FundoRingOAGB组的GERD-HRQL总分从手术前25.2±2.7(24.4,25.9)到手术后4.34±1.3(3.96,4.7);NissenOAGB组的手术前24.8±2.93(24,25.67)到5.42±1.7(4.9,5.9);从21.46±2.7(20.7,22.2)到OA6.6)。FundoRingOAGB的平均VISICK评分从3.64±0.94(3.7,3.9)提高到1.48±1.26(1.12,1.84),NissenOAGB组从3.42±0.97(3.1,3,7)到2.5±1.46(2.06,2.9),OAGB组从3.38±0.88(3.1,3,69)到2.96±1.19(2.62,3.2)。结论:FundoRingOAGB的抗反流和减肥效果优于使用NissenOAGB方法,并且明显优于不使用胃底折叠术的OAGB。
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.