Department of Digestive and Bariatric Surgery, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France; CarMeN Laboratory, Université Claude Bernard Lyon 1, INSERM 1060, Lyon, France.
Hôpital Privé de la Loire, Saint-Étienne, France.
Lancet. 2019 Mar 30;393(10178):1299-1309. doi: 10.1016/S0140-6736(19)30475-1. Epub 2019 Mar 6.
One anastomosis gastric bypass (OAGB) is increasingly used in the treatment of morbid obesity. However, the efficacy and safety outcomes of this procedure remain debated. We report the results of a randomised trial (YOMEGA) comparing the outcomes of OAGB versus standard Roux-en-Y gastric bypass (RYGB).
This prospective, multicentre, randomised non-inferiority trial, was held in nine obesity centres in France. Patients were eligible for inclusion if their body-mass index (BMI) was 40 kg/m or higher, or 35 kg/m or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, or arthritis), and were aged 18-65 years. Key exclusion criteria were a history of oesophagitis, Barrett's oesophagus, severe gastro-oesophageal reflux disease resistant to proton-pump inhibitors, and previous bariatric surgery. Participants were randomly assigned (1:1) to OAGB or RYGB, stratified by centre with blocks of variable size; the study was open-label, with no masking required. RYGB consisted of a 150 cm alimentary limb and a 50 cm biliary limb and OAGB of a single gastrojejunal anastomosis with a 200 cm biliopancreatic limb. The primary endpoint was percentage excess BMI loss at 2 years. The primary endpoint was assessed in the per-protocol population and safety was assessed in all randomised participants. This study is registered with ClinicalTrials.gov, number NCT02139813, and is now completed.
From May 13, 2014, to March 2, 2016, of 261 patients screened for eligibility, 253 (97%) were randomly assigned to OAGB (n=129) or RYGB (n=124). Five patients did not undergo their assigned surgery, and after undergoing their surgery 14 were excluded from the per-protocol analysis (seven due to pregnancy, two deaths, one withdrawal, and four revisions from OAGB to RYGB) In the per-protocol population (n=117 OAGB, n=117 RYGB), mean age was 43·5 years (SD 10·8), mean BMI was 43·9 kg/m (SD 5·6), 176 (75%) of 234 participants were female, and 58 (27%) of 211 with available data had type 2 diabetes. After 2 years, mean percentage excess BMI loss was -87·9% (SD 23·6) in the OAGB group and -85·8% (SD 23·1) in the RYGB group, confirming non-inferiority of OAGB (mean difference -3·3%, 95% CI -9·1 to 2·6). 66 serious adverse events associated with surgery were reported (24 in the RYGB group vs 42 in the OAGB group; p=0·042), of which nine (21·4%) in the OAGB group were nutritional complications versus none in the RYGB group (p=0·0034).
OAGB is not inferior to RYGB regarding weight loss and metabolic improvement at 2 years. Higher incidences of diarrhoea, steatorrhoea, and nutritional adverse events were observed with a 200 cm biliopancreatic limb OAGB, suggesting a malabsorptive effect.
French Ministry of Health.
单吻合口胃旁路术（OAGB）在肥胖症的治疗中越来越多地被应用。然而，该手术的疗效和安全性结果仍存在争议。我们报告了一项随机试验（YOMEGA）的结果，该试验比较了 OAGB 与标准 Roux-en-Y 胃旁路术（RYGB）的结果。
这是一项前瞻性、多中心、随机非劣效性试验，在法国的九个肥胖中心进行。如果患者的身体质量指数（BMI）为 40kg/m2 或更高，或 35kg/m2 或更高且伴有至少一种合并症（2 型糖尿病、高血压、阻塞性睡眠呼吸暂停、血脂异常或关节炎），并且年龄在 18-65 岁之间，则符合纳入条件。主要排除标准为食管炎、巴雷特食管、质子泵抑制剂抵抗的严重胃食管反流病以及先前的减肥手术史。参与者按照 1:1 的比例随机分配（OAGB 或 RYGB），按中心分层，采用大小可变的块；该研究是开放标签的，不需要进行盲法。RYGB 包括 150cm 的食物通道和 50cm 的胆管通道，OAGB 包括 200cm 的胃空肠吻合口和 150cm 的胆管通道。主要终点是术后 2 年的超重 BMI 损失百分比。主要终点在符合方案人群中进行评估，安全性在所有随机参与者中进行评估。该研究在 ClinicalTrials.gov 上注册，编号为 NCT02139813，现已完成。
从 2014 年 5 月 13 日至 2016 年 3 月 2 日，在 261 名符合筛选条件的患者中，有 253 名（97%）被随机分配到 OAGB（n=129）或 RYGB（n=124）组。有 5 名患者未接受其指定的手术，14 名患者在术后被排除在符合方案的分析之外（7 名因怀孕、2 名死亡、1 名退出和 4 名从 OAGB 转为 RYGB）。在符合方案的人群（n=117 OAGB，n=117 RYGB）中，平均年龄为 43.5 岁（标准差 10.8），平均 BMI 为 43.9kg/m2（标准差 5.6），234 名参与者中有 176 名（75%）为女性，211 名有可用数据的参与者中有 58 名（27%）患有 2 型糖尿病。术后 2 年，OAGB 组的超重 BMI 损失百分比为-87.9%（标准差 23.6），RYGB 组为-85.8%（标准差 23.1），证实 OAGB 的非劣效性（平均差值-3.3%，95%置信区间-9.1%至 2.6%）。共报告了 66 例与手术相关的严重不良事件（RYGB 组 24 例，OAGB 组 42 例；p=0.042），其中 OAGB 组 9 例（21.4%）为营养并发症，RYGB 组无此类并发症（p=0.0034）。
在术后 2 年时，OAGB 在减重和代谢改善方面与 RYGB 相比并不劣效。OAGB 组更高的腹泻、脂肪泻和营养不良不良事件发生率表明存在吸收不良作用。
法国卫生部。
