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腹腔镜 Roux-Y 胃旁路术与腹腔镜单吻合口胃旁路术治疗肥胖症的比较:一项前瞻性随机对照临床试验的临床和代谢结果。

Laparoscopic Roux-Y-gastric bypass versus laparoscopic one-anastomosis gastric bypass for obesity: clinical & metabolic results of a prospective randomized controlled trial.

机构信息

Department of Surgery, Obesity & Bariatric Surgery Centre, Limmattal Hospital, 8952, Zurich-Schlieren, Switzerland.

University of Basel, Petersplatz 1, 4001, Basel, Switzerland.

出版信息

Surg Endosc. 2024 Jul;38(7):3875-3886. doi: 10.1007/s00464-024-10907-7. Epub 2024 Jun 3.

DOI:10.1007/s00464-024-10907-7
PMID:38831218
Abstract

BACKGROUND

One anastomosis gastric bypass (OAGB) has been proposed as an effective alternative to the current standard procedure in Switzerland, Roux-en-Y gastric bypass (RYGB). Prospective data comparing both procedures are scarce. Therefore, we performed a non-inferiority randomized controlled trial assessing the effectiveness and safety of these 2 operative techniques.

METHOD

Eighty patients were randomized 1:1. OAGB consisted of a very long gastric pouch with a 200 cm biliopancreatic limb, RYGB of a 150 cm ante-colic alimentary and a 60 cm biliopancreatic limb, respectively. Primary endpoint was the percent excess weight loss (%EWL) at 12 months after surgery.

RESULTS

Mean %EWL at 12 months was 87.9% (SD24.4) in the RYGB group and 104.1% (SD24.6) in the OAGB group (p = 0.006). There was no mortality. The rate of marginal ulcers was higher in patients with OAGB compared to those with RYGB (p = 0.011), while the total number of late complications did not statistically differ between the two groups. Except for the remission of GERD, which was higher in the RYGB group compared to OAGB, there was no difference between the groups regarding the remission of comorbidities. OAGB showed improved glucose control compared to the RYGB after 1 year (p = 0.001). Furthermore, glucagon-like peptide-1 increase was significantly higher in OAGB at 6 weeks (p = 0.041) and 1 year after surgery (p = 0.029). Quality of life improved after both surgeries, without differences between the groups.

CONCLUSIONS

%EWL 1 year after surgery was higher in OAGB than in RYGB. A better glycemic control with a higher increase in GLP-1 was observed after OAGB compared to RYGB.

TRIAL REGISTRATION

This trial is registered on ClinicalTrials.gov under the identifier NCT02601092.

摘要

背景

一种吻合口胃旁路术(OAGB)已被提议作为瑞士当前标准手术——Roux-en-Y 胃旁路术(RYGB)的有效替代方案。比较这两种手术的前瞻性数据很少。因此,我们进行了一项非劣效性随机对照试验,评估这两种手术技术的有效性和安全性。

方法

80 名患者以 1:1 的比例随机分组。OAGB 由一个非常长的胃囊和一个 200cm 的胆胰支组成,RYGB 由一个 150cm 的结肠前肠和一个 60cm 的胆胰支组成。主要终点是术后 12 个月时的超重体重减轻百分比(%EWL)。

结果

RYGB 组 12 个月时的平均%EWL 为 87.9%(24.4%SD),OAGB 组为 104.1%(24.6%SD)(p=0.006)。无死亡病例。OAGB 组的边缘溃疡发生率高于 RYGB 组(p=0.011),而两组晚期并发症总数无统计学差异。除 RYGB 组 GERD 缓解率高于 OAGB 组外,两组在并发症缓解方面无差异。OAGB 在术后 1 年时的血糖控制优于 RYGB(p=0.001)。此外,术后 6 周(p=0.041)和 1 年(p=0.029)时,OAGB 的胰高血糖素样肽-1(GLP-1)增加显著高于 RYGB。两种手术均改善了生活质量,两组间无差异。

结论

术后 1 年时,OAGB 的 EWL 百分比高于 RYGB。与 RYGB 相比,OAGB 术后血糖控制更好,GLP-1 增加更高。

试验注册

该试验在 ClinicalTrials.gov 注册,标识符为 NCT02601092。

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