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基于全小肠长度与标准胆胰支长度对吻合口胃旁路术行个体化胆胰支长度的效果:TAILOR 随机临床优势试验的 1 年结果。

Effect of tailoring biliopancreatic limb length based on total small bowel length versus standard limb length in one anastomosis gastric bypass: 1-year outcomes of the TAILOR randomized clinical superiority trial.

机构信息

Center for Obesity Northern Netherlands, Department of Bariatric and Metabolic Surgery, Medical Center Leeuwarden, Leeuwarden, The Netherlands.

Department of Surgery, Medical Center Leeuwarden, Leeuwarden, The Netherlands.

出版信息

Br J Surg. 2024 Aug 30;111(9). doi: 10.1093/bjs/znae219.

Abstract

BACKGROUND

Tailoring the biliopancreatic limb length in one anastomosis gastric bypass is proposed as beneficial in retrospective studies, yet randomized trials are lacking. The aim of this double-blind, single-centre RCT was to ascertain whether tailoring biliopancreatic limb length based on total small bowel length (TSBL) results in superior outcomes after one anastomosis gastric bypass compared with a fixed 150 cm biliopancreatic limb length.

METHODS

Eligible patients, meeting International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) criteria for metabolic bariatric surgery, scheduled for primary one anastomosis gastric bypass surgery, and willing to be randomized, underwent TSBL measurement during surgery. When TSBL measurement was feasible, patients were randomly assigned to a standard 150 cm biliopancreatic limb length or a tailored biliopancreatic limb based on TSBL: TSBL less than 500 cm, biliopancreatic limb 150 cm; TSBL 500-700 cm, biliopancreatic limb 180 cm; and TSBL greater than 700 cm, biliopancreatic limb 210 cm. The primary outcome was percentage total weight loss at 5 years.

RESULTS

Between September 2020 and August 2022, 212 patients were randomized into the standard biliopancreatic limb group (105 patients) or the tailored biliopancreatic limb group (107 patients). The mean(s.d.) TSBL was 657(128) cm (range 295-1020 cm). In the tailored group, 150, 180, and 210 cm biliopancreatic limb lengths were applied to 8.4%, 53.3%, and 38.3% of patients respectively. The mean(s.d.) 1-year percentage total weight loss was 32.8(6.9)% in the standard group and 33.1(6.2)% in the tailored group (P = 0.787). Nutritional deficiencies and short-term complications showed no significant differences.

CONCLUSION

Tailoring biliopancreatic limb length based on TSBL is safe and feasible. One year after surgery, it is not superior to a standard biliopancreatic limb length of 150 cm in terms of percentage total weight loss.

REGISTRATION NUMBER

Dutch Trial Register, NL7945.

摘要

背景

在一项吻合口胃旁路手术中,将胆胰支长度定制为一个吻合口被认为是有益的,尽管缺乏随机对照试验。本双盲、单中心 RCT 的目的是确定基于总小肠长度(TSBL)定制胆胰支长度是否优于固定 150cm 的胆胰支长度,从而在吻合口胃旁路手术后获得更好的结果。

方法

符合国际肥胖与代谢外科学会(IFSO)代谢减重手术标准、计划行初次吻合口胃旁路手术且愿意接受随机分组的合格患者,在手术期间进行 TSBL 测量。当可行 TSBL 测量时,患者被随机分配至标准 150cm 胆胰支长度或基于 TSBL 的定制胆胰支长度:TSBL<500cm,胆胰支 150cm;TSBL 500-700cm,胆胰支 180cm;TSBL>700cm,胆胰支 210cm。主要结局为 5 年时的总体重减轻百分比。

结果

2020 年 9 月至 2022 年 8 月,212 例患者被随机分为标准胆胰支组(105 例)或定制胆胰支组(107 例)。TSBL 的平均值(标准差)为 657(128)cm(范围 295-1020cm)。在定制组中,150cm、180cm 和 210cm 的胆胰支长度分别适用于 8.4%、53.3%和 38.3%的患者。标准组和定制组的 1 年总体重减轻百分比分别为 32.8(6.9)%和 33.1(6.2)%(P=0.787)。营养缺乏和短期并发症无显著差异。

结论

基于 TSBL 定制胆胰支长度是安全可行的。术后 1 年,在总体重减轻百分比方面,与 150cm 的标准胆胰支长度相比并不具有优势。

注册号

荷兰临床试验注册中心,NL7945。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d647/11363871/ed5a3de47a0d/znae219f1.jpg

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