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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.
British Journal of Surgery ( IF 8.6 ) Pub Date : 2024-08-30 , DOI: 10.1093/bjs/znae219
Nienke Slagter 1, 2, 3, 4 , Lindsy van der Laan 1, 2, 3, 4 , Loek J M de Heide 1, 2 , Ewoud H Jutte 1, 2 , Mirjam A Kaijser 1, 2 , Stefan L Damen 1, 2 , André P van Beek 3, 4 , Marloes Emous 1, 2
Affiliation  

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.

中文翻译:


在一次吻合胃旁路术中,根据总小肠长度与标准肢体长度定制胆胰肢体长度的影响:TAILOR 随机临床优效性试验的 1 年结果。



背景 在回顾性研究中,调整一次吻合胃旁路手术中胆胰肢体的长度被认为是有益的,但缺乏随机试验。这项双盲、单中心随机对照试验的目的是确定与固定的 150 cm 胆胰肢体长度相比,根据总小肠长度 (TSBL) 定制胆胰肢体长度是否在一次吻合胃旁路手术后产生更好的结局。方法 符合条件的患者,符合国际肥胖和代谢紊乱外科联合会 (IFSO) 代谢减肥手术标准,计划进行初次一期吻合胃旁路手术,并愿意随机分组,在手术期间接受了 TSBL 测量。当 TSBL 测量可行时,将患者随机分配到标准 150 cm 胆胰肢体长度或基于 TSBL 量身定制的胆胰肢体:TSBL 小于 500 cm,胆胰肢体 150 cm;TSBL 500-700 cm,胆胰肢体 180 cm;TSBL 大于 700 cm,胆胰肢 210 cm。主要结局是 5 年时总重减轻百分比。结果 2020 年 9 月至 2022 年 8 月期间,212 例患者被随机分为标准胆胰肢组 (105 例患者) 或定制胆胰肢组 (107 例患者)。平均 (s.d.) TSBL 为 657(128) cm (范围 295-1020 cm)。在定制组中,150 、 180 和 210 cm 胆胰肢体长度分别应用于 8.4% 、 53.3% 和 38.3% 的患者。标准组 1 年总重减轻百分比平均值为 32.8(6.9)%,定制组为 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 定制胆胰肢体长度是安全可行的。手术后 1 年,就总重量减轻百分比而言,它并不优于 150 cm 的标准胆胰肢体长度。注册号 荷兰审判登记册,NL7945。
更新日期:2024-08-30
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