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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
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:
基于小肠总长度与标准肢体长度在一次胃绕道吻合术中调整胆胰肢体长度的效果:TAILOR 随机临床优越性试验的 1 年结果。
背景 在回顾性研究中,提出在一次吻合胃绕道术中调整胆胰肢体长度是有益的,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,基于小肠总长度 (TSBL) 调整胆胰肢体长度是否会在一次胃绕道手术吻合后产生更好的结果。方法 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、计划进行一期胃绕道手术并愿意随机分组的合格患者在手术期间接受 TSBL 测量。当 TSBL 测量可行时,患者被随机分配至标准 150 cm 胆胰肢长度或根据 TSBL 量身定制的胆胰肢:TSBL 小于 500 cm,胆胰肢 150 cm; TSBL 500-700 cm,胆胰肢180 cm; TSBL 大于 700 cm,胆胰肢 210 cm。主要结果是 5 年时总体重减轻百分比。结果 2020年9月至2022年8月期间,212名患者被随机分为标准胆胰肢组(105名患者)或定制胆胰肢组(107名患者)。平均(标准差)TSBL 为 657(128)cm(范围 295-1020 cm)。在定制组中,150、180和210厘米的胆胰肢体长度分别适用于8.4%、53.3%和38.3%的患者。标准组的平均(标准差)1 年总体重减轻百分比为 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没有显着差异。 结论基于TSBL定制胆胰肢体长度是安全可行的。术后一年,就总体重减轻百分比而言,它并不优于标准胆胰肢体长度 150 厘米。注册号荷兰试用注册号,NL7945。
更新日期:2024-08-30
中文翻译:
基于小肠总长度与标准肢体长度在一次胃绕道吻合术中调整胆胰肢体长度的效果:TAILOR 随机临床优越性试验的 1 年结果。
背景 在回顾性研究中,提出在一次吻合胃绕道术中调整胆胰肢体长度是有益的,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,基于小肠总长度 (TSBL) 调整胆胰肢体长度是否会在一次胃绕道手术吻合后产生更好的结果。方法 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、计划进行一期胃绕道手术并愿意随机分组的合格患者在手术期间接受 TSBL 测量。当 TSBL 测量可行时,患者被随机分配至标准 150 cm 胆胰肢长度或根据 TSBL 量身定制的胆胰肢:TSBL 小于 500 cm,胆胰肢 150 cm; TSBL 500-700 cm,胆胰肢180 cm; TSBL 大于 700 cm,胆胰肢 210 cm。主要结果是 5 年时总体重减轻百分比。结果 2020年9月至2022年8月期间,212名患者被随机分为标准胆胰肢组(105名患者)或定制胆胰肢组(107名患者)。平均(标准差)TSBL 为 657(128)cm(范围 295-1020 cm)。在定制组中,150、180和210厘米的胆胰肢体长度分别适用于8.4%、53.3%和38.3%的患者。标准组的平均(标准差)1 年总体重减轻百分比为 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没有显着差异。 结论基于TSBL定制胆胰肢体长度是安全可行的。术后一年,就总体重减轻百分比而言,它并不优于标准胆胰肢体长度 150 厘米。注册号荷兰试用注册号,NL7945。