The first management using intubation of a nasogastric tube with Gastrografin enterography or long tube for non-strangulated acute small bowel obstruction: a multicenter, randomized controlled trial
The first management using intubation of a nasogastric tube with Gastrografin enterography or long tube for non-strangulated acute small bowel obstruction: a multicenter, randomized controlled trial
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DOI：
10.1007/s00535-020-01708-5
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发表时间：
2020-07-15
影响因子：
6.3
通讯作者：
Kataoka, Hiromi
中科院分区：
文献类型：
--
作者：
Katano, Takahito;Shimura, Takaya;Kataoka, Hiromi
背景胃肠减压术通常应用于非绞窄性急性小肠梗阻（NSASBO）。尽管在先前的研究中，长管（LT）放置和通过鼻胃管（NGT-G）给予泛影葡胺显示出优于单独的NGT，但似乎没有研究比较LT和NGT-G。方法在这项多中心、随机对照试验中，NSASBO患者于2016年7月至2018年11月在11家日本机构随机分配接受LT或NGT-G治疗。主要终点是NGT-G与LT相比非手术率的非劣效性，非手术率的95%置信区间下限（-15%）被设定为NGT-G与LT相比劣效性的下限。结果在本试验中，共分析了223例患者（LT组，n = 111; NGT-G组，n = 112）。LT组的非手术率为87.4%，NGT-G组为91.1%，NGT-G组与LT组之间的差异为3.7%（95.3%CI - 5.55 - 12.91;非手术率P = 0.00002923）。另一方面，单纯NGT-G的非手术率（76.8%）（代表非交叉NGT-G，随后未进行LT）显著低于LT（P = 0.039）。NGT-G组的中位手术时间（1 min）明显短于LT组（25 min;P < 0.001），但两组之间的死亡率或住院时间无显著差异。结论NGT-G是治疗NSASBO的有效替代方案。由NGT-G和LT组成的顺序策略可能为NSASBO提供新的标准。
Background Gastrointestinal decompression is generally applied to a non-strangulated acute small bowel obstruction (NSASBO). Although long tube (LT) placement and administration of Gastrografin through a nasogastric tube (NGT-G) have shown advantages over NGT alone in previous studies, no studies appear to have compared LT and NGT-G. Methods In this multicenter, randomized controlled trial, patients with NSASBO were randomly assigned to receive LT or NGT-G between July 2016 and November 2018 at 11 Japanese institutions. The primary endpoint was non-inferiority of NGT-G compared to LT for non-surgery rate, and the lower limit of the 95% confidence interval for the non-surgery rate (-15%) was set as the lower margin for inferiority of NGT-G compared to LT. Results In total, 223 patients (LT group,n = 111; NGT-G group,n = 112) were analyzed in the present trial. The non-surgery rate was 87.4% in the LT group and 91.1% in the NGT-G group, with a 3.7% difference between NGT-G and LT (95.3%CI - 5.55 to 12.91; non-inferiorityP = 0.00002923). On the other hand, the non-surgery rate with pure NGT-G alone (76.8%) that represents non-cross-over NGT-G without subsequent LT was significantly lower than that with LT (P = 0.039). Median procedure time was significantly shorter with NGT-G (1 min) than with LT (25 min;P < 0.001), whereas no significant differences in mortality or hospital stay were noted between groups. Conclusion NGT-G is an effective alternative to LT as a first-line treatment for NSASBO. A sequential strategy comprising NGT-G followed by LT might offer a new standard for NSASBO.