Randomized clinical trial of 24 versus 72 h antimicrobial prophylaxis in patients undergoing open total gastrectomy for gastric cancer.
Randomized clinical trial of 24 versus 72 h antimicrobial prophylaxis in patients undergoing open total gastrectomy for gastric cancer.
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对因胃癌接受开腹全胃切除术的患者进行 24 小时与 72 小时抗菌药物预防的随机临床试验。
DOI：
10.1002/bjs.10439
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发表时间：
2017
期刊：
影响因子：
--
通讯作者：
Sumiyama Y
中科院分区：
文献类型：
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作者：
Takagane A;Mohri Y;Konishi T;Fukushima R;Noie T;Sueyoshi S;Omura K;Ono S;Kusunoki M;Mochizuki H;Sumiyama Y
背景开放性全胃切除术具有较高的手术部位感染（SSI）风险。本研究评价了非劣效性的抗菌预防24小时相比，开放式全胃切除术后72小时。MethodsAn开放标签，随机，非劣效性研究在日本的57个机构进行。合格的患者是那些接受开放性全胃切除术的胃癌。患者被随机分配到术后24或72 h继续使用β-内酰胺酶抑制剂。主要终点是SSI的发生率，非劣效性基于9个百分点的界值和90%的置信区间。次要终点是远程infection.ResultsA的发病率共464例（24小时预防，228; 72小时预防，236）进行了分析。24小时预防组中有20名患者（8.8%）发生SSI，72小时预防组中有26名患者（11.0%）发生SSI（绝对差-2.2（90% c.i.− 6.8至2.4）%;非劣效性P<0.001）。然而，远程感染的发病率显着较高，在24小时的预防group.ConclusionAntimicrobial预防24小时后全胃切除术不低于72小时预防SSI。缩短抗生素预防可能会增加远程感染的发生率。注册号：UMIN 000001062（http：www.umin.ac.jp）。
BackgroundOpen total gastrectomy carries a high risk of surgical-site infection (SSI). This study evaluated the non-inferiority of antimicrobial prophylaxis for 24 compared with 72 h after open total gastrectomy.MethodsAn open-label, randomized, non-inferiority study was conducted at 57 institutions in Japan. Eligible patients were those who underwent open total gastrectomy for gastric cancer. Patients were assigned randomly to continued use of β-lactamase inhibitor for either 24 or 72 h after surgery. The primary endpoint was the incidence of SSI, with non-inferiority based on a margin of 9 percentage points and a 90 per cent c.i. The secondary endpoint was the incidence of remote infection.ResultsA total of 464 patients (24 h prophylaxis, 228; 72 h prophylaxis, 236) were analysed. SSI occurred in 20 patients (8·8 per cent) in the 24-h prophylaxis group and 26 (11·0 per cent) in the 72-h group (absolute difference −2·2 (90 per cent c.i. −6·8 to 2·4) per cent;P< 0·001 for non-inferiority). However, the incidence of remote infection was significantly higher in the 24-h prophylaxis group.ConclusionAntimicrobial prophylaxis for 24 h after total gastrectomy is not inferior to 72 h prophylaxis for prevention of SSI. Shortened antimicrobial prophylaxis might increase the incidence of remote infection. Registration number: UMIN000001062 (http://www.umin.ac.jp).