Acute Cholecystitis Early Versus Delayed Cholecystectomy, A Multicenter Randomized Trial (ACDC Study, NCT00447304)
Acute Cholecystitis Early Versus Delayed Cholecystectomy, A Multicenter Randomized Trial (ACDC Study, NCT00447304)
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DOI：
10.1097/sla.0b013e3182a1599b
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发表时间：
2013-09-01
影响因子：
9
通讯作者：
Buechler, Markus W.
中科院分区：
文献类型：
--
作者：
Gutt, Carsten N.;Encke, Jens;Buechler, Markus W.
目的：急性胆囊炎是一种常见病，腹腔镜手术是标准的治疗方法。背景：急性胆囊炎手术的最佳时机仍存在争议：要么在入院后不久进行早期手术，要么在抗生素保守治疗后延迟择期手术。所述ACDC（“急性胆囊炎-早期腹腔镜手术与抗生素治疗和延迟选择性胆囊炎”）研究是一项随机，前瞻性，开放标签、平行组试验。将患者随机分为两组，一组在入院后24小时内立即接受手术（ILC组），另一组接受初始抗生素治疗，然后在第7天至第45天延迟腹腔镜胆囊切除术（DLC组）。对于感染，所有患者均接受利多卡因治疗至少48小时。主要终点是75天内发生预定义的相关发病率。次要终点如下：（1）使用评分系统的75天发病率;（2）转换率;（3）抗生素治疗的变化;（4）死亡率;（5）费用;（6）住院时间。结果：ILC组（304例患者）的发病率显著低于DLC组（314例患者）：11.8%对34.4%。两组之间的开放手术转换率和死亡率没有显著差异。ILC组的平均住院时间（5.4天vs 10.0天; P < 0.001）和总住院费用（（原文如此）2919 vs（原文如此）4262; P < 0.001）显着较低。结论：在这项大型随机试验中，入院24小时内的腹腔镜胆囊切除术在发病率和费用方面上级保守方法。因此，我们认为，立即腹腔镜胆囊切除术应成为治疗急性胆囊炎手术患者的选择。（NCT00447304）
Objective: Acute cholecystitis is a common disease, and laparoscopic surgery is the standard of care.Background: Optimal timing of surgery for acute cholecystitis remains controversial: either early surgery shortly after hospital admission or delayed elective surgery after a conservative treatment with antibiotics.Methods: The ACDC ("Acute Cholecystitis-early laparoscopic surgery versus antibiotic therapy and Delayed elective Cholecystectomy") study is a randomized, prospective, open-label, parallel group trial. Patients were randomly assigned to receive immediate surgery within 24 hours of hospital admission (group ILC) or initial antibiotic treatment, followed by delayed laparoscopic cholecystectomy at days 7 to 45 (group DLC). For infection, all patients were treated with moxifloxacin for at least 48 hours. Primary endpoint was occurrence of predefined relevant morbidity within 75 days. Secondary endpoints were as follows: (1) 75-day morbidity using a scoring system; (2) conversion rate; (3) change of antibiotic therapy; (4) mortality; (5) costs; and (6) length of hospital stay.Results: Morbidity rate was significantly lower in group ILC (304 patients) than in group DLC (314 patients): 11.8% versus 34.4%. Conversion rate to open surgery and mortality did not differ significantly between groups. Mean length of hospital stay (5.4 days vs 10.0 days; P < 0.001) and total hospital costs ((sic)2919 vs (sic)4262; P < 0.001) were significantly lower in group ILC.Conclusions: In this large, randomized trial, laparoscopic cholecystectomy within 24 hours of hospital admission was shown to be superior to the conservative approach concerning morbidity and costs. Therefore, we believe that immediate laparoscopic cholecystectomy should become therapy of choice for acute cholecystitis in operable patients. (NCT00447304)