A randomised placebo-controlled double-blind multicentre trial comparing antibiotic therapy with placebo in the treatment of uncomplicated acute appendicitis: APPAC III trial study protocol.
A randomised placebo-controlled double-blind multicentre trial comparing antibiotic therapy with placebo in the treatment of uncomplicated acute appendicitis: APPAC III trial study protocol.
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DOI：
10.1136/bmjopen-2018-023623
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发表时间：
2018-11-03
期刊：
影响因子：
2.9
通讯作者：
Salminen P
中科院分区：
文献类型：
--
作者：
Sippola S;Grönroos J;Sallinen V;Rautio T;Nordström P;Rantanen T;Hurme S;Leppäniemi A;Meriläinen S;Laukkarinen J;Savolainen H;Virtanen J;Salminen P
近年来的研究表明，抗生素治疗CT证实的无并发症急性阑尾炎是安全可行的。急性阑尾炎的自然消退在一百多年前就已经被观察到了。在CT证实的无并发症的急性憩室炎（左侧阑尾炎）中，研究显示与对症治疗相比，抗生素没有任何益处，但这种从抗生素到对症治疗的转变尚未在临床实践中广泛实施。最近，在韩国的一项开放标签研究中证实了无并发症急性阑尾炎的对症治疗。然而，双盲安慰剂对照研究，以说明抗生素的作用，并自发解决简单的急性阑尾炎仍然缺乏。APPAC III（急性阑尾炎III）试验是一项多中心、双盲、安慰剂对照、优效性随机化研究，比较抗生素治疗与安慰剂治疗CT扫描证实的无并发症急性阑尾炎，旨在评价抗生素在无并发症急性阑尾炎消退中的作用。经CT扫描证实的无并发症急性阑尾炎（无阑尾结石、脓肿、穿孔和肿瘤）成人患者（18 - 60岁）将在五所芬兰大学医院入组。主要终点是随机化治疗的成功，定义为急性阑尾炎消退，导致在开始随机化治疗后10天内出院，无需手术干预（治疗疗效）。次要终点包括干预后并发症、治疗后1年内复发症状、1年后急性阑尾炎晚期复发、住院时间、病假、治疗费用和生活质量。成功率降低15个百分点被认为是具有临床意义的差异。将使用Fisher单侧检验分析抗生素治疗与安慰剂相比的优效性，并计算比例差异的CI。本方案已获得图尔库大学医院伦理委员会和芬兰药品管理局（FIMEA）的批准。研究结果将在同行评审的学术期刊上发布。 NCT 03234296;预结果。
Recent studies show that antibiotic therapy is safe and feasible for CT-confirmed uncomplicated acute appendicitis. Spontaneous resolution of acute appendicitis has already been observed over a hundred years ago. In CT-confirmed uncomplicated acute diverticulitis (left-sided appendicitis), studies have shown no benefit from antibiotics compared with symptomatic treatment, but this shift from antibiotics to symptomatic treatment has not yet been widely implemented in clinical practice. Recently, symptomatic treatment of uncomplicated acute appendicitis has been demonstrated in a Korean open-label study. However, a double-blinded placebo-controlled study to illustrate the role of antibiotics and spontaneous resolution of uncomplicated acute appendicitis is still lacking. The APPAC III (APPendicitis ACuta III) trial is a multicentre, double-blind, placebo-controlled, superiority randomised study comparing antibiotic therapy with placebo in the treatment CT scan-confirmed uncomplicated acute appendicitis aiming to evaluate the role of antibiotics in the resolution of uncomplicated acute appendicitis. Adult patients (18–60 years) with CT scan-confirmed uncomplicated acute appendicitis (the absence of appendicolith, abscess, perforation and tumour) will be enrolled in five Finnish university hospitals. Primary endpoint is success of the randomised treatment, defined as resolution of acute appendicitis resulting in discharge from the hospital without surgical intervention within 10 days after initiating randomised treatment (treatment efficacy). Secondary endpoints include postintervention complications, recurrent symptoms after treatment up to 1 year, late recurrence of acute appendicitis after 1 year, duration of hospital stay, sick leave, treatment costs and quality of life. A decrease of 15 percentage points in success rate is considered clinically important difference. The superiority of antibiotic treatment compared with placebo will be analysed using Fisher’s one-sided test and CI will be calculated for proportion difference. This protocol has been approved by the Ethics Committee of Turku University Hospital and the Finnish Medicines Agency (FIMEA). The findings will be disseminated in peer-reviewed academic journals. NCT03234296; Pre-results.
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