Haijanen J, Sippola S, Grönroos J, Rautio T, Nordström P, Rantanen T, Aarnio M, Ilves I, Hurme S, Marttila H, Virtanen J, Mattila A, Paajanen H, Salminen P
Division of Digestive Surgery and Urology, Turku University Hospital, Kiinanmyllynkatu 4-8, 20520, Turku, Finland.
Department of Surgery, University of Turku, Turku, Finland.
BMC Surg. 2018 Dec 17;18(1):117. doi: 10.1186/s12893-018-0451-y.
Based on epidemiological and clinical data acute appendicitis can present either as uncomplicated (70-80%) or complicated (20-30%) disease. Recent studies have shown that antibiotic therapy is both safe and cost-effective for a CT-scan confirmed uncomplicated acute appendicitis. However, based on the study protocols to ensure patient safety, these randomised studies used mainly broad-spectrum intravenous antibiotics requiring additional hospital resources and prolonged hospital stay. As we now know that antibiotic therapy for uncomplicated acute appendicitis is feasible and safe, further studies evaluating optimisation of the antibiotic treatment regarding both antibiotic spectrum and shorter hospital stay are needed to evaluate antibiotics as the first-line treatment for uncomplicated acute appendicitis.
APPAC II trial is a multicentre, open-label, non-inferiority randomised controlled trial comparing per oral (p.o.) antibiotic monotherapy with intravenous (i.v.) antibiotic therapy followed by p.o. antibiotics in the treatment of CT-scan confirmed uncomplicated acute appendicitis. Adult patients with CT-scan diagnosed uncomplicated acute appendicitis will be enrolled in nine Finnish hospitals. The intended sample size is 552 patients. Primary endpoint is the success of the randomised treatment, defined as resolution of acute appendicitis resulting in discharge from the hospital without the need for surgical intervention and no recurrent appendicitis during one-year follow-up. Secondary endpoints include post-intervention complications, late recurrence of acute appendicitis after one year, duration of hospital stay, pain, quality of life, sick leave and treatment costs. Primary endpoint will be evaluated in two stages: point estimates with 95% confidence interval (CI) will be calculated for both groups and proportion difference between groups with 95% CI will be calculated and evaluated based on 6 percentage point non-inferiority margin.
To our knowledge, APPAC II trial is the first randomised controlled trial comparing per oral antibiotic monotherapy with intravenous antibiotic therapy continued by per oral antibiotics in the treatment of uncomplicated acute appendicitis. The APPAC II trial aims to add clinical evidence on the debated role of antibiotics as the first-line treatment for a CT-confirmed uncomplicated acute appendicitis as well as to optimise the non-operative treatment for uncomplicated acute appendicitis.
Clinicaltrials.gov , NCT03236961, retrospectively registered on the 2nd of August 2017.
基于流行病学和临床数据，急性阑尾炎可表现为单纯性（70 - 80%）或复杂性（20 - 30%）疾病。近期研究表明，对于CT扫描确诊的单纯性急性阑尾炎，抗生素治疗既安全又具有成本效益。然而，根据确保患者安全的研究方案，这些随机研究主要使用广谱静脉抗生素，这需要额外的医院资源并延长住院时间。由于我们现在知道单纯性急性阑尾炎的抗生素治疗是可行且安全的，因此需要进一步研究以评估在抗生素谱和缩短住院时间方面优化抗生素治疗，从而将抗生素作为单纯性急性阑尾炎的一线治疗方法进行评估。
APPAC II试验是一项多中心、开放标签、非劣效性随机对照试验，比较口服抗生素单药治疗与静脉抗生素治疗后序贯口服抗生素治疗CT扫描确诊的单纯性急性阑尾炎的疗效。芬兰的九家医院将招募CT扫描诊断为单纯性急性阑尾炎的成年患者。预期样本量为552例患者。主要终点是随机治疗的成功，定义为急性阑尾炎消退，患者出院且无需手术干预，并且在一年随访期间无复发性阑尾炎。次要终点包括干预后并发症、一年后急性阑尾炎的晚期复发、住院时间、疼痛、生活质量、病假和治疗费用。主要终点将分两个阶段进行评估：计算两组的点估计值及其95%置信区间（CI），并计算两组之间比例差异及其95%CI，并基于6个百分点的非劣效性界值进行评估。
据我们所知，APPAC II试验是第一项比较口服抗生素单药治疗与静脉抗生素治疗后序贯口服抗生素治疗单纯性急性阑尾炎的随机对照试验。APPAC II试验旨在为抗生素作为CT确诊的单纯性急性阑尾炎一线治疗方法这一备受争议的作用增加临床证据，并优化单纯性急性阑尾炎的非手术治疗。
Clinicaltrials.gov，NCT03236961，于2017年8月2日进行回顾性注册。
