Optimising the treatment for uncomplicated acute appendicitis (OPTIMA trial): a protocol for a multicentre, randomised, double-blinded placebo-controlled study.
Optimising the treatment for uncomplicated acute appendicitis (OPTIMA trial): a protocol for a multicentre, randomised, double-blinded placebo-controlled study.
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DOI：
10.1136/bmjopen-2021-057793
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发表时间：
2022-05-02
期刊：
影响因子：
2.9
通讯作者：
Ren, Jianan
中科院分区：
文献类型：
--
作者：
Wu, Jie;Jiang, Haiyang;Li, Shikuan;Wu, Xiuwen;Wang, Peige;Sawyer, Robert;Ren, Jianan
新出现的证据表明，抗生素优先策略是治疗无并发症的急性阑尾炎(AA)的可行选择。尽管最近抗生素作为治疗无并发症再生障碍性贫血的主要策略受到越来越多的关注，但对于最佳的抗生素方案还没有达成共识。特别是，不同抗生素方案的长期结果，如复发率，仍然缺乏证据。鉴于阑尾的菌群主要是厌氧菌，我们推测，与不含抗厌氧抗生素的方案相比，抗厌氧菌方案可以降低复发率。OPTIMA(优化无并发症急性阑尾炎的治疗)试验是一项多中心、双盲、安慰剂对照的优势随机研究，旨在评估抗厌氧抗生素在解决无并发症再生障碍性贫血中的作用。无并发症AA(无坏疽、穿孔性阑尾炎、阑尾脓肿或阑尾粪便)患者(18-65 岁)符合纳入条件。这项研究的主要终点是治疗的成功率，定义为AA在一年内不需要手术干预而出院和复发症状的解决。次要终点包括死亡率、干预后并发症、治疗后长达一年的复发症状、住院时间、病假、治疗费用、疼痛症状评分和生活质量。数据报告为病例数(%)、中位数(范围)和相对风险，这些数据将根据需要使用曼恩-惠特尼U检验或χ2检验进行分析。P-Value<；0.05 将被认为意义重大。该方案已于2018年11月13日通过金陵医院伦理委员会(2018NZKY-027-01)。试验结果将发表在同行评议的期刊上。ChiCTR1800018896。
Emerging evidence has shown that an antibiotic first strategy is a viable treatment option for uncomplicated acute appendicitis (AA). Although there has recently been an interest and increase in the use of antibiotics as the primary strategy for treating uncomplicated AA, there is no consensus regarding the optimum antibiotic regimen. In particular, the long-term outcomes of different antibiotic regimens, such as the recurrence rate, still lack evidence. Given that the flora of the appendix is mainly anaerobic bacteria, we hypothesised that antianaerobe regimens could decrease the recurrence rate compared with those that did not include antianaerobic antibiotics. The OPTIMA(Optimising the treatment for uncomplicated acute appendicitis) trial is a multicentre, double-blinded placebo-controlled superiority randomised study aimed to evaluate the role of antianaerobic antibiotics in the resolution of uncomplicated AA. Patients (18–65 years) with uncomplicated AA (without gangrenous, perforated appendicitis, appendiceal abscess, or appendiceal fecaliths) are eligible for inclusion. The primary endpoint of this study is the success rate of the treatment, defined as the resolution of AA resulting in discharge from the hospital without surgical intervention and recurrent symptoms within one year. Secondary endpoints include mortality, postintervention complications, recurrent symptoms up to one year after treatment, hospital stay, sick leave, treatment cost, pain symptom scores and quality of life. Data are reported as the number of cases (%), median (range) and relative risk, which will be analysed using the Mann-Whitney U test or χ2 test, as appropriate. P-value<0.05 will be considered significant. The protocol has been approved by the Ethics Committee of Jinling Hospital on 13 November 2018 (2018NZKY-027-01). The trial findings will be published in peer-reviewed journals. ChiCTR1800018896.
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影响因子：
2.6
作者：
Andersson M;Kolodziej B;Andersson RE
通讯作者：
Andersson RE
影响因子：
8
作者：
Georgiou, Roxani;Eaton, Simon;Hall, Nigel J.
通讯作者：
Hall, Nigel J.
COVID-19 大流行对德国阑尾炎治疗的影响——基于人群的分析。
DOI：
10.1007/s00423-021-02081-4
发表时间：
2021-03
期刊：
Langenbeck's archives of surgery
影响因子：
--
作者：
Köhler F;Acar L;van den Berg A;Flemming S;Kastner C;Müller S;Diers J;Germer CT;Lock JF;L'hoest H;Marschall U;Wiegering A
通讯作者：
Wiegering A
影响因子：
26.1
作者：
Huang, Libin;Yin, Yuan;Zhou, Zongguang
通讯作者：
Zhou, Zongguang
影响因子：
120.7
作者：
Salminen, Paulina;Tuominen, Risto;Gronroos, Juha M.
通讯作者：
Gronroos, Juha M.