Appendicectomy remains the standard treatment for appendicitis. No international consensus exists on the surgical urgency for acute uncomplicated appendicitis, and recommendations vary from surgery without delay to surgery within 24 h. Longer in-hospital delay has been thought to increase the risk of perforation and further morbidity. Therefore, we aimed to compare the rate of appendiceal perforation in patients undergoing appendicectomy scheduled to two different urgencies (<8 h <24 h). In this pragmatic, open-label, multicentre, non-inferiority, parallel, randomised controlled trial in two hospitals in Finland and one in Norway, patients (aged ≥18 years) with presumed uncomplicated acute appendicitis were randomly assigned (1:1) to an appendicectomy scheduled within 8 h or within 24 h to determine whether longer in-hospital delay (time between randomisation and surgical incision) is not inferior to shorter delay. Patients were excluded in cases of pregnancy, suspicion of perforated appendicitis (C-reactive protein level of ≥100 mg/L, fever >38·5°C, signs of complicated appendicitis on imaging studies, or clinical generalised peritonitis), or other reasons requiring prompt surgery. The recruiters were on-duty surgeons who decided to proceed with the appendicectomy. The randomisation sequence was generated using block randomisation with randomly varying block sizes and stratified by hospital districts; neither physicians nor patients were masked to group assignment. The primary outcome was perforated appendicitis diagnosed during surgery analysed in all patients who received an appendicectomy by intention to treat. The absolute difference in rates of perforated appendicitis was compared between the groups. Complications and other safety outcomes were analysed in all patients who received an appendicectomy. A margin of 5 percentage points was used to establish non-inferiority. This trial was registered at () and is closed to accrual. Between May 18, 2020, and Dec 31, 2022, 2095 patients were assessed for eligibility, of whom 1822 were randomly assigned to appendicectomy scheduled within 8 h (n=914) or 24 h (n=908). After randomisation, 19 (1%) of 1822 patients were excluded due to protocol violation. 1803 patients were included in the intention-to-treat analyses, 985 (55%) of whom were male and 818 (45%) female. Appendiceal perforation rate was similar between groups (77 [8%] of 907 patients assigned to the <8 h group and 81 [9%] of 896 patients assigned to the <24 h group; absolute risk difference 0·6% [95% CI –2·1 to 3·2], p=0·68; risk ratio 1·065, 95% CI 0·790 to 1·435). No significant difference was found between the complication rates within 30 days (66 [7%] of 907 patients in the <8 h group 56 [6%] of 896 patients in the <24 h group; difference –1·0% [–3·3 to 1·3]; p=0·39), and no deaths occurred during this follow-up period. In patients with presumed uncomplicated acute appendicitis, scheduling appendicectomy within 24 h does not increase the risk of appendiceal perforation compared with scheduling appendicectomy within 8 h. The results can be used to allocate operating room resources, for example postponing night-time appendicectomy to daytime. The Finnish Medical Foundation, Mary and Georg Ehrnrooth's Foundation, Biomedicum Helsinki Foundation, and the Finnish Government.

中文翻译：

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等待阑尾切除术期间术前住院延迟对阑尾穿孔的作用（PERFECT）：一项北欧、务实、开放标签、多中心、非劣效性、随机对照试验

阑尾切除术仍然是阑尾炎的标准治疗方法。对于急性单纯性阑尾炎的手术紧迫性尚无国际共识，建议从立即手术到24小时内手术不等。人们认为较长的住院延误会增加穿孔和进一步发病的风险。因此，我们的目的是比较两种不同紧急情况（<8小时<24小时）接受阑尾切除术的患者的阑尾穿孔率。在芬兰两家医院和挪威一家医院进行的这项务实、开放标签、多中心、非劣效性、平行、随机对照试验中，假定患有无并发症急性阑尾炎的患者（年龄≥18岁）被随机分配（1:1）至安排在 8 小时内或 24 小时内进行阑尾切除术，以确定较长的住院延迟（随机分组和手术切口之间的时间）是否不劣于较短的延迟。因妊娠、怀疑阑尾炎穿孔（C反应蛋白水平≥100 mg/L、发热>38·5°C、影像学检查有复杂性阑尾炎体征或临床广泛性腹膜炎）或其他原因而被排除的患者需要及时手术。招募人员是值班外科医生，他们决定进行阑尾切除术。随机化序列是使用区块随机化生成的，区块大小随机变化，并按医院区分层；医生和患者都没有被告知分组情况。主要结局是在所有接受意向性阑尾切除术的患者中分析手术期间诊断出的穿孔性阑尾炎。比较各组之间阑尾炎穿孔发生率的绝对差异。对所有接受阑尾切除术的患者的并发症和其他安全结果进行了分析。使用 5 个百分点的差值来确定非劣效性。该试验已在 () 注册，并已停止计提。2020年5月18日至2022年12月31日期间，对2095名患者进行了资格评估，其中1822名患者被随机分配到安排在8小时（n=914）或24小时（n=908）内的阑尾切除术。随机分组后，1822 名患者中有 19 名 (1%) 因违反方案而被排除。意向治疗分析纳入了 1803 名患者，其中 985 名 (55%) 为男性，818 名 (45%) 为女性。组间阑尾穿孔率相似（分配到 <8 小时组的 907 名患者中的 77 [8%] 和分配到 <24 小时组的 896 名患者中的 81 [9%]；绝对风险差异 0·6% [95% CI –2·1 至 3·2]，p=0·68；风险比 1·065，95% CI 0·790 至 1·435)。30 天内的并发症发生率没有发现显着差异（<8 小时组 907 名患者中的 66 [7%]，<24 小时组 896 名患者中 56 [6%]；差异 –1·0% [– 3·3 至 1·3]；p=0·39），并且在此随访期间没有发生死亡。在推测患有无并发症的急性阑尾炎的患者中，与在 8 小时内安排阑尾切除术相比，在 24 小时内安排阑尾切除术不会增加阑尾穿孔的风险。结果可用于分配手术室资源，例如将夜间阑尾切除术推迟到白天。芬兰医学基金会、玛丽和乔治·埃恩罗斯基金会、赫尔辛基生物医学基金会和芬兰政府。