Role of preoperative in-hospital delay on appendiceal perforation while awaiting appendicectomy (PERFECT): a Nordic, pragmatic, open-label, multicentre, non-inferiority, randomised controlled trial

医学 穿孔 外科 阑尾炎 随机对照试验 附录 普通外科 生物 古生物学 冶金 材料科学 冲孔
作者
Karoliina Jalava,Ville Sallinen,Hanna Lampela,Hanna Malmi,Ingeborg Haug Steinholt,Knut Magne Augestad,Ari Leppäniemi,Panu Mentula
出处
期刊:The Lancet [Elsevier BV]
卷期号:402 (10412): 1552-1561 被引量:19
标识
DOI:10.1016/s0140-6736(23)01311-9
摘要

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 vs <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 ClinicalTrials.gov (NCT04378868) 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 vs 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.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
刚刚
虚心的惮完成签到 ,获得积分10
1秒前
Frank完成签到 ,获得积分10
1秒前
烂漫人达完成签到 ,获得积分10
2秒前
Liang完成签到,获得积分10
3秒前
TC发布了新的文献求助10
4秒前
传奇3应助枕星采纳,获得10
4秒前
凡凡发布了新的文献求助10
5秒前
免疫与代谢研究完成签到,获得积分10
6秒前
jiajiajai发布了新的文献求助10
7秒前
西早07完成签到,获得积分10
7秒前
Meng完成签到,获得积分10
8秒前
Neo完成签到,获得积分10
9秒前
keyaner完成签到,获得积分10
11秒前
童林艳完成签到,获得积分10
11秒前
ECHO完成签到,获得积分10
13秒前
Lucas应助Fang Xianxin采纳,获得10
14秒前
xiaoyao完成签到,获得积分10
15秒前
asss完成签到,获得积分10
15秒前
Y123发布了新的文献求助30
16秒前
LOVER完成签到 ,获得积分10
17秒前
松松完成签到 ,获得积分10
17秒前
19秒前
nater4ver完成签到,获得积分10
20秒前
UU发布了新的文献求助10
22秒前
超帅鸭子完成签到,获得积分10
22秒前
LXZ完成签到,获得积分10
22秒前
依惜完成签到,获得积分10
22秒前
zhaokunfeng关注了科研通微信公众号
22秒前
赫青亦完成签到 ,获得积分10
22秒前
exy完成签到,获得积分10
23秒前
zhaohu47完成签到,获得积分10
24秒前
超帅鸭子发布了新的文献求助10
24秒前
每每反完成签到,获得积分10
26秒前
凡凡完成签到 ,获得积分10
27秒前
28秒前
呆鹅喵喵完成签到,获得积分10
28秒前
忧心的洙完成签到,获得积分10
29秒前
123完成签到,获得积分10
29秒前
青青草完成签到,获得积分10
31秒前
高分求助中
【提示信息,请勿应助】关于scihub 10000
Les Mantodea de Guyane: Insecta, Polyneoptera [The Mantids of French Guiana] 3000
徐淮辽南地区新元古代叠层石及生物地层 3000
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
Handbook of Industrial Diamonds.Vol2 1100
Global Eyelash Assessment scale (GEA) 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 550
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 4038303
求助须知:如何正确求助?哪些是违规求助? 3576013
关于积分的说明 11374210
捐赠科研通 3305780
什么是DOI,文献DOI怎么找? 1819322
邀请新用户注册赠送积分活动 892672
科研通“疑难数据库(出版商)”最低求助积分说明 815029