DIAgnostic iMaging or Observation in Early Equivocal appeNDicitis - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Appendicitis requiring surgery or other intervention
研究概览
简要总结
The aim of the study is to evaluate whether patients with early equivocal appendicitis can be observed instead of immediate diagnostic imaging. Half of the patients are randomly assigned to observation group, while the other half will undergo diagnostic imaging. The hypothesis is that resolving appendicitis is common in these patients. Thus, in observation group there will be fewer patients with appendicitis diagnosis and observation reduces the use of diagnostic imaging and surgery.
详细描述
For the study equivocal appendicitis is defined as clinical suspicion of appendicitis with Adult Appendicitis Score between 11 and 15. The estimated prevalence of appendicitis in such patients is around 50%.
Diagnostic imaging is done using conditional computed tomography i.e. abdominal ultrasound first and computed tomography only after negative or inconclusive appendicitis after ultrasound.
In observation group repeated clinical examination is done after 6-8 hours interval with repeated blood test for calculation of Adult Appendicitis Score. Patients with decreasing score value continue observation without imaging, whereas patients with the same score value or higher (but below 16) undergo diagnostic imaging as in other group. Laparoscopy is done without imaging in patients with high score (16 or higher). Antibiotics are not allowed, but prophylactic antibiotics during induction of anesthesia are allowed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical suspicion of acute appendicitis
- •Equivocal appendicitis defined by Adult Appendicitis Score: Score ≥11 and ≤15.
排除标准
- •C-reactive protein >99 mg/l
- •Time from symptom onset over 24 hours
- •Pregnancy
- •Antibiotics given within last 24 hours
- •Suspicion of other disease than appendicitis, that would require immediate interventions such as surgery, diagnostic imaging or gynecologic consultation
- •Missing written informed consent
- •Patient randomized earlier to the study
研究组 & 干预措施
Observation
Clinical follow-up for at least 6-8 hours, after follow-up repeated laboratory tests and repeated clinical examination is done. Adult Appendicitis Score is calculated after observation to determine further actions. Observation is continued in patients with decreasing score. Patients with the same or higher score undergo diagnostic imaging (score 11-15) or laparoscopy (score 16 or higher). Diagnostic imaging is abdominal ultrasound first and if the result is inconclusive or negative for appendicitis abdominal computed tomography is done. Laparoscopic appendectomy is done for those patients with appendicitis in diagnostic imaging.
干预措施: Observation (Other)
Diagnostic imaging
Patients undergo abdominal ultrasound and if the result is inconclusive or negative for appendicitis patients will have abdominal computed tomography. Laparoscopic appendectomy is done for patients with appendicitis in diagnostic imaging.
干预措施: Diagnostic imaging (Other)
结局指标
主要结局
Appendicitis requiring surgery or other intervention
时间窗: 30 days from randomization
次要结局
- Number of re-admissions to emergency unit(1 year)
- Number of other clinically relevant findings(30 days from randomization)
- Number of diagnostic imaging studies needed(30 days from randomization and within 1 year after randomization)
- Time for decision(30 days from randomization)
- Delayed appendicitis diagnosis(30 days from randomization)
- Appendicitis requiring surgery or other intervention(within 1 year after randomization)
- Complicated appendicitis(30 days from randomization)
- Negative appendectomy(30 days from randomization)
- Number of patients requiring of gynecological consultation(30 days from randomization)
研究者
Panu Mentula
M.D.
Helsinki University Central Hospital