Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis (PROSECCO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 4
- 主要终点
- Complicated appendicitis
研究概览
简要总结
The goal of this clinical trial is to compare protocol based selective imaging to routine imaging in adult patients with suspected appendicitis. The main question[s] it aims to answer are:
- Does protocol based selective imaging using clinical scoring affect clinical outcome?
- Does protocol based selective observation combined with score based selective imaging affect clinical outcome?
Participants will be randomized into three groups:
- Selective imaging based on Adult Appendicitis Score
- Selective observation based on Appendicitis Severity Score combined with selective imaging based on Adult Appendicitis Score
- Routine imaging using ultrasound and/or computed tomography
Researchers will compare selective imaging groups separately with routine imaging to see if number of negative appendectomies or number of complicated appendicitis is not significantly increased.
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
- •- Suspicion of appendicitis
排除标准
- •Time from symptom onset over 72 hours
- •Age <18 years
- •Pregnancy, ruled out by serum or urine HCG measurement in 18- to 49-year-old women
- •CT-scan or ultrasound already done within the last 3 days (72 hours)
- •Clinical suspicion of other disease or other reason to perform imaging study
- •Recruited earlier to the same trial
研究组 & 干预措施
Appendicitis Severity Score based observation with selective imaging using Adult Appendicitis Score
Patients with Adult Appendicitis Score (AAS) 10 or less are discharged without imaging studies. Patients with AAS 11 or more are managed based on Appendicitis Severity Score (ASS). ASS is used to identify patients with low risk of complicated disease. Patients with high ASS (>4) are managed as patients in arm 2. Patients with low ASS (<=4) begin observation protocol where patients can leave hospital and they are re-evaluated with repeated scoring after 12-24 hours from randomization. After re-scoring patients may be discharged if AAS is below 16 and decreasing and ASS is below 5 or if AAS is below 11. If AAS is 16 or higher or increasing, patients are scheduled for urgent laparoscopic appendectomy. After observation period, patients with decreasing AAS between 11-15 and ASS higher than 4 or patients with stable AAS between 11-15 are send for imaging study.
干预措施: Score based selective observation combined with selective abdominal imaging (Other)
Routine imaging
Patients will have first abdominal ultrasound, and if findings are negative or inconclusive for appendicitis abdominal CT scan is made. If ultrasound is not available, CT scan can be the first imaging study. If appendicitis is found in the imaging study patient is scheduled for urgent laparoscopic appendectomy. Other patients are discharged or treated according to possible alternative diagnosis.
干预措施: Abdominal imaging (Diagnostic Test)
Adult Appendicitis Score based selective imaging
Adult Appendicitis Score (AAS) is calculated as soon as possible. Patients with AAS 16 or higher are scheduled for urgent laparoscopic appendectomy. Patients with AAS 11- 15 will have abdominal imaging as in the group 1. If appendicitis is found in the imaging study patient is scheduled for urgent laparoscopic appendectomy. Patients with AAS 10 or less are discharged without imaging studies.
干预措施: Score based selective abdominal imaging (Other)
结局指标
主要结局
Complicated appendicitis
时间窗: Within 30 days from randomization
Number of patients with complicated appendicitis (AAST grade 3 or higher)
Negative appendectomy
时间窗: Within 30 days from randomization
Number of negative appendectomies (surgical removal of non-inflamed appendix)
次要结局
- Quality of life (EQ-5D-5L EQ-VAS score)(During the first 30 days from randomization)
- histologically proven appendicitis(Within 30 days from randomization)
- CT scan(Within 30 days from randomization)
- Appendicitis(Within 2 years from randomization)
- Costs in Euros(During the first 30 days from randomization)
- Adverse events(Within one year from randomization)
- Quality of life (EQ-5D-5L index value)(During the first 30 days from randomization)
研究者
Panu Mentula
M.D.
Helsinki University Central Hospital