Optimized Treatment for Uncomplicated Acute Appendicitis; Active Observation With or Without Antibiotic Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Number of participants with no symptom relief
研究概览
简要总结
This study evaluates if early provision of antibiotics is a superior treatment compared to "traditional wait and see" with regard to symptom relief for suspected acute uncomplicated appendicitis.
详细描述
Recent long-term follow up results of antibiotic treatment of acute appendicitis in unselected populations indicate that approximately 70-80 % of patients respond to antibiotics, while the remaining 20-25% need an operation. Antibiotic treatment was associated with significantly fewer severe and non-severe complications compared to surgery. Therefore, antibiotic treatment can be regarded as safe and effective initial treatment of acute appendicitis based on evidence.
However, it remains to be evaluated to what extent antibiotic treatment is more effective compared to the most conservative application of procedures in the care of patients with acute appendicitis. A well- recognized approach in Sweden is watchful waiting at in-hospital conditions. A certain number of patients with suspected uncomplicated appendicitis will likely recover without any active treatment, but controlled evidence are lacking to what extent such recoveries may occur in the short- and long-term perspective.
The hypothesis is that antibiotic treatment is superior to active observation with regard to symptom relief at suspected acute appendicitis in selected patient groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with suspected appendicitis.
- •Age<60 years.
- •C-reactive protein < 60 mg/L.
- •White blod cell Count (leucocytes) < 13 e9 /L.
- •Exclusion criteria:
排除标准
- 未提供
研究组 & 干预措施
Antibiotic treatment
Patients will receive in-hospital intravenous antibiotics (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3). Surgery if no symptom relif occur.
干预措施: Antibiotic treatment (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3). (Drug)
Clinical observation
Patients are followed by in-hospital "Active observation" (watchful waiting) according to clinical routine. Patients are observed until either, recovery and dismissal from hospital, or decision for intervention (surgery) is taken.
干预措施: Active observation (Other)
结局指标
主要结局
Number of participants with no symptom relief
时间窗: 48 hours
No symptom relief and surgery is deemed necessary.
次要结局
未报告次要终点