Antibiotics vs.Surgery in Acute Appendicitis;an Intention to Treat Prospective Randomised Study. The ASAA-study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- the rate of patients free of symptoms into 2 weeks (from operation in the surgery group or from the third Ertapenem administration in the antibiotics group) with no pain, no fever, WBC ≤ 10000, CRP ≤ 1
研究概览
简要总结
The acute appendicitis (AA) is a very common disease with a life time risk 7-8% and the highest incidence in the second decades . The aetiology of AA is still poor understood: the commonest hypothesis refers to appendix obstruction followed by impairment of wall appendix barrier and thus wall perforation and/or abscess formation1. However some studies suggest that no-complicate and complicate appendicitis are different entities allowing a different treatment. The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients between 18 and 65 years old
- •first episode of suspected AA diagnosed by Andersson's score or combination with abdominal ultrasound
排除标准
- •patients with any potential immunodeficiency status
- •assumption of antibiotics for different infectious disease or surgery in the last 30 days
- •allergy to antibiotics established in the study protocol
- •no acceptance of study protocol
- •pregnancy or delivery in the last 6 months
- •ASA IV or V, no Italian or English fluently speakers.
研究组 & 干预措施
Ertapenem
干预措施: Ertapenem (Drug)
appendectomy
Appendectomy is compared to Ertapenem
干预措施: appendectomy (Procedure)
结局指标
主要结局
the rate of patients free of symptoms into 2 weeks (from operation in the surgery group or from the third Ertapenem administration in the antibiotics group) with no pain, no fever, WBC ≤ 10000, CRP ≤ 1
时间窗: 2 weeks
次要结局
- Secondary outcomes will be considered major complications occurring after 2 weeks and into 1 year. Phone consultation will be performed at 1 year(2 weeks- One year)
研究者
Michele Pisano
Medical Doctor
A.O. Ospedale Papa Giovanni XXIII