Antibiotic therapy vs. placebo in the treatment of acute uncomplicated appendicitis: a prospective randomized double-blind placebo-controlled trial - APPAC III
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 5
- 主要终点
- The primary endpoint is the success of the randomized treatment (treatment efficacy). The treatment success is defined as the resolution of acute appendicitis with study treatment resulting in discharge from the hospital without the need for surgical intervention and treatment efficacy evaluated at ten days after initiation of the randomized treatment.
研究概览
简要总结
The aim of the study is to compare antibiotic therapy with placebo in the treatment of uncomplicated acute appendicitis to evaluate the role of antibiotic therapy in the resolution of acute uncomplicated appendicitis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent, 2) Age 18 – 60 years, 3) CT scan confirmed diagnosis of uncomplicated acute appendicitis.
排除标准
- •Age <18 or > 60 years, 2) Pregnancy or lactating, 3) Allergy to contrast media or iodine, 4) Renal insufficiency, 5) Allergy or contraindication to antibiotic therapy 6) Metformine medication, 7) Severe systemic illness (for example malignancy, medical condition requiring immunosuppressant medications), 8) Complicated acute appendicitis in a CT scan (appendicolith, perforation, abscess, suspicion of a tumor), 9) Inability to co-operate and give informed consent.
结局指标
主要结局
The primary endpoint is the success of the randomized treatment (treatment efficacy). The treatment success is defined as the resolution of acute appendicitis with study treatment resulting in discharge from the hospital without the need for surgical intervention and treatment efficacy evaluated at ten days after initiation of the randomized treatment.
The primary endpoint is the success of the randomized treatment (treatment efficacy). The treatment success is defined as the resolution of acute appendicitis with study treatment resulting in discharge from the hospital without the need for surgical intervention and treatment efficacy evaluated at ten days after initiation of the randomized treatment.
次要结局
- Secondary endpoints include post-intervention complications (Clavien-Dindo classification), late recurrence of acute appendicitis after study treatment defined as clear clinical suspicion of acute appendicitis evaluated at follow-up of one, three, five and ten years, duration of hospital stay, VAS scores, quality of life (QOL, 15D), sick leave and treatment costs.
研究者
Paulina Salminen
Scientific
Turku University Hospital