Non-operative Management of Uncomplicated Appendicitis With an Appendicolth in Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of Participants That Did Not Have an Appendectomy
研究概览
简要总结
To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.
详细描述
This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 7-17 years
- •Abdominal pain </= 48hours prior to receiving antibiotics
- •White Blood Cell Count >5 but < 18
- •US or CT confirmed early appendicitis plus:
- •US: </=1.1 cm in diameter, presence of appendicolith
- •CT: </= 1.1cm in diameter, presence of appendicolith
排除标准
- •Positive urine pregnancy test
- •Pain > 48 hours prior to first antibiotic dose
- •Diffuse peritonitis
- •History of chronic intermittent abdominal pain
- •White Blood Cell count ≤ 5 or ≥ 18
- •Absence of appendicolith or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon
研究组 & 干预措施
Non-operative Management
Non-operative management with antibiotics only Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic
干预措施: Antibiotics only (Zosyn then Augmentin) (Drug)
结局指标
主要结局
Number of Participants That Did Not Have an Appendectomy
时间窗: 1 year
Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge
次要结局
- Number of Participants With Complicated Appendicitis(1 year)
研究者
Peter Minneci
Principal Investigator
Nationwide Children's Hospital