Non-operative Management of Early Appendicitis in Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Failure of Non-operative management
研究概览
简要总结
The purpose of this study is to determine the feasibility of non-operative management of early appendicitis in children. We hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up.
详细描述
Non-operative management of appendicitis with antibiotics alone has recently emerged as a viable treatment alternative to appendectomy. There have been several clinical trials in adults which conclude that antibiotics alone are a safe initial treatment for appendicitis; none of these studies included children.
The primary objective of this study is to determine: conversion to surgery (failure of nonoperative management), 30 day, 6 month and 1 year recurrence rate of appendicitis in children treated with non-operative management. Recurrence is defined as need for appendectomy. The secondary objective is to compare adverse outcomes, length of stay, days to return to school, costs of care and quality of life measures between the study group and those that receive standard of care.We hypothesize that non-operative management of early appendicitis in children with antibiotics alone will be successful in 80% of children at 1 year follow-up.
This is a prospective, non-randomized single-site trial measuring the feasibility of treating children (7-17 years old) with early appendicitis with antibiotics only (non-operative management). There will be two cohorts; those who agree to receive non-operative management (Non-Operative Group) and those that permit us to track their standard treatment course (Surgery Group).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Ultrasound (US) or CT scan confirmed early appendicitis (US: hyperemia, <1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon; CT: hyperemia, fat stranding, <1.1 cm in diameter, no abscess, no fecalith, no phlegmon)
- •White blood cell count (WBC) < 15,000
- •C reactive protein (CRP) <4 (if obtained)
- •Focal abdominal pain </= 36 hours prior to receiving antibiotics
排除标准
- •English is not the primary language of either the child or parent/guardian
- •Other significant co-morbidities: cardiovascular disease, malignancy, pulmonary disease, diabetes, obesity (BMI ≥ 95th percentile for age and sex), severe developmental delay
- •Positive urine pregnancy test
- •Diffuse peritonitis
- •History of chronic intermittent abdominal pain
- •WBC >/= 15
- •CRP>/= 4 (if obtained)
- •Pain > 36 hours prior to first antibiotic dose or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon
结局指标
主要结局
Failure of Non-operative management
时间窗: 1 year
The primary endpoints are: conversion to surgery (failure of nonoperative management), 30-day, 6 month and one year recurrence rate.
次要结局
- Adverse Outcomes(1 year)
研究者
Peter Minneci
Principal Investigator
Nationwide Children's Hospital