Prostaglandin-E Urinary Metabolite (PGE-M) as a Predictor of Acute Appendicitis in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KBC Split
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PGE-M
研究概览
简要总结
Diagnosing acute appendicitis in children remains a clinical challenge, with delayed or incorrect diagnosis potentially leading to serious complications or unnecessary surgery. Prostaglandin E urinary metabolites (PGE-M) have been found elevated in various inflammatory conditions, but their diagnostic value in pediatric appendicitis is not well established. This study aims to assess the potential of PGE-M as a biomarker for acute appendicitis in children.
The study will be conducted over 12 months and will include 100 children aged 5 to 17 years presenting with acute abdominal pain. In addition to routine laboratory tests, urinary PGE-M levels will be analyzed. The study involves minimal risk to participants
详细描述
The diagnosis of acute appendicitis in children remains a challenge, even for experienced clinicians. Failure to recognize this acute condition may result in perforation and subsequent peritonitis, whereas misdiagnosis can lead to unnecessary (negative) appendectomies. Elevated levels of prostaglandin E urinary metabolites (PGE-M) have been observed in other inflammatory conditions such as inflammatory bowel disease, acute mesenteric ischemia, and necrotizing enterocolitis.
The aim of this study is to determine whether PGE-M levels are elevated in children with acute appendicitis and whether this biomarker could be used in the diagnosis of acute appendicitis.
The planned duration of the study is 12 months, with a projected sample size of 100 participants.
Inclusion criteria: Children aged 5 to 17 years presenting with acute abdominal pain and signs and symptoms suggestive of acute appendicitis, without significant comorbidities.
Exclusion criteria: Children outside the specified age range, those with a previously diagnosed chronic or malignant disease, a history of abdominal surgery, or pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children of age 5 -17 years with acute abdominal pain
- •children with clinical signs of acute appendicitis
排除标准
- •previous diagnosis of chronic and/or malignant disease
- •children who had previous abdominal surgery
- •pregnancy
结局指标
主要结局
PGE-M
时间窗: 72 hours
Levels of prostaglandin E urinary metabolite as measured with ELISA test
次要结局
未报告次要终点
研究者
Tomislav Žuvela
Doctor of Medicine, Plastic surgery resident
KBC Split