Procalcitonin REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Need to surgery at 30 days after admission
研究概览
简要总结
Diverticular disease is a common disease in developed countries, affecting 2.5 million individuals in the United States (US). Prevalence of diverticula increases with age and goes up to 50 to 66% in patients older than age 80 years. Approximately 10 to 25% of patients with diverticulosis will develop diverticulitis. Acute diverticulitis (AD) accounts for 312,000 admissions and 1.5 million days of inpatient care in the US, where its annual treatment costs exceed 2.6 billion dollars. With the ageing of global population these numbers are expected to rise.
Procalcitonin (PCT) is a biomarker widely used to monitor bacterial infections and guide antibiotic therapy in Intensive Care Units and has been shown to be useful in different surgical fields such as acute appendicitis. Recently, has been demonstrated that PCT and CPR have good predictive value of anastomotic leak (AL) after colorectal surgery.
A multicentric study has been designed to test if PCT, CRP and WBC values might be able to predict the outcomes of patients admitted in emergency setting for acute diverticulitis. In particular if they might distinguish between patients needing only conservative (nothing per os, iv fluids and antibiotics) or interventional therapy such as radiological drain or even surgery, in the aim to optimize and individualize each patients therapy and speed patients discharge.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients admitted for acute diverticulitis in emergency setting
- •with CT scan performed and Hinchey > or = 2
排除标准
- •age < 18 years
- •pregnant women
- •patients with acute diverticulitis without CT scan
- •patients with acute diverticulitis with Hinchey I
结局指标
主要结局
Need to surgery at 30 days after admission
时间窗: 1 year
次要结局
- Need of percutaneous drainage(1 year)
- Length of hospital stay(1 year)
研究者
Valentina Giaccaglia
Valentina Giaccaglia, MD
University of Roma La Sapienza
