跳至主要内容
临床试验/NCT02817854
NCT02817854Unknown不适用

Procalcitonin REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

University of Roma La Sapienza4 个研究点 分布在 2 个国家目标入组 500 人开始时间: 2016年5月最近更新:
适应症

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

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

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Valentina Giaccaglia

Valentina Giaccaglia, MD

University of Roma La Sapienza

研究点 (4)

Loading locations...

相似试验