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PCT REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

U

University of Roma La Sapienza

Status

Unknown

Conditions

Acute Diverticulitis

Treatments

Procedure: Measure PCT, CRP and WBC 1 day after admission
Procedure: Measure PCT, CRP and WBC at admission
Procedure: Measure PCT, CRP and WBC 2 days after admission

Study type

Observational

Funder types

Other

Identifiers

NCT02817854
PREGRAD

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • all patients admitted for acute diverticulitis in emergency setting
  • with CT scan performed and Hinchey > or = 2

Exclusion criteria

  • age < 18 years
  • pregnant women
  • patients with acute diverticulitis without CT scan
  • patients with acute diverticulitis with Hinchey I

Trial design

500 participants in 1 patient group

Patients with acute diverticulitis
Description:
Patients admitted in emergency setting for acute diverticulitis
Treatment:
Procedure: Measure PCT, CRP and WBC 2 days after admission
Procedure: Measure PCT, CRP and WBC at admission
Procedure: Measure PCT, CRP and WBC 1 day after admission

Trial contacts and locations

4

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Central trial contact

Valentina Giaccaglia, MD

Data sourced from clinicaltrials.gov

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