NCT02817854

PCT REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

Procalcitonin REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Diverticulitis

Interventions

Type	Name	Description
PROCEDURE	Measure PCT, CRP and WBC at admission	Measure PCT, CRP and WBC at admission after diagnosis of acute diverticulitis with CT scan has been done
PROCEDURE	Measure PCT, CRP and WBC 1 day after admission	Measure PCT, CRP and WBC at one day after admission for acute diverticulitis
PROCEDURE	Measure PCT, CRP and WBC 2 days after admission	Measure PCT, CRP and WBC at 2 days after admission for acute diverticulitis

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-06-01
• Completion: 2017-07-01
• First posted: 2016-06-29
• Last updated: 2016-06-30

Locations

4 sites across 2 countries: France, Italy