PCT REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

Study Overview
=================
Brief 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.

Official Title
-----------------
Procalcitonin REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

Conditions
-----------------
Acute Diverticulitis

Intervention / Treatment
-----------------
* Procedure: Measure PCT, CRP and WBC at admission
* Procedure: Measure PCT, CRP and WBC 1 day after admission
* Procedure: Measure PCT, CRP and WBC 2 days after admission


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with acute diverticulitis<br>Patients admitted in emergency setting for acute diverticulitis | Procedure: Measure PCT, CRP and WBC at admission<br>* Measure PCT, CRP and WBC at admission after diagnosis of acute diverticulitis with CT scan has been done<br>* Other names: CRP: C- reactive protein;Procedure: Measure PCT, CRP and WBC 1 day after admission<br>* Measure PCT, CRP and WBC at one day after admission for acute diverticulitis<br>* Other names: WBC: white blood cell count;Procedure: Measure PCT, CRP and WBC 2 days after admission<br>* Measure PCT, CRP and WBC at 2 days after admission for acute diverticulitis<br>* Other names: WBC: white blood cell count;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need to surgery at 30 days after admission |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of percutaneous drainage |  | 1 year | 
| Length of hospital stay |  | 1 year |