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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02817854
Other study ID # PREGRAD
Secondary ID
Status Recruiting
Phase N/A
First received June 27, 2016
Last updated June 29, 2016
Start date May 2016
Est. completion date July 2017

Study information

Verified date June 2016
Source University of Roma La Sapienza
Contact Valentina Giaccaglia, MD
Phone +393397882429
Email v.giaccaglia@gmail.com
Is FDA regulated No
Health authority Comitato Etico, Azienda Ospedaliera Sant'Andrea: 'Italy'
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date July 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 100 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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
Measure PCT, CRP and WBC 1 day after admission
Measure PCT, CRP and WBC at one day after admission for acute diverticulitis
Measure PCT, CRP and WBC 2 days after admission
Measure PCT, CRP and WBC at 2 days after admission for acute diverticulitis

Locations

Country Name City State
France Department of Digestive Surgery, University Hospital Dijon
Italy General and Emergency Surgery, Niguarda Hospital Milan
Italy Department of Surgical and Medical Sciences and Translational Medicine, General Surgery and Emergency Surgery Units, Sant'Andrea Hospital, 'Sapienza' University of Rome Rome
Italy Department of Surgery, General Surgery Unit, Azienda Ospedaliero- Universitaria 'Ospedali Riuniti di Trieste' Trieste

Sponsors (1)

Lead Sponsor Collaborator
University of Roma La Sapienza

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Need to surgery at 30 days after admission 1 year No
Secondary Need of percutaneous drainage 1 year No
Secondary Length of hospital stay 1 year No
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