PCT REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

Acute Diverticulitis Clinical Trial

— PREGRAD  

Official title:

Procalcitonin REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02817854
• Other study ID #: PREGRAD
• 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

• Acute Diverticulitis
• Diverticulitis

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