PCT REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

• Conditions: Acute Diverticulitis
• Interventions: 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

• Registration Number: NCT02817854
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-06
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-29
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-06-30
• Primary Completion: 2017-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Need to surgery at 30 days after admission	1 year

Secondary Outcome Measures

Name	Time	Method
Need of percutaneous drainage	1 year
Length of hospital stay	1 year

Trial Locations

Locations (4)

Department of Digestive Surgery, University Hospital; 🇫🇷 Dijon, France

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, Italy