PCT REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

NCT02817854 | Unknown

• 1 other identifier: PREGRAD
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 4

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.

Conditions

Acute Diverticulitis

Outcome Measures

Primary Outcomes (1)

• Need to surgery at 30 days after admission

  1 year

Secondary Outcomes (2)

• Need of percutaneous drainage

  1 year

• Length of hospital stay

  1 year

Study Arms (1)

Patients with acute diverticulitis

Patients admitted in emergency setting for acute diverticulitis

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

Interventions

Measure PCT, CRP and WBC at admission PROCEDURE

Measure PCT, CRP and WBC at admission after diagnosis of acute diverticulitis with CT scan has been done

Also known as: PCT: procalcitonin, WBC: white blood cell count, CRP: C- reactive protein

Patients with acute diverticulitis

Measure PCT, CRP and WBC 1 day after admission PROCEDURE

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

Also known as: PCT: procalcitonin, CRP: C- reactive protein, WBC: white blood cell count

Patients with acute diverticulitis

Measure PCT, CRP and WBC 2 days after admission PROCEDURE

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

Also known as: PCT: procalcitonin, CRP: C- reactive protein, WBC: white blood cell count

Patients with acute diverticulitis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted for acute diverticulitis in emergency setting, with CT scan performed

You may qualify if:

• all patients admitted for acute diverticulitis in emergency setting
• with CT scan performed and Hinchey \> or = 2

You may not qualify if:

• age \< 18 years
• pregnant women
• patients with acute diverticulitis without CT scan
• patients with acute diverticulitis with Hinchey I

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (4)

Department of Digestive Surgery, University Hospital

Dijon, France

RECRUITING

General and Emergency Surgery, Niguarda Hospital

Milan, Italy

RECRUITING

Department of Surgical and Medical Sciences and Translational Medicine, General Surgery and Emergency Surgery Units, Sant'Andrea Hospital, 'Sapienza' University of Rome

Rome, 00189, Italy

RECRUITING

Department of Surgery, General Surgery Unit, Azienda Ospedaliero- Universitaria 'Ospedali Riuniti di Trieste'

Trieste, Italy

RECRUITING

MeSH Terms

Interventions

Leukocyte Count; C-Reactive Protein

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Acute-Phase Proteins; Blood Proteins; Immunoproteins

Study Officials

• Valentina Giaccaglia, MD

  Sant'Andrea University Hospital, Sapienza Univeristy of Rome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina Giaccaglia, MD

CONTACT

+393397882429; v.giaccaglia@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Valentina Giaccaglia, MD

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: June 30, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); IT (3)