PCT REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study (PREGRAD)

June 29, 2016 updated by: Valentina Giaccaglia, University of Roma La Sapienza

Procalcitonin REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
  • Italy
      • Milan, Italy
      • Rome, Italy, 00189
        • Recruiting
        • Department of Surgical and Medical Sciences and Translational Medicine, General Surgery and Emergency Surgery Units, Sant'Andrea Hospital, 'Sapienza' University of Rome
        • Contact:
        • Principal Investigator:
          • Valentina Giaccaglia, MD
      • Trieste, Italy
        • Recruiting
        • Department of Surgery, General Surgery Unit, Azienda Ospedaliero- Universitaria 'Ospedali Riuniti di Trieste'
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with acute diverticulitis
Patients admitted in emergency setting for acute diverticulitis
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
Other Names:
  • PCT: procalcitonin
  • WBC: white blood cell count
  • CRP: C- reactive protein
Procedure: Measure PCT, CRP and WBC 1 day after admission
Measure PCT, CRP and WBC at one day after admission for acute diverticulitis
Other Names:
  • PCT: procalcitonin
  • WBC: white blood cell count
  • CRP: C- reactive protein
Procedure: Measure PCT, CRP and WBC 2 days after admission
Measure PCT, CRP and WBC at 2 days after admission for acute diverticulitis
Other Names:
  • PCT: procalcitonin
  • WBC: white blood cell count
  • CRP: C- reactive protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Need to surgery at 30 days after admission
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: 1 year
1 year
Need of percutaneous drainage
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Principal Investigator: Valentina Giaccaglia, MD, Sant'Andrea University Hospital, Sapienza Univeristy of Rome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREGRAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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