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PCT REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

NCT ID: NCT02817854

Last Updated: 2016-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-07-31

Brief Summary

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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

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Conditions

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Acute Diverticulitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with acute diverticulitis

Patients admitted in emergency setting for acute diverticulitis

Measure PCT, CRP and WBC at admission

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Measure PCT, CRP and WBC 2 days after admission

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Measure PCT, CRP and WBC 1 day after admission

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

Intervention Type PROCEDURE

Measure PCT, CRP and WBC 2 days after admission

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

Intervention Type PROCEDURE

Other Intervention Names

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PCT: procalcitonin WBC: white blood cell count CRP: C- reactive protein PCT: procalcitonin CRP: C- reactive protein WBC: white blood cell count PCT: procalcitonin CRP: C- reactive protein WBC: white blood cell count

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Valentina Giaccaglia

Valentina Giaccaglia, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Valentina Giaccaglia, MD

Role: PRINCIPAL_INVESTIGATOR

Sant'Andrea University Hospital, Sapienza Univeristy of Rome

Locations

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Department of Digestive Surgery, University Hospital

Dijon, , France

Site Status RECRUITING

General and Emergency Surgery, Niguarda Hospital

Milan, , Italy

Site Status RECRUITING

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

Rome, , Italy

Site Status RECRUITING

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

Trieste, , Italy

Site Status RECRUITING

Countries

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France Italy

Central Contacts

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Valentina Giaccaglia, MD

Role: CONTACT

Phone: +393397882429

Email: [email protected]

Facility Contacts

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Pablo Ortega Deballon, MD

Role: primary

Giovanni Ferrari, MD

Role: primary

Pietro Carnevali, MD

Role: backup

Valentina Giaccaglia, MD

Role: primary

Niccolo de Manzini, MD

Role: primary

Other Identifiers

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PREGRAD

Identifier Type: -

Identifier Source: org_study_id