Clinical trial NCT02817854: PCT REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study
Official title: Procalcitonin REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Diverticulitis
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted for acute diverticulitis in emergency setting, with CT scan performed

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.


Eligibility criteria: 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

Primary outcomes:
measure: Need to surgery at 30 days after admission
timeFrame: 1 year
Secondary outcomes:
measure: Need of percutaneous drainage
timeFrame: 1 year
measure: Length of hospital stay
timeFrame: 1 year
Other outcomes:
Locations:
city: Dijon
country: France
facility: Department of Digestive Surgery, University Hospital
city: Milan
country: Italy
facility: General and Emergency Surgery, Niguarda Hospital
city: Rome
country: Italy
facility: Department of Surgical and Medical Sciences and Translational Medicine, General Surgery and Emergency Surgery Units, Sant'Andrea Hospital, 'Sapienza' University of Rome
city: Trieste
country: Italy
facility: Department of Surgery, General Surgery Unit, Azienda Ospedaliero- Universitaria 'Ospedali Riuniti di Trieste'
Study officials:
affiliation: Sant'Andrea University Hospital, Sapienza Univeristy of Rome
name: Valentina Giaccaglia, MD
role: PRINCIPAL_INVESTIGATOR
References: