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PCT REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

Procalcitonin REveals Good Recovery After Acute Diverticulitis: the PREGRAD Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02817854
Acronym
PREGRAD
Enrollment
500
Registered
2016-06-29
Start date
2016-05-31
Completion date
2017-07-31
Last updated
2016-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Diverticulitis

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.

Interventions

PROCEDUREMeasure PCT, CRP and WBC at admission

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

PROCEDUREMeasure PCT, CRP and WBC 1 day after admission

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

PROCEDUREMeasure PCT, CRP and WBC 2 days after admission

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

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Need to surgery at 30 days after admission1 year

Secondary

MeasureTime frame
Need of percutaneous drainage1 year
Length of hospital stay1 year

Countries

France, Italy

Contacts

Primary ContactValentina Giaccaglia, MD
v.giaccaglia@gmail.com+393397882429

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026