Hellenic Registry for cIAIs (HERCO-II)

Study Overview
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Brief Summary
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Complicated Intra-Abdominal Infections (cIAIs) represent an emergent surgical situation which lead to important non trauma-related mortality in several Emergency Surgical Centers worldwide. Their prevalence seemed to be unrelated to age, gender, health status and socioeconomic condition. Early diagnosis, timely septic source control, wide-spectrum antibiotic delivery and resuscitation with fluids and vasoactive agents in critically ill patients are fundamentals for successful cIAIs management. Moreover, septic shock, antibiotic resistant multi-pathogens and comorbidities have been associated with increased morbidity and mortality of cIAIs. Several international health associations announce updated guidelines for cIAIs management. Nevertheless, such guidelines could not be widely implemented, because of specific features of several healthcare systems worldwide. The aim of the present study is to investigate the prevalence of cIAIs among the Greek health system and the potential association of time interval of septic source control, preoperative resuscitation and multidrug resistant pathogens with morbidity, mortality, ICU stay and length of stay in patients with cIAIs.

Detailed Description
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Registry of patients with complicated intra-abdominal infections including: Patient demographics (gender, age, Carlson Comorbidity Index, cancer history/chemotherapy during the last 6 months, health unit stay during the last 6 months) Management (conservative, minimally invasive, surgical) Minimally invasive procedure - type (CT-guided drainage, endoscopic) Surgical procedure - type (open or laparoscopic, day or night, procedure description) Cultures (blood, peritoneal fluid, tissue) Time of diagnosis (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, temperature, white cell count, CRP) Just before procedure (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, vasoactive agent delivery, intubation) Intraoperative parameters (time interval between diagnosis and intervention, WSES score, operative time, open abdomen, VAC) After procedure (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, temperature, vasoactive agent delivery, intubation) Empirical wide-spectrum antibiotics (type and time interval from diagnosis)

Official Title
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Complicated Intra-abdominal Infections - the Greek Reality: a Prospective Observational Study

Conditions
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Intra-abdominal Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Signed consent from patient or authorized representative Complicated Intra-Abdominal Infection Acute appendicitis with localized or diffuse peritonitis Grade II or Grade III acute cholecystitis (Tokyo guidelines) Visceral organ perforation with peritonitis Bowel perforation after colonoscopy Complicated diverticulitis (WSES classification) Anastomotic leaks with abscess, localized or diffuse peritonitis Exclusion Criteria: Age < 18 years old No signed consent from patient or authorized representative

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Overall complications due to complicated intra-abdominal infections | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Number of deaths due to complicated intra-abdominal infections | 30 days | 
| Length of stay | Days of hospitalization | 30 days | 
| Length of ICU stay | Days in the ICU | 30 days | 
| Organ failure | Dysfunction of one ore more organs | 30 days | 
| Re-operation rate | Re-operations after first surgical procedure | 30 days | 
| Multidrug resistant pathogen cultures | Results of pathogen cultures indicating multi-drug resistant variants. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complicated, intra-abdominal, infection, greek