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Hellenic Registry for cIAIs (HERCO-II)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05549076
Acronym
HERCO-II
Enrollment
300
Registered
2022-09-22
Start date
2022-10-01
Completion date
2023-12-25
Last updated
2023-12-28

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

Conditions

Intra-abdominal Infection

Keywords

complicated, intra-abdominal, infection, greek

Brief summary

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

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)

Interventions

None listed

Sponsors

Maximos Frountzas
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years

Inclusion criteria

1. Age ≥ 18 years old 2. Signed consent from patient or authorized representative 3. 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

1. Age \< 18 years old 2. No signed consent from patient or authorized representative

Design outcomes

Primary

MeasureTime frameDescription
Morbidity30 daysOverall complications due to complicated intra-abdominal infections

Secondary

MeasureTime frameDescription
Re-operation rate30 daysRe-operations after first surgical procedure
Multidrug resistant pathogen cultures30 daysResults of pathogen cultures indicating multi-drug resistant variants.
Organ failure30 daysDysfunction of one ore more organs
Length of stay30 daysDays of hospitalization
Length of ICU stay30 daysDays in the ICU
Mortality30 daysNumber of deaths due to complicated intra-abdominal infections

Countries

Greece

Outcome results

None listed

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