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CompletedNCT05549076HERCO-IIUpdated Dec 28, 2023

Hellenic Registry for cIAIs (HERCO-II)

An observational study in Intra-abdominal Infection, sponsored by Maximos Frountzas. Completed at 1 site in Greece. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-12-28.

Sponsored by Maximos Frountzas · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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)
02

Conditions studied

  • Intra-abdominal Infection

Keywords

  • complicated
  • intra-abdominal
  • infection
  • greek
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 300 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Maximos Frountzas is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with complicated intra-abdominal infections.

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

Exclusion Criteria:

  1. Age \< 18 years old
  2. No signed consent from patient or authorized representative
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Morbidity

    Overall complications due to complicated intra-abdominal infections

    Time frame: 30 days

Secondary outcomes

  1. Mortality

    Number of deaths due to complicated intra-abdominal infections

    Time frame: 30 days

  2. Length of stay

    Days of hospitalization

    Time frame: 30 days

  3. Length of ICU stay

    Days in the ICU

    Time frame: 30 days

  4. Organ failure

    Dysfunction of one ore more organs

    Time frame: 30 days

  5. Re-operation rate

    Re-operations after first surgical procedure

    Time frame: 30 days

  6. Multidrug resistant pathogen cultures

    Results of pathogen cultures indicating multi-drug resistant variants.

    Time frame: 30 days

07

Study locations

1 site
  • Hippocration General Hospital
    Athens, Greece
08

References and documents

Publications

  • Shrestha B, Dunn L. The Declaration of Helsinki on Medical Research involving Human Subjects: A Review of Seventh Revision. J Nepal Health Res Counc. 2020 Jan 21;17(4):548-552. doi: 10.33314/jnhrc.v17i4.1042. PubMed 32001865 ↗
  • Ahmed S, Wilcox MH, Kirby A. Measuring outcomes in complicated intra-abdominal infections. Curr Opin Gastroenterol. 2020 Jan;36(1):1-4. doi: 10.1097/MOG.0000000000000591. PubMed 31567430 ↗
  • Leone S, Damiani G, Pezone I, Kelly ME, Cascella M, Alfieri A, Pace MC, Fiore M. New antimicrobial options for the management of complicated intra-abdominal infections. Eur J Clin Microbiol Infect Dis. 2019 May;38(5):819-827. doi: 10.1007/s10096-019-03533-y. Epub 2019 Mar 23. PubMed 30903538 ↗
  • Mayumi T, Okamoto K, Takada T, Strasberg SM, Solomkin JS, Schlossberg D, Pitt HA, Yoshida M, Gomi H, Miura F, Garden OJ, Kiriyama S, Yokoe M, Endo I, Asbun HJ, Iwashita Y, Hibi T, Umezawa A, Suzuki K, Itoi T, Hata J, Han HS, Hwang TL, Dervenis C, Asai K, Mori Y, Huang WS, Belli G, Mukai S, Jagannath P, Cherqui D, Kozaka K, Baron TH, de Santibanes E, Higuchi R, Wada K, Gouma DJ, Deziel DJ, Liau KH, Wakabayashi G, Padbury R, Jonas E, Supe AN, Singh H, Gabata T, Chan ACW, Lau WY, Fan ST, Chen MF, Ker CG, Yoon YS, Choi IS, Kim MH, Yoon DS, Kitano S, Inomata M, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: management bundles for acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):96-100. doi: 10.1002/jhbp.519. Epub 2017 Dec 16. PubMed 29090868 ↗
  • Sartelli M, Weber DG, Kluger Y, Ansaloni L, Coccolini F, Abu-Zidan F, Augustin G, Ben-Ishay O, Biffl WL, Bouliaris K, Catena R, Ceresoli M, Chiara O, Chiarugi M, Coimbra R, Cortese F, Cui Y, Damaskos D, De' Angelis GL, Delibegovic S, Demetrashvili Z, De Simone B, Di Marzo F, Di Saverio S, Duane TM, Faro MP, Fraga GP, Gkiokas G, Gomes CA, Hardcastle TC, Hecker A, Karamarkovic A, Kashuk J, Khokha V, Kirkpatrick AW, Kok KYY, Inaba K, Isik A, Labricciosa FM, Latifi R, Leppaniemi A, Litvin A, Mazuski JE, Maier RV, Marwah S, McFarlane M, Moore EE, Moore FA, Negoi I, Pagani L, Rasa K, Rubio-Perez I, Sakakushev B, Sato N, Sganga G, Siquini W, Tarasconi A, Tolonen M, Ulrych J, Zachariah SK, Catena F. 2020 update of the WSES guidelines for the management of acute colonic diverticulitis in the emergency setting. World J Emerg Surg. 2020 May 7;15(1):32. doi: 10.1186/s13017-020-00313-4. PubMed 32381121 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05549076
Lead sponsor
Maximos Frountzas
Responsible party
Maximos Frountzas (Dr Maximos Frountzas MD MPA PhD, National and Kapodistrian University of Athens) — Sponsor-investigator
First posted
Sep 22, 2022
Start date
Oct 1, 2022
Primary completion
Oct 1, 2023
Completion
Dec 25, 2023
Last update
Dec 28, 2023

Study contacts

Konstantinos G Toutouzas, MD PhD
principal investigator · National and Kapodistrian University of Athens

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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