Hellenic Registry for cIAIs (HERCO-II)

NCT05549076 | Completed

• 1 other identifier: HERCO-II 2022
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Intra-abdominal Infection

Keywords

complicated; intra-abdominal; infection; greek

Outcome Measures

Primary Outcomes (1)

• Morbidity

  Overall complications due to complicated intra-abdominal infections

  30 days

Secondary Outcomes (6)

• Mortality

  30 days

• Length of stay

  30 days

• Length of ICU stay

  30 days

• Organ failure

  30 days

• Re-operation rate

  30 days

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with complicated intra-abdominal infections.

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years old
• No signed consent from patient or authorized representative

Sponsors & Collaborators

• Maximos Frountzas: lead

Study Sites (1)

Hippocration General Hospital

Athens, Greece

Location

Related Publications (5)

• 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.

  PMID: 32001865 BACKGROUND

• 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.

  PMID: 31567430 BACKGROUND

• 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.

  PMID: 30903538 BACKGROUND

• 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.

  PMID: 29090868 BACKGROUND

• 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.

  PMID: 32381121 BACKGROUND

MeSH Terms

Conditions

Intraabdominal Infections; Infections

Study Officials

• Konstantinos G Toutouzas, MD PhD

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Maximos Frountzas MD MPA PhD

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: September 22, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 25, 2023
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

GR (1)