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Status unknownNCT03678298IRCAUpdated Sep 19, 2018

Italian Register for the Study of Complicated Intra-Abdominal Infections

An observational study in Complicated Intra-abdominal Infections, sponsored by World Society of Emergency Surgery. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2018-09-19.

Sponsored by World Society of Emergency Surgery · Observational

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 110 Years
Sex
All
01

Study summary

The study will identify the epidemiological and treatment profiles of acute peritonitis in Italy

Read the detailed description

The primary objectives of the study are: (1) the identification of specific risk factors for in-hospital mortality, in order to perfect the clinical management of patients with complicated intra-abdominal infections (cIAIs); (2) the identification of specific risk factors for multi-drug resistant organisms (MDROs) isolation in patients with cIAIs, in order to improve the adequacy of empirical antimicrobial therapy.

The secondary objectives are: (1) the description of the clinical, diagnostic and treatment profiles of patients with cIAIs in Italian surgical departments; (2) the analysis of epidemiology and patterns of antimicrobial susceptibility of the microorganisms isolated in samples in intra-operative samples of peritoneal fluid or purulent exudate/discrete abscesses in patients with cIAIs; (3) the identification of specific risk factors for post-operative complications in patients with cIAIs.

02

Conditions studied

  • Complicated Intra-abdominal Infections
03

In context

Intraabdominal Infections

129 studies on the registry are indexed under Intraabdominal Infections; 15 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 174 across 48 observational studies indexed under Intraabdominal Infections.

Browse Intraabdominal Infections studies →

Lead sponsor

World Society of Emergency Surgery is the lead sponsor of 2 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 110 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

All patients with complicated intra-abdominal infections

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All consecutively hospitalized adult patients (older than 18 years of age) undergoing surgery, interventional drainage or conservative treatment, with diagnosis of cIAIs (defined as abdominal infections originating in an organ cavity, extending into the peritoneal space, and forming an abscess or peritonitis)

Exclusion criteria

Exclusion Criteria:

Patients younger than 16 years-old, patients with pancreatitis or primary peritonitis

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples without dna

Interventions

  • OtherEpidemiological/treatment profiles

    All consecutively hospitalized adult patients (older than 18 years of age) undergoing surgery, interventional drainage or conservative treatment, with diagnosis of cIAIs (defined as abdominal infections originating in an organ cavity, extending into the peritoneal space, and forming an abscess or peritonitis, will be included in the study.

06

What researchers measure

Primary outcomes

  1. Mortality rates linked to different sources of infection

    Time frame: 12 months

  2. Mortality rates linked to different bacteria causing infection

    Time frame: 12 months

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03678298
Lead sponsor
World Society of Emergency Surgery
Responsible party
Massimo Sartelli (Medical Doctor, World Society of Emergency Surgery) — Principal investigator
First posted
Sep 19, 2018
Start date
Jan 1, 2019 (estimated)
Primary completion
Jan 1, 2020 (estimated)
Completion
Apr 1, 2020 (estimated)
Last update
Sep 19, 2018

Study contacts

Massimo Sartelli, MD
Contact
massimosartelli@gmail.com
00393405369701
Fausto Catena, MD
Contact
faustocatena@gmail.com
Massimo Sartelli, MD
principal investigator · WSES

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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