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Recruiting NCT07130656

AI Algorithm for Surveillance of Deep Surgical Site Infections After Elective Colorectal Surgery.

Observational Surgical Site Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diagnosis of SSI.
Who it may be relevant to
Registry conditions: Surgical Site Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Novel AI Algorithm With Enhanced Accuracy for Surveillance of Deep Surgical Site Infections After Elective Colorectal Surgery. A Diagnostic Accuracy Study.

Overview

Epidemiological surveillance is one of the eight core components of the World Health Organization Infection Prevention and Control Programmes. These include surveillance programmes for surgical site infection (SSI). At present, for SSI surveillance, infection control teams perform a manual time-consuming work, which could make a transition to automated surveillance leveraging the new information technology. The aim of this study was to evaluate the performance of a novel algorithm to detect SSI in a cohort of elective colorectal surgery patients who have been previously screened within a nationwide healthcare-associated infection surveillance system.

Detailed description

Healthcare-associated infections (HAIs) have a negative impact on patient health, represent a significant healthcare and economic burden on healthcare systems and are considered the most preventable cause of serious adverse events in hospitalised patients.

Epidemiological surveillance is one of the eight core components of the World Health Organization (WHO) Infection Prevention and Control Programmes. These include surveillance programmes for surgical site infection (SSI), which have proven to be effective in all types of surgery and in a variety of settings.

For a programme to be effective, surveillance for HCAIs must be active, prospective and continuous, comprising a surveillance period up to 30-90 days post-intervention, to cover the high rate of SSIs detected after discharge.

At present, infection control teams perform a manual, prospective, time-consuming and almost artisanal work, which should make a transition to automated or semi-automated surveillance that leverages the possibilities offered by today\'s information technology.

The evolution of surveillance systems should benefit from this new possibilities offered by artificial intelligence, allowing automated detection of suspected SSI adverse events from clinical course text, microbiology reports or coding of diagnoses, procedures, complications and readmissions.

The aim of this study was to evaluate the performance of a novel algorithm to detect to detect SSI at its three anatomical levels, in a cohort of elective colorectal surgery patients who have been previously screened within a nationwide healthcare-associated infection surveillance system.

Interventions

  • Diagnostic test Diagnosis of SSI
    Diagnosis of SSI by manual system in colorectal surgery procedures enrolled in the SSI surveillance programme.

Primary outcome measures

  • Rate of surgical site infection [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • Elective colorectal resection

Exclusion criteria

  • Emergency surgery
  • Infection present at operation
  • Previous intestinal stoma

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Hospital General de Granollers — Granollers

Publications

  • Casanova-Portoles D, Badia JM, Forero CG, Sanchez-Martinez N, Romero M, Alonso-Solis T, Limon E, Pujol M, Sancho J. A structured-data algorithm for semiautomated surveillance of surgical site infection after colorectal surgery: A diagnostic accuracy study. J Infect Public Health. 2026 Apr;19(4):103151. doi: 10.1016/j.jiph.2026.103151. Epub 2026 Jan 15. PMID 41637931

Identifiers

NCT: NCT07130656 · Infect-IA-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗