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

NCT ID: NCT07130656

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-10-30

Brief Summary

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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

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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.

Conditions

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Surgical Site Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients assessed for SSI using the standard manual surveillance method

Patients undergoing colorectal surgery enrolled in the nationwide SSI surveillance programme and assessed for SSI using the standard manual surveillance method.

Diagnosis of SSI

Intervention Type DIAGNOSTIC_TEST

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

Patients assessed for SSI by an algorithm

Patients undergoing colorectal surgery enrolled in the nationwide SSI surveillance programme and assessed for SSI using the new algorithm

Diagnosis of SSI

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Diagnosis of SSI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Elective colorectal resection

Exclusion Criteria

* Emergency surgery
* Infection present at operation
* Previous intestinal stoma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Granollers

OTHER

Sponsor Role lead

Responsible Party

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Josep M Badia

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diana Navarro, PhD

Role: STUDY_CHAIR

Hospital General de Granollers

Locations

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Hospital General de Granollers

Granollers, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Josep M Badia, MD, PhD

Role: CONTACT

670702099

Facility Contacts

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Josep M Badia

Role: primary

670702099

Other Identifiers

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Infect-IA-2

Identifier Type: -

Identifier Source: org_study_id

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