ChatGPT-4 for Surgical Site Infection Detection From Electronic Health Records After Colorectal Surgery. (Infect-IA-3)

August 12, 2025 updated by: Josep M Badia, Hospital de Granollers

Evaluation of ChatGPT-4 for the Detection of Surgical Site Infections From Electronic Health Records After Colorectal Surgery: A Diagnostic Accuracy Study.

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.

This study aimed to evaluate the ability of ChatGPT-4o to detect surgical site infection at the three anatomical levels.

Study Overview

Status

Recruiting

Intervention / Treatment

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.

This study aims to evaluate the ability of ChatGPT to detect surgical site infections (SSI) at the three anatomical levels described by the CDC.

The study will retrospectively compare the results of the AI chatbot in diagnosing SSI, trained using the US CDC definition criteria, with a large cohort of elective colorectal surgery patients already evaluated through a nationwide nosocomial infection surveillance system, which will be the comparative gold standard.

Study Type

Observational

Enrollment (Estimated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Barcelona
      • Granollers, Barcelona, Spain, 08402
        • Recruiting
        • Hospital General de Granollers
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective colorectal surgery in Hospital General de Granollers in the period 2010-2023

Description

Inclusion Criteria:

  • Elective colorectal resection

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 by manual system in colorectal surgery procedures enrolled in the SSI surveillance programme.
Patients assessed for SSI by Open IA's ChatGPT 4 chatbot
Patients undergoing colorectal surgery enrolled in the nationwide SSI surveillance programme and assessed for SSI using the Open IA's ChatGPT 4 chatbot.
Diagnosis of SSI by manual system in colorectal surgery procedures enrolled in the SSI surveillance programme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of surgical site infection
Time Frame: 30 days
Rate of Surgical site infection according to the definitions of the CDC-NHSN (Centers for Disease Control and Prevention-National Healthcare Safety Network)
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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