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OpenTrials
Completed

NCT Number: NCT05961930

Surgeon's Performance in Predicting Postoperative Infections

Post-surgical (bacterial) infections are the most frequent post-surgical complications, including deep or superficial wound infections, urinary tract infections, pneumonia, and even sepsis. Approximately 6.5-25% of all surgical patients will develop any type of bacterial infection. To personalize surgical infection management, (Artificial Intelligence) models are in the making to predict which patients are at high or low risk of developing a post-surgical infection. In order to benchmark these prediction models to the predictive capabilities of surgeons, the investigators aim to investigate the performance of surgeons in predicting the risk of a patient developing (any type) of post-surgical infection within 30 days.

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Key information

Conditions

Postoperative Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sesmu Arbous

Leiden, South Holland, 2333 ZA, Netherlands

About this study

A prospective non-interventional study is performed to collect surgeons' predictions on the risk of a patient developing a postoperative infection within 30 days of surgery. Surgeons are asked to fill in a short questionnaire asking about the estimated infection risk. The actual outcome (infection < 30 days of surgery) of a patient will be collected retrospectively after completion of the study. This study will have no effect on standard care: surgical interventions and postoperative care will be carried out according to standard clinical practice. Besides a one-time estimate of the surgeon, immediately after the surgical procedure, no other interventions will be performed and surgical specialists will carry out their normal post-surgical care, including screening and treating (if necessary) their patients for postoperative infections.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Predictions are made for patients with the following inclusion and exclusion criteria:

Inclusion criteria

  • Adult patients (>18 years old)
  • Acute or elective surgery
  • Invasive or minimally invasive surgical procedures

Exclusion criteria

  • Outpatient procedures or procedures not requiring any form of monitoring/anesthesia
  • Procedures for which the primary indication is (treatment for) an infection
  • Radiological procedures
  • Cardiological catheterization procedures
  • Psychiatric treatment under anaesthesia (i.e. electroconvulsive therapy)
  • Sole anaesthetic procedures except for implantation of a neurostimulator
  • Brachytherapy procedures
  • Endoscopic procedures for diagnostic purposes only
  • Procedures that only entail the taking of a biopsy for diagnostic purposes
  • Patients that are pregnant
  • Procedures out of office hours (before 8.00 am or after 5.00 pm)

Treatment and study plan

Questionnaire

Behavioral

Surgeons will be asked to fill in a short questionnaire after surgery on risk of postoperative infection

Primary outcomes

  1. The discriminative predictive performance of surgeons with respect to estimating the risk of developing (any type) bacterial post-surgical within 30 days of surgery

    Time frame: 30 days

    The primary outcome measure of discrimination are area under the receiving operating characteristic curve (AUROC). Predictions are compared to the occurrence of a postoperative infection requiring treatment, surgical intervention or registration within 30 days of surgery.

  2. The calibration properties of surgeons with respect to estimating the risk of developing (any type) bacterial post-surgical within 30 days of surgery

    Time frame: 30 days

    Calibration plots with slope and intercept

Secondary outcomes

  1. Relationship between the certainty in estimate and the predictive performance of surgeons

    Time frame: 30 days

    Surgeons are questioned on their certainty in the provided estimate

  2. Relationship between patient factors and predicted risk

    Time frame: 30 days

    Surgeons are questioned to indicate for a list of patient factors whether they were of impact to the decision

  3. Predictive performance per surgeons and patients subgroups

    Time frame: 30 days

    Surgeons subgroups are based on specialty, years of experience, level of experience, sex. Patient subgroups include, surgical specialty, age groups, type of surgical procedure, planned or emergency intervention.

  4. Relationship between predicted risk of surgeons and if they perform additional actions

    Time frame: 30 days

    Surgeons are asked to indicate whether they performed additional actions for this patient in the questionnaire.

  5. Comparison between the predicted risk of surgeons and an artificial intelligence algorithm

    Time frame: 30 days

    The performance of the physicians is compared to that of the artificial intelligence algorithm by means of AUROC

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Acronym: SPIRIT

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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