Surgeon's Performance in Predicting Postoperative Infections (SPIRIT)

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Infection
• Intervention / Treatment: Behavioral: Questionnaire

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 594

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-holland
    • Leiden, Zuid-holland, Netherlands, 2333 ZA
      • Sesmu Arbous

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult, surgical population of different surgical subspecialties.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgeons estimate of postoperative infection; All surgeons will be asked to fill in a questionnaire, containing 5 questions, pertaining to the estimated risk of postoperative infection (within 30days). Thus there is a single arm and no comparison.	Behavioral: Questionnaire; Surgeons will be asked to fill in a short questionnaire after surgery on risk of postoperative infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The discriminative predictive performance of surgeons with respect to estimating the risk of developing (any type) bacterial post-surgical within 30 days of surgery	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.	30 days
The calibration properties of surgeons with respect to estimating the risk of developing (any type) bacterial post-surgical within 30 days of surgery	Calibration plots with slope and intercept	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between the certainty in estimate and the predictive performance of surgeons	Surgeons are questioned on their certainty in the provided estimate	30 days
Relationship between patient factors and predicted risk	Surgeons are questioned to indicate for a list of patient factors whether they were of impact to the decision	30 days
Predictive performance per surgeons and patients subgroups	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.	30 days
Relationship between predicted risk of surgeons and if they perform additional actions	Surgeons are asked to indicate whether they performed additional actions for this patient in the questionnaire.	30 days
Comparison between the predicted risk of surgeons and an artificial intelligence algorithm	The performance of the physicians is compared to that of the artificial intelligence algorithm by means of AUROC	30 days

Collaborators and Investigators

• Sponsor: Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): September 10, 2023

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 2022-64

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
• product manufactured in and exported from the U.S.: No