Clinical trial NCT05961930: Surgeon's Performance in Predicting Postoperative Infections
Official title: Surgeon's Performance in Predicting Postoperative Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Infection
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 594
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, surgical population of different surgical subspecialties.

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The discriminative predictive performance of surgeons with respect to estimating the risk of developing (any type) bacterial post-surgical within 30 days of surgery
timeFrame: 30 days
measure: The calibration properties of surgeons with respect to estimating the risk of developing (any type) bacterial post-surgical within 30 days of surgery
timeFrame: 30 days
Secondary outcomes:
measure: Relationship between the certainty in estimate and the predictive performance of surgeons
timeFrame: 30 days
measure: Relationship between patient factors and predicted risk
timeFrame: 30 days
measure: Predictive performance per surgeons and patients subgroups
timeFrame: 30 days
measure: Relationship between predicted risk of surgeons and if they perform additional actions
timeFrame: 30 days
measure: Comparison between the predicted risk of surgeons and an artificial intelligence algorithm
timeFrame: 30 days
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Sesmu Arbous
state: Zuid-holland
Study officials:
References: