Surgeon's Performance in Predicting Postoperative Infections

Postoperative Infection Clinical Trial

— SPIRIT  

Official title:

Surgeon's Performance in Predicting Postoperative Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961930
• Other study ID #: 2022-64
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2023
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 588
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Postoperative Infection

Intervention

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

Locations

Country	Name	City	State
Netherlands	Sesmu Arbous	Leiden	Zuid-holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Relationship between the certainty in estimate and the predictive performance of surgeons	Surgeons are questioned on their certainty in the provided estimate	30 days
Secondary	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
Secondary	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
Secondary	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