Surgeon's Performance in Predicting Postoperative Infections

NCT ID: NCT05961930

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 594 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-09-10

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.

Conditions

Postoperative Infection

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Questionnaire

Intervention Type: BEHAVIORAL

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

Interventions

Questionnaire

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

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sesmu M. Arbous, MD PhD MSc

Principal Investigator, Sesmu M. Arbous, MD PhD MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sesmu Arbous

Leiden, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

2022-64

Identifier Type: -

Identifier Source: org_study_id