About this trial
The goal of this prospective, multicentric, observational, cohort study is to evaluate intraoperative adverse events (iAEs) through video-based assessment (VBA) across minimal invasive procedures performed in general surgery departments. The main questions it aims to answer are:
* The prevalence, type, and severity of iAEs * Correlation between iAE and clinical outcomes * Correlation between iAE and surgical performance * Qualitative analysis of root cause analysis and mitigation strategies
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for elective minimally-invasive surgery in participating centers
Patients with no contraindication to anesthesia and laparoscopic procedures
Capable of providing informed consent
Disqualifiers
Surgery performed with palliative intent or under unplanned/emergency setting
Pregnant or breastfeeding patient
Patient under legal custody or guardianship
Trial population
Patients meeting eligibility criteria and scheduled for elective minimally-invasive surgery in the general surgery departments of participating centers.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Prevalence of intraoperative adverse events
The prevalence of iAEs will be assessed using validated VBA tools including the Objective Clinical Human Reliability Analysis (OCHRA), the European Association for Endoscopic Surgery (EAES) classification, and the Severity of Intraoperative Events and Rectification (SEVERE) index.
Secondary outcomes
Outcomes correlation
Correlation between iAE and clinical outcomes, overall and per iAEs severity
Severity
Prevalence per severity of iAE
Video-Based Assessment
Correlation between iAE and surgical performance assessed through validated VBA tools
Root causes
Qualitative analysis of root cause analysis and mitigation strategies
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: