Outcome-related Performance Evaluation Through Revision and Analysis of inTraoperative Events

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Day of the surgical procedure (1 day)

Secondary outcomes

1

Outcomes correlation

Correlation between iAE and clinical outcomes, overall and per iAEs severity

Time frame
From the day of the surgical procedure up to 5 years of follow up
2

Severity

Prevalence per severity of iAE

Time frame
Day of the surgical procedure (1 day)
3

Video-Based Assessment

Correlation between iAE and surgical performance assessed through validated VBA tools

Time frame
Day of the surgical procedure (1 day)
4

Root causes

Qualitative analysis of root cause analysis and mitigation strategies

Time frame
Day of the surgical procedure (1 day)

Other outcomes

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: