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Clinical Trials in Italy / NCT06655948
Starting soon Observational

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

NCT06655948 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2024-10
Last updated
2024-10-24

Condition(s) studied

Laparoscopic Abdominal Surgery

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients scheduled for elective minimally-invasive surgery in participating centers * Patients with no contraindication to anesthesia and laparoscopic procedures * Capable of providing informed consent Exclusion Criteria: * Surgery performed with palliative intent or under unplanned/emergency setting * Pregnant or breastfeeding patient * Patient under legal custody or guardianship

Primary outcome measure(s)

  • Prevalence of intraoperative adverse events — Day of the surgical procedure (1 day)
    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.

Trial sites (5)

FacilityCityRegionStatus
IHU Strasbourg Strasbourg France
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan MI
Ospedale Isola TIberina - Gemelli Isola Rome RM
Azienda Ospedaliero-Universitaria Sant'Andrea Rome RM
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome RO

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06655948 on ClinicalTrials.gov ↗ ← All trials in Italy