Outcome-related Performance Evaluation Through Revision and Analysis of inTraoperative Events
OPERATE
1 other identifier
observational
700
2 countries
5
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedFirst Posted
Study publicly available on registry
October 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2029
October 24, 2024
September 1, 2024
3 years
September 27, 2024
October 22, 2024
Conditions
Keywords
Outcome Measures
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.
Day of the surgical procedure (1 day)
Secondary Outcomes (4)
Outcomes correlation
From the day of the surgical procedure up to 5 years of follow up
Severity
Day of the surgical procedure (1 day)
Video-Based Assessment
Day of the surgical procedure (1 day)
Root causes
Day of the surgical procedure (1 day)
Eligibility Criteria
Patients meeting eligibility criteria and scheduled for elective minimally-invasive surgery in the general surgery departments of participating centers.
You may qualify if:
- Patients scheduled for elective minimally-invasive surgery in participating centers
- Patients with no contraindication to anesthesia and laparoscopic procedures
- Capable of providing informed consent
You may not qualify if:
- Surgery performed with palliative intent or under unplanned/emergency setting
- Pregnant or breastfeeding patient
- Patient under legal custody or guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
IHU Strasbourg
Strasbourg, 67000, France
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, 20122, Italy
Ospedale Isola TIberina - Gemelli Isola
Rome, RM, 00186, Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, RM, 00189, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, RO, 00168, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Sergio Alfieri
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2024
First Posted
October 24, 2024
Study Start
October 1, 2024
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2029
Last Updated
October 24, 2024
Record last verified: 2024-09