Outcome-related Performance Evaluation Through Revision and Analysis of inTraoperative Events
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Laparoscopic Abdominal Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed description
The OPERATE study is a prospective, multicenter observational cohort study focused on evaluating the prevalence and impact of intraoperative adverse events (iAEs) during minimally invasive surgeries. The study aims to systematically collect and analyze surgical videos and clinical outcomes from multiple centers. By using advanced video-based assessment (VBA) tools, such as the Objective Clinical Human Reliability Analysis (OCHRA) and the Severity of Intraoperative Events and Rectification (SEVERE) index, the study will examine how surgical performance correlates with post-operative outcomes.
The study will initially focus on colorectal surgery, with the possibility of expanding to other types of minimally invasive procedures. Videos of the surgeries will be recorded, de-identified, and uploaded to a centralized platform for analysis. The study also seeks to identify root causes of iAEs and develop strategies to prevent them. Data collection will include not only video-based assessments but also patient demographic details, surgical history, and post-operative recovery data.
By understanding the frequency and nature of iAEs, this study aims to improve surgical safety, reduce complications, and ultimately enhance the quality of patient care in a broad range of general surgical procedures. The findings may contribute to developing new training protocols, artificial intelligence instruments to model errors and increase procedural safety, and guidelines to optimize surgical performance and patient outcomes.
Primary outcome measures
- Prevalence of intraoperative adverse events [Time frame: Day of the surgical procedure (1 day)]
Secondary outcome measures (4)
- Outcomes correlation [Time frame: From the day of the surgical procedure up to 5 years of follow up]
- Severity [Time frame: Day of the surgical procedure (1 day)]
- Video-Based Assessment [Time frame: Day of the surgical procedure (1 day)]
- Root causes [Time frame: Day of the surgical procedure (1 day)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 4 centers
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan
- Ospedale Isola TIberina - Gemelli Isola — Rome
- Azienda Ospedaliero-Universitaria Sant'Andrea — Rome
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome
France · 1 center
- IHU Strasbourg — Strasbourg
Identifiers
NCT: NCT06655948 · 6456