An observational study in Laparoscopic Abdominal Surgery, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-24.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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 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.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients meeting eligibility criteria and scheduled for elective minimally-invasive surgery in the general surgery departments of participating centers.
Exclusion Criteria:
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)
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
Severity
Prevalence per severity of iAE
Time frame: Day of the surgical procedure (1 day)
Video-Based Assessment
Correlation between iAE and surgical performance assessed through validated VBA tools
Time frame: Day of the surgical procedure (1 day)
Root causes
Qualitative analysis of root cause analysis and mitigation strategies
Time frame: Day of the surgical procedure (1 day)
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS