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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Abdominal Surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Sergio Alfieri, prof; Phone Number: +390630154477; Email: sergio.alfieri@policlinicogemelli.it
• Study Contact Backup: Name: Pietro Mascagni; Email: pietro.mascagni@policlinicogemelli.it

Study Locations

• France
  • Strasbourg, France, 67000
    • IHU Strasbourg
    • Contact: Nicolas Padoy, Professor; Phone Number: +330390413600; Email: nicolas.padoy@ihu-strasbourg.eu
• Italy
  • MI
    • Milan, MI, Italy, 20122
      • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Contact: Luigi Boni, Professor; Phone Number: +390250320326; Email: luigi.boni@unimi.it
  • RM
    • Rome, RM, Italy, 00186
      • Ospedale Isola Tiberina - Gemelli Isola
      • Contact: Vincenzo Tondolo, MD; Phone Number: +39066837646; Email: vincenzo.tondolo@fbf-isola.it
    • Rome, RM, Italy, 00189
      • Azienda Ospedaliero-Universitaria Sant'Andrea
      • Contact: Gianfranco Silecchia, Professor; Phone Number: +390633775607; Email: gianfranco.silecchia@uniroma1.it
  • RO
    • Rome, RO, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Contact: Sergio Alfieri, Professor; Phone Number: +390630154477; Email: sergio.alfieri@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients meeting eligibility criteria and scheduled for elective minimally-invasive surgery in the general surgery departments of participating centers.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcomes correlation	Correlation between iAE and clinical outcomes, overall and per iAEs severity	From the day of the surgical procedure up to 5 years of follow up
Severity	Prevalence per severity of iAE	Day of the surgical procedure (1 day)
Video-Based Assessment	Correlation between iAE and surgical performance assessed through validated VBA tools	Day of the surgical procedure (1 day)
Root causes	Qualitative analysis of root cause analysis and mitigation strategies	Day of the surgical procedure (1 day)

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Sergio Alfieri, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Patient Outcomes; Minimally Invasive Surgery; Intraoperative Adverse Events; Video-Based Assessment; Surgical Performance
• Other Study ID Numbers: 6456

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No