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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Laparoscopic Abdominal Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT06655948

6456

Details and patient eligibility

About

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

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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