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ClinicalTrials.gov ID

NCT06655948

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

700Estimated

Last Update Posted

Oct 24, 2024Actual

Start Date

Oct 2024Estimated

Primary Completion Date

Oct 2027Estimated

Completion Date

Oct 2029Estimated

Official Title

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

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

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.

• Laparoscopic Abdominal Surgery

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

vincenzo.tondolo@fbf-isola.it+39066837646