Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655948
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Outcome-related Performance Evaluation Through Revision and Analysis of inTraoperative Events
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Outcome-related Performance Evaluation Through Revision and Analysis of inTraoperative Events
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPERATE
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None