Clinical trial NCT06655948: Outcome-related Performance Evaluation Through Revision and Analysis of inTraoperative Events
Official title: Outcome-related Performance Evaluation Through Revision and Analysis of inTraoperative Events
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Laparoscopic Abdominal Surgery
Keywords: Intraoperative Adverse Events
Video-Based Assessment
Minimally Invasive Surgery
Surgical Performance
Patient Outcomes
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Prevalence of intraoperative adverse events
timeFrame: Day of the surgical procedure (1 day)
Secondary outcomes:
measure: Outcomes correlation
timeFrame: From the day of the surgical procedure up to 5 years of follow up
measure: Severity
timeFrame: Day of the surgical procedure (1 day)
measure: Video-Based Assessment
timeFrame: Day of the surgical procedure (1 day)
measure: Root causes
timeFrame: Day of the surgical procedure (1 day)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: IHU Strasbourg
city: Milan
country: Italy
facility: Fondazione IRCCS Ca&#39; Granda Ospedale Maggiore Policlinico
state: MI
city: Rome
country: Italy
facility: Ospedale Isola TIberina - Gemelli Isola
state: RM
city: Rome
country: Italy
facility: Azienda Ospedaliero-Universitaria Sant&#39;Andrea
state: RM
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: RO
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Sergio Alfieri
role: PRINCIPAL_INVESTIGATOR
References: