Outcome-related Performance Evaluation Through Revision and Analysis of inTraoperative Events
NCT ID: NCT06655948
Last Updated: 2024-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
700 participants
OBSERVATIONAL
2024-10-31
2029-10-31
Brief Summary
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* 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
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients with no contraindication to anesthesia and laparoscopic procedures
* Capable of providing informed consent
Exclusion Criteria
* Pregnant or breastfeeding patient
* Patient under legal custody or guardianship
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Sergio Alfieri
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
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IHU Strasbourg
Strasbourg, , France
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, Italy
Ospedale Isola TIberina - Gemelli Isola
Rome, RM, Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, RM, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, RO, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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6456
Identifier Type: -
Identifier Source: org_study_id
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