Laparoscopic Abdominal SurgeryOPERATENCT06655948
Outcome-related Performance Evaluation Through Revision and Analysis of inTraoperative Events
An observational study of Laparoscopic Abdominal Surgery, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Abdominal Surgery
- How many people
- 700 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Oct 2024to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients meeting eligibility criteria and scheduled for elective minimally-invasive surgery in the general surgery departments of participating centers.
Who may be able to join
- Patients scheduled for elective minimally-invasive surgery in participating centers
- Patients with no contraindication to anesthesia and laparoscopic procedures
- Capable of providing informed consent
Who cannot join
- Surgery performed with palliative intent or under unplanned/emergency setting
- Pregnant or breastfeeding patient
- Patient under legal custody or guardianship
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Pietro Mascagni contact
5 sites in 2 countries
Italy4 sites
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, 20122
Luigi Boni, Professor, +390250320326, luigi.boni@unimi.it
Ospedale Isola TIberina - Gemelli Isola
Rome, RM, 00186
Vincenzo Tondolo, MD, +39066837646, vincenzo.tondolo@fbf-isola.it
Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, RM, 00189
Gianfranco Silecchia, Professor, +390633775607, gianfranco.silecchia@uniroma1.it
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, RO, 00168
Sergio Alfieri, Professor, +390630154477, sergio.alfieri@policlinicogemelli.it
France1 site
IHU Strasbourg
Strasbourg, 67000
Nicolas Padoy, Professor, +330390413600, nicolas.padoy@ihu-strasbourg.eu
About this study
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
Read the 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.
- Conditions
- Laparoscopic Abdominal Surgery
- Keywords
- Intraoperative Adverse Events, Video-Based Assessment, Minimally Invasive Surgery, Surgical Performance, Patient Outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of intraoperative adverse events
The prevalence of iAEs will be assessed using validated VBA tools including the Objective Clinical Human Reliability Analysis (OCHRA), the European Association for Endoscopic Surgery (EAES) classification, and the Severity of Intraoperative Events and Rectification (SEVERE) index.
Measured: Day of the surgical procedure (1 day)
Secondary outcomes (4)
Outcomes correlation
Correlation between iAE and clinical outcomes, overall and per iAEs severity
Measured: From the day of the surgical procedure up to 5 years of follow up
Severity
Prevalence per severity of iAE
Measured: Day of the surgical procedure (1 day)
Video-Based Assessment
Correlation between iAE and surgical performance assessed through validated VBA tools
Measured: Day of the surgical procedure (1 day)
Root causes
Qualitative analysis of root cause analysis and mitigation strategies
Measured: Day of the surgical procedure (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergio Alfieri, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655948
- Sponsor's protocol ID
- 6456
- Acronym
- OPERATE
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome-related Performance Evaluation Through Revision and Analysis of inTraoperative Events
- ClinicalTrials.gov ID
- NCT06655948
- Acronym / sponsor ID
- OPERATE / 6456
- Conditions
- Laparoscopic Abdominal Surgery
- Keywords
- Intraoperative Adverse Events, Video-Based Assessment, Minimally Invasive Surgery, Surgical Performance, Patient Outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients meeting eligibility criteria and scheduled for elective minimally-invasive surgery in the general surgery departments of participating centers.
Key inclusion criteria (3 listed)
- Patients scheduled for elective minimally-invasive surgery in participating centers
- Patients with no contraindication to anesthesia and laparoscopic procedures
- Capable of providing informed consent
Key exclusion criteria (3 listed)
- Surgery performed with palliative intent or under unplanned/emergency setting
- Pregnant or breastfeeding patient
- Patient under legal custody or guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of intraoperative adverse events
Time frame: Day of the surgical procedure (1 day)
The prevalence of iAEs will be assessed using validated VBA tools including the Objective Clinical Human Reliability Analysis (OCHRA), the European Association for Endoscopic Surgery (EAES) classification, and the Severity of Intraoperative Events and Rectification (SEVERE) index.
4 secondary outcomes
Outcomes correlation
Time frame: From the day of the surgical procedure up to 5 years of follow up
Severity
Time frame: Day of the surgical procedure (1 day)
Video-Based Assessment
Time frame: Day of the surgical procedure (1 day)
Root causes
Time frame: Day of the surgical procedure (1 day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pietro Mascagni contact
Sergio Alfieri principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Abdominal Surgery, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergio Alfieri, prof (+390630154477, sergio.alfieri@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of intraoperative adverse events (time frame: Day of the surgical procedure (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.