Intraoperative ComplicationsICARUS-CNCT05270603
The Intraoperative Complication Assessment and Reporting With Universal Standards - Calculator (ICARUS-C)
An observational study of Intraoperative Complications and Surgery--Complications, run by University of Southern California at 1 site in United States.
Trial summary
As part of the initiative known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) project, the investigators are working to develop a set of tools to aid in improving the homogenous reporting of intraoperative adverse events (iAEs). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Complications, Surgery--Complications, Surgery
- What is being tested?
- ICARUS intraoperative adverse events calculator
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study team will identify corresponding authors who have published articles at any point during 2019-2021 in key American and European scientific surgical journals. The study team plans to email up to 1500 authors from each of these journals - though, many of these journals will not likely have substantially fewer corresponding authors. Specifically, these journals will be associated with one or more of the following specialties: Anesthesiology Interventional Radiology Interventional Cardiology Cardiothoracic Surgery Colon and rectal surgery General Surgery Gynecologic oncology Gynecology and obstetrics Neurological Surgery Ophthalmologic Surgery Oral and maxillofacial Surgery Orthopaedic Surgery Otorhinolaryngology Plastic Surgery Urology Vascular Surgery
Who may be able to join
- Documented understanding, willingness, and agreement to participate in this study
- Males and females; age 18 or older
- Must be either English speaking or fluent with English medical terminology
- Currently or formerly practicing surgeon or proceduralist, regardless of the domain
Who cannot join
- Activity restrictions that limit one's ability to engage in online survey
- Adults not competent to consent
- Minors, human fetuses, neonates Prisoners/Detainees
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90005
About this study
Official title: Comparing the Reliability of a Web-based Intraoperative Adverse Event Assessment Tool With Standard Cognitive Grading. The Intraoperative Complication Assessment and Reporting With Universal Standards - Calculator (ICARUS-C)
As part of the initiative known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) project, the investigators are working to develop a set of tools to aid in improving the homogenous reporting of intraoperative adverse events (iAEs). Accordingly, the investigators developed a web-based tool, known as the ICARUS Calculator, that integrates the 5 published iAE grading systems. We plan to compare the consistency of grading responses between the ICARUS Calculator and the individual grading systems as presented in their respective publications.
The purpose of this study is two-fold. First, the investigators hope to evaluate the utility of a web-based intraoperative adverse event (iAE) grading system known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) calculator. Second, the investigators plan to evaluate the difference in iAE grading outcomes of the ICARUS calculator compared with standard iAE grading.
Read the detailed description
Perioperative complications, especially intraoperative adverse events (iAEs), carry significant potential for long-term sequelae in a patient's postoperative course. Without consistent and homogenous reporting, these events represent a substantial gap in contemporary surgical literature and clinical practice. By definition, an iAE is any unplanned incident related to a surgical intervention occurring between skin incision and skin closure. Despite the availability of multiple intraoperative grading and classification systems, colloquiallary known as: EAUiaiC, iAE severity classification scheme, Modified Satava, EAES Grading system, and ClassIntra® (formerly CLASSIC) , the reporting of intraoperative adverse events remains exceedingly rare. Further, while most studies report postoperative adverse events, only a fraction of surgical publications report intraoperative complications as outcomes of interest.
As part of the initiative known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) project, the investigators are working to develop a set of tools to aid in improving the homogenous reporting of iAEs. Accordingly, the investigators developed a web-based tool, known as the ICARUS Calculator, that integrates the four aforementioned iAE grading systems. The investigators plan to compare the consistency of grading responses between the ICARUS Calculator and the individual grading systems as presented in their respective publications.
- Conditions
- Intraoperative Complications, Surgery--Complications, Surgery, Surgical Procedure, Unspecified
- Being tested
- ICARUS intraoperative adverse events calculator
- Keywords
- ICARUS, Intraoperative Complications, ICARUS Calculator
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICARUS intraoperative adverse events calculatorOther
The ICARUS calculator is a web-based tool that uses answers to Boolean, yes/no questions to determine the iAE grade (appendix I). The calculator providers iAE grade outputs for the 5 iAE classification systems.
https://garnmile.com/iaecalc/
Development of the ICARUS calculator was performed as follows: Referencing the 5 classification systems, we first assembled a list of Boolean questions based on the iAE grade descriptions. This list was distilled to the minimum number of questions necessary to represent all descriptions in the combined list of iAE grades. Next, these questions were used to independently establish the conditional logic required to determine iAE grade for each classification system. The questions and logic were translated into Hypertext Preprocessor (PHP), a server-side programming language, and JavaScript, a client-side scripting language.
| Study group | Role | What they receive |
|---|---|---|
| ICARUS Calculator Raters (Intervention Group) | Surgeons and anesthesiologists will be asked to use the ICARUS Calculator to grade a subset of 10 clinical scenarios selected from a list of the clinical scenarios and examples from the publications of the 5iAE systems Receives: Other: ICARUS intraoperative adverse events calculator | |
| Cognitive Grading Raters (Control Group) | Surgeons and anesthesiologists will be asked to use the ICARUS Calculator to grade a subset of 10 clinical scenarios (same as the Intervention group) selected from a list of the clinical scenarios and examples from the publications of the 5iAE systems Receives: Other: ICARUS intraoperative adverse events calculator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Distribution of responses by count and percent
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows:
-Distribution of responses by count and percent
Measured: 03-01-2022 to 03-15-2022
Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Percent agreement of grade
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows:
-Percent agreement of grade
Measured: 03-01-2022 to 03-15-2022
Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems using the Cohen's Kappa
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows:
- Cohen's Kappa
Measured: 03-01-2022 to 03-15-2022
Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems using the Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows:
-Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades
Measured: 03-01-2022 to 03-15-2022
Evaluate theTime to complete grading (minutes) using the 5 iAEs grading systems
Primary data analysis will involve calculations i to evaluate the consistency and inter-rater agreement for each grading system, as follows:
-Time to complete grading (minutes)
Measured: 03-01-2022 to 03-15-2022
Evaluate the consistency and inter-rater reliability of the ICARUS Calculator in term of Distribution of responses by count and percent
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows:
-Distribution of responses by count and percent
Measured: 03-16-2022- to 06-01-2022
Evaluate the consistency and inter-rater reliability of the ICARUS Calculator in terms of Percent agreement of grade
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows:
-Percent agreement of grade
Measured: 03-16-2022- to 06-01-2022
Evaluate the consistency and inter-rater reliability of the ICARUS Calculator using Cohen's Kappa
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows:
- Cohen's Kappa
Measured: 03-16-2022- to 06-01-2022
Evaluate the consistency and inter-rater reliability of the ICARUS Calculator using Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows:
-Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades
Measured: 03-16-2022- to 06-01-2022
Evaluate Time to complete grading (minutes)using the ICARUS Calculator
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows:
-Time to complete grading (minutes)
Measured: 03-16-2022- to 06-01-2022
Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
There will be 5 output groupings involving the grading systems:
- ICARUS calculator vs. EAUiaiC
- ICARUS calculator vs. iAE severity
- ICARUS calculator vs. Modified Satava
- ICARUS calculator vs. ClassIntra
- ICARUS calculator vs. EAES Classification
Measured: 03-16-2022- to 06-01-2022
Determination of benefit in efficiency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
There will be 5 output groupings involving the grading systems:
- ICARUS calculator vs. EAUiaiC
- ICARUS calculator vs. iAE severity
- ICARUS calculator vs. Modified Satava
- ICARUS calculator vs. ClassIntra
- ICARUS calculator vs. EAES Classification
Measured: 03-16-2022- to 06-01-2022
Determination of benefit in consistency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
There will be 5 output groupings involving the grading systems:
- ICARUS calculator vs. EAUiaiC
- ICARUS calculator vs. iAE severity
- ICARUS calculator vs. Modified Satava
- ICARUS calculator vs. ClassIntra
- ICARUS calculator vs. EAES Classification
Measured: 03-16-2022- to 06-01-2022
Determination of benefit in inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
There will be 5 output groupings involving the grading systems:
- ICARUS calculator vs. EAUiaiC
- ICARUS calculator vs. iAE severity
- ICARUS calculator vs. Modified Satava
- ICARUS calculator vs. ClassIntra
- ICARUS calculator vs. EAES Classification
Measured: 03-16-2022- to 06-01-2022
Secondary outcomes (3)
Evaluation of the experience using the ICARUS calculator by System Usability Scale (SUS) questionnaire
Assess the physician satisfaction using a validated questionnaires System Usability Scale (SUS) questionnaire
Measured: 03-16-2022- to 06-01-2022
Evaluation of the experience using the ICARUS calculator by using the Usefulness, Satisfaction and Ease of Use (USE) questionnaire.
Assess the physician satisfaction using a validated questionnaires: Questionnaire for User Interaction Satisfaction (QUIS) and Usefulness, Satisfaction and Ease of Use (USE) questionnaire
Measured: 03-16-2022- to 06-01-2022
Evaluation of the experience using the ICARUS calculator by using Questionnaire for User Interaction Satisfaction (QUIS)
Assess the physician satisfaction using a validated questionnaires: Questionnaire for User Interaction Satisfaction (QUIS)
Measured: 03-16-2022- to 06-01-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start15 Mar 2022
- Primary completion15 Apr 2022
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intraoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Cacciamani, University of Southern California
- Investigators
- Giovanni Cacciamani, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270603
- Sponsor's protocol ID
- UP-21-01010
- Acronym
- ICARUS-C
- Status last verified
- May 2022
- First submitted
- 15 Feb 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Biyani CS, Pecanka J, Roupret M, Jensen JB, Mitropoulos D. Intraoperative Adverse Incident Classification (EAUiaiC) by the European Association of Urology ad hoc Complications Guidelines Panel. Eur Urol. 2020 May;77(5):601-610. doi: 10.1016/j.eururo.2019.11.015. Epub 2019 Nov 29.
PubMed 31787430Kaafarani HM, Mavros MN, Hwabejire J, Fagenholz P, Yeh DD, Demoya M, King DR, Alam HB, Chang Y, Hutter M, Antonelli D, Gervasini A, Velmahos GC. Derivation and validation of a novel severity classification for intraoperative adverse events. J Am Coll Surg. 2014 Jun;218(6):1120-8. doi: 10.1016/j.jamcollsurg.2013.12.060. Epub 2014 Feb 28.
PubMed 24702887Kazaryan AM, Rosok BI, Edwin B. Morbidity assessment in surgery: refinement proposal based on a concept of perioperative adverse events. ISRN Surg. 2013 May 16;2013:625093. doi: 10.1155/2013/625093. Print 2013.
PubMed 23762627Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917.
PubMed 32843333Francis NK, Curtis NJ, Conti JA, Foster JD, Bonjer HJ, Hanna GB; EAES committees. EAES classification of intraoperative adverse events in laparoscopic surgery. Surg Endosc. 2018 Sep;32(9):3822-3829. doi: 10.1007/s00464-018-6108-1. Epub 2018 Feb 12.
PubMed 29435754Cacciamani G, Sholklapper T, Sotelo R, Desai M, Gill I. A Protocol for the Development of the Intraoperative Complications Assessment and Reporting With Universal Standards Criteria: The ICARUS Project. Int J Surg Protoc. 2021 Aug 6;25(1):160-164. doi: 10.29337/ijsp.155. eCollection 2021.
PubMed 34430764
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Reliability of a Web-based Intraoperative Adverse Event Assessment Tool With Standard Cognitive Grading. The Intraoperative Complication Assessment and Reporting With Universal Standards - Calculator (ICARUS-C)
- ClinicalTrials.gov ID
- NCT05270603
- Acronym / sponsor ID
- ICARUS-C / UP-21-01010
- Conditions
- Intraoperative Complications, Surgery--Complications, Surgery, Surgical Procedure, Unspecified
- Keywords
- ICARUS, Intraoperative Complications, ICARUS Calculator
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 8 Mar 2022 (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.
As part of the initiative known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) project, the investigators are working to develop a set of tools to aid in improving the homogenous reporting of intraoperative adverse events (iAEs). Accordingly, the investigators developed a web-based tool, known as the ICARUS Calculator, that integrates the 5 published iAE grading systems. We plan to compare the consistency of grading responses between the ICARUS Calculator and the individual grading systems as presented in their respective publications.
The purpose of this study is two-fold. First, the investigators hope to evaluate the utility of a web-based intraoperative adverse event (iAE) grading system known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) calculator. Second, the investigators plan to evaluate the difference in iAE grading outcomes of the ICARUS calculator compared with standard iAE grading.
Detailed description
Perioperative complications, especially intraoperative adverse events (iAEs), carry significant potential for long-term sequelae in a patient's postoperative course. Without consistent and homogenous reporting, these events represent a substantial gap in contemporary surgical literature and clinical practice. By definition, an iAE is any unplanned incident related to a surgical intervention occurring between skin incision and skin closure. Despite the availability of multiple intraoperative grading and classification systems, colloquiallary known as: EAUiaiC, iAE severity classification scheme, Modified Satava, EAES Grading system, and ClassIntra® (formerly CLASSIC) , the reporting of intraoperative adverse events remains exceedingly rare. Further, while most studies report postoperative adverse events, only a fraction of surgical publications report intraoperative complications as outcomes of interest.
As part of the initiative known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) project, the investigators are working to develop a set of tools to aid in improving the homogenous reporting of iAEs. Accordingly, the investigators developed a web-based tool, known as the ICARUS Calculator, that integrates the four aforementioned iAE grading systems. The investigators plan to compare the consistency of grading responses between the ICARUS Calculator and the individual grading systems as presented in their respective publications.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICARUS Calculator Raters (Intervention Group) | – | Other: ICARUS intraoperative adverse events calculatorSurgeons and anesthesiologists will be asked to use the ICARUS Calculator to grade a subset of 10 clinical scenarios selected from a list of the clinical scenarios and examples from the publications of the 5iAE systems |
| Cognitive Grading Raters (Control Group) | – | Other: ICARUS intraoperative adverse events calculatorSurgeons and anesthesiologists will be asked to use the ICARUS Calculator to grade a subset of 10 clinical scenarios (same as the Intervention group) selected from a list of the clinical scenarios and examples from the publications of the 5iAE systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study team will identify corresponding authors who have published articles at any point during 2019-2021 in key American and European scientific surgical journals. The study team plans to email up to 1500 authors from each of these journals - though, many of these journals will not likely have substantially fewer corresponding authors. Specifically, these journals will be associated with one or more of the following specialties: Anesthesiology Interventional Radiology Interventional Cardiology Cardiothoracic Surgery Colon and rectal surgery General Surgery Gynecologic oncology Gynecology and obstetrics Neurological Surgery Ophthalmologic Surgery Oral and maxillofacial Surgery Orthopaedic Surgery Otorhinolaryngology Plastic Surgery Urology Vascular Surgery
Key inclusion criteria (4 listed)
- Documented understanding, willingness, and agreement to participate in this study
- Males and females; age 18 or older
- Must be either English speaking or fluent with English medical terminology
- Currently or formerly practicing surgeon or proceduralist, regardless of the domain
Key exclusion criteria (3 listed)
- Activity restrictions that limit one's ability to engage in online survey
- Adults not competent to consent
- Minors, human fetuses, neonates Prisoners/Detainees
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICARUS intraoperative adverse events calculatorThe ICARUS calculator is a web-based tool that uses answers to Boolean, yes/no questions to determine the iAE grade (appendix I). The calculator providers iAE grade outputs for the 5 iAE classification systems. https://garnmile.com/iaecalc/ Development of the ICARUS calculator was performed as follows: Referencing the 5 classification systems, we first assembled a list of Boolean questions based on the iAE grade descriptions. This list was distilled to the minimum number of questions necessary to represent all descriptions in the combined list of iAE grades. Next, these questions were used to independently establish the conditional logic required to determine iAE grade for each classification system. The questions and logic were translated into Hypertext Preprocessor (PHP), a server-side programming language, and JavaScript, a client-side scripting language. | Other | Cognitive Grading Raters (Control Group), ICARUS Calculator Raters (Intervention Group) |
Primary outcome
Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Distribution of responses by count and percent
Time frame: 03-01-2022 to 03-15-2022
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Distribution of responses by count and percent
Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Percent agreement of grade
Time frame: 03-01-2022 to 03-15-2022
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Percent agreement of grade
Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems using the Cohen's Kappa
Time frame: 03-01-2022 to 03-15-2022
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: - Cohen's Kappa
Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems using the Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades
Time frame: 03-01-2022 to 03-15-2022
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades
Evaluate theTime to complete grading (minutes) using the 5 iAEs grading systems
Time frame: 03-01-2022 to 03-15-2022
Primary data analysis will involve calculations i to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Time to complete grading (minutes)
Evaluate the consistency and inter-rater reliability of the ICARUS Calculator in term of Distribution of responses by count and percent
Time frame: 03-16-2022- to 06-01-2022
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Distribution of responses by count and percent
Evaluate the consistency and inter-rater reliability of the ICARUS Calculator in terms of Percent agreement of grade
Time frame: 03-16-2022- to 06-01-2022
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Percent agreement of grade
Evaluate the consistency and inter-rater reliability of the ICARUS Calculator using Cohen's Kappa
Time frame: 03-16-2022- to 06-01-2022
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: - Cohen's Kappa
Evaluate the consistency and inter-rater reliability of the ICARUS Calculator using Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades
Time frame: 03-16-2022- to 06-01-2022
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades
Evaluate Time to complete grading (minutes)using the ICARUS Calculator
Time frame: 03-16-2022- to 06-01-2022
Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Time to complete grading (minutes)
Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
Time frame: 03-16-2022- to 06-01-2022
Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events There will be 5 output groupings involving the grading systems: 1. ICARUS calculator vs. EAUiaiC 2. ICARUS calculator vs. iAE severity 3. ICARUS calculator vs. Modified Satava 4. ICARUS calculator vs. ClassIntra 5. ICARUS calculator vs. EAES Classification
Determination of benefit in efficiency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
Time frame: 03-16-2022- to 06-01-2022
Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events There will be 5 output groupings involving the grading systems: 1. ICARUS calculator vs. EAUiaiC 2. ICARUS calculator vs. iAE severity 3. ICARUS calculator vs. Modified Satava 4. ICARUS calculator vs. ClassIntra 5. ICARUS calculator vs. EAES Classification
Determination of benefit in consistency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
Time frame: 03-16-2022- to 06-01-2022
Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events There will be 5 output groupings involving the grading systems: 1. ICARUS calculator vs. EAUiaiC 2. ICARUS calculator vs. iAE severity 3. ICARUS calculator vs. Modified Satava 4. ICARUS calculator vs. ClassIntra 5. ICARUS calculator vs. EAES Classification
Determination of benefit in inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
Time frame: 03-16-2022- to 06-01-2022
Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events There will be 5 output groupings involving the grading systems: 1. ICARUS calculator vs. EAUiaiC 2. ICARUS calculator vs. iAE severity 3. ICARUS calculator vs. Modified Satava 4. ICARUS calculator vs. ClassIntra 5. ICARUS calculator vs. EAES Classification
3 secondary outcomes
Evaluation of the experience using the ICARUS calculator by System Usability Scale (SUS) questionnaire
Time frame: 03-16-2022- to 06-01-2022
Evaluation of the experience using the ICARUS calculator by using the Usefulness, Satisfaction and Ease of Use (USE) questionnaire.
Time frame: 03-16-2022- to 06-01-2022
Evaluation of the experience using the ICARUS calculator by using Questionnaire for User Interaction Satisfaction (QUIS)
Time frame: 03-16-2022- to 06-01-2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Background: PubMed 31787430Biyani CS, Pecanka J, Roupret M, Jensen JB, Mitropoulos D. Intraoperative Adverse Incident Classification (EAUiaiC) by the European Association of Urology ad hoc Complications Guidelines Panel. Eur Urol. 2020 May;77(5):601-610. doi: 10.1016/j.eururo.2019.11.015. Epub 2019 Nov 29.
- Background: PubMed 24702887Kaafarani HM, Mavros MN, Hwabejire J, Fagenholz P, Yeh DD, Demoya M, King DR, Alam HB, Chang Y, Hutter M, Antonelli D, Gervasini A, Velmahos GC. Derivation and validation of a novel severity classification for intraoperative adverse events. J Am Coll Surg. 2014 Jun;218(6):1120-8. doi: 10.1016/j.jamcollsurg.2013.12.060. Epub 2014 Feb 28.
- Background: PubMed 23762627Kazaryan AM, Rosok BI, Edwin B. Morbidity assessment in surgery: refinement proposal based on a concept of perioperative adverse events. ISRN Surg. 2013 May 16;2013:625093. doi: 10.1155/2013/625093. Print 2013.
- Background: PubMed 32843333Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917.
- Background: PubMed 29435754Francis NK, Curtis NJ, Conti JA, Foster JD, Bonjer HJ, Hanna GB; EAES committees. EAES classification of intraoperative adverse events in laparoscopic surgery. Surg Endosc. 2018 Sep;32(9):3822-3829. doi: 10.1007/s00464-018-6108-1. Epub 2018 Feb 12.
- Background: PubMed 34430764Cacciamani G, Sholklapper T, Sotelo R, Desai M, Gill I. A Protocol for the Development of the Intraoperative Complications Assessment and Reporting With Universal Standards Criteria: The ICARUS Project. Int J Surg Protoc. 2021 Aug 6;25(1):160-164. doi: 10.29337/ijsp.155. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Giovanni Cacciamani, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Complications and Surgery--Complications, run by University of Southern California at 1 site in United States.
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 4 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: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Distribution of responses by count and percent (time frame: 03-01-2022 to 03-15-2022). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05270603, which also lists 6 linked publications.
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 5 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.