Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05778019
Status:
RECRUITING
Last Update Posted:
2023-03-21
First Post:
2023-02-27
Brief Title:
Validating the Novel Classification for the Assessment and Grading of Unexpected Events in Pediatric Surgery The Clavien-Madadi Classification
Sponsor:
Hannover Medical School
Organization:
Hannover Medical School
Study Overview
Official Title:
Validation of Clavien-Madadi Classification for the Grading of Unexpected Events in Pediatric Surgery
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ComPedS
Brief Summary:
Despite appraisal of the Clavien-Dindo classification in the pediatric surgical literature some criticize the transfer of the grading systems for adults in a pediatric cohort without modifications In a recent study it has been shown that few items of the classification do not offer additional information in pediatric cohorts and organizational and management errors have been integrated not being part of the initial proposal by Dindo et al
In a group of pediatric and general surgeons methodologists and statisticians of the ERNICA network the Clavien-Dindo classification has been modified for the application in pediatric surgery The aim is to test and validate the novel Clavien-Madadi classification in a pediatric surgical cohort
In a group of pediatric and general surgeons methodologists and statisticians of the ERNICA network the Clavien-Dindo classification has been modified for the application in pediatric surgery The aim is to test and validate the novel Clavien-Madadi classification in a pediatric surgical cohort
Detailed Description:
Based on the protocol by Dindo et al for the assessment of the international acceptability and reproducibility of the Clavien-Dindo classification the aim is to circulate case scenarios of complications unexpected events within the ERNICA European Reference Network for Rare Inherited Congenital Anomalies network Those case scenarios 15-20 should be graded by the respondents according to the Clavien-Dindo and Clavien-Madadi classification and preferences for future practice should be reported
Milestones
1 All members of the working group send the PIs 1-2 case scenarios with unexpected events in the management and treatment of neonates preferably congenital diseases and children for each grade of the Clavien-Madadi classification
2 All case scenarios will be circulated within the working group and will be ranked with a Likert scale 1 not accurate - 5 accurate regarding the plausibility for an international survey
3 A final proposal of 15-20 case scenarios will be circulated within the working group
4 Circulating the case scenarios and the additional questionnaire via the ERNICA email distribution system and newsletter
Milestones
1 All members of the working group send the PIs 1-2 case scenarios with unexpected events in the management and treatment of neonates preferably congenital diseases and children for each grade of the Clavien-Madadi classification
2 All case scenarios will be circulated within the working group and will be ranked with a Likert scale 1 not accurate - 5 accurate regarding the plausibility for an international survey
3 A final proposal of 15-20 case scenarios will be circulated within the working group
4 Circulating the case scenarios and the additional questionnaire via the ERNICA email distribution system and newsletter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None