A Novel Classification for the Assessment and Grading of Unexpected Events in Pediatric Surgery: The Clavien-Madadi Classification

Study Overview
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Brief Summary
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Postoperative adverse events may be associated with substantial morbidity and mortality. However, inconsistent definitions of complications and unexpected events have limited accurate analysis of surgical outcomes. In 2004, the Clavien-Dindo classification for postoperative complications has been introduced and has since then been validated in numerous studies, with more than 20.000 citations. Despite the appraisal of the Clavien-Dindo classification in the pediatric surgical literature, some criticize the transfer of grading systems for adults into a pediatric cohort without modification or validation. In a recent study we have shown that few items of the classification do not offer relevant information in pediatric cohorts and we have added organizational and management errors, not integrated in the initial proposal by Dindo et al. Especially, the variety of options for the management of complications based on institutional protocols and logistics is emphasized and a more focused and detailed assessment of the invasiveness of procedures in children is introduced.

Official Title
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A Novel Classification for the Assessment and Grading of Unexpected Events in Pediatric Surgery: The Clavien-Madadi Classification

Conditions
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Complication of Surgical Procedure, Complication of Anesthesia, Complication,Postoperative, Complication of Medical Care

Intervention / Treatment
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* Diagnostic Test: Novel severity grading system of unexpected events in pediatric surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with unexpected events within the study period, treated at the department of pediatric surgery (preterms - 17 years of age), Hannover Medical School Exclusion Criteria: None;

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Novel severity grading system of unexpected events in pediatric surgery|Classification of unexpected events according to the Clavien-Madadi classification for pediatric surgical patients and simultaneously the non-modified Clavien-Dindo classification in more than 10.000 patients who have been treated at a single center from 2017 to 2022.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorization of adverse events | Events associated with surgical/non-surgical interventions and events not associated with interventions such as organizational problems, management problems or underlying disease were differentiated. | Through study completion, an average of 3 years | 
| Classification of adverse events | According to the Clavien-Dindo classification | Through study completion, an average of 3 years | 
| Classification of adverse events using a novel instrument | According to the Clavien-Madadi classification | Through study completion, an average of 3 years |