ComPedS: A Novel Classification for the Assessment and Grading of Unexpected Events in Pediatric Surgery: The Clavien-Madadi Classification
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Incidence of adverse events [Through study completion, an average of 3 years]
Secondary Outcome Measures
- Categorization of adverse events [Through study completion, an average of 3 years]
Events associated with surgical/non-surgical interventions and events not associated with interventions such as organizational problems, management problems or underlying disease were differentiated.
- Classification of adverse events [Through study completion, an average of 3 years]
According to the Clavien-Dindo classification
- Classification of adverse events using a novel instrument [Through study completion, an average of 3 years]
According to the Clavien-Madadi classification
Eligibility Criteria
Criteria
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;
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hannover Medical School | Hannover | Lower Saxony | Germany | 30625 |
Sponsors and Collaborators
- Hannover Medical School
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 9557_BO_K_2021