NCT05277441

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: —

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2022-12-31
• Completion: 2023-01-01
• First posted: 2022-03-14
• Last updated: 2022-03-14

Locations

1 site across 1 country: Germany