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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05277441
Acronym
ComPedS
Enrollment
10000
Registered
2022-03-14
Start date
2017-01-01
Completion date
2023-01-01
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTNovel 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.

Sponsors

Hannover Medical School
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years

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;

Design outcomes

Primary

MeasureTime frame
Incidence of adverse eventsThrough study completion, an average of 3 years

Secondary

MeasureTime frameDescription
Categorization of adverse eventsThrough study completion, an average of 3 yearsEvents 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 eventsThrough study completion, an average of 3 yearsAccording to the Clavien-Dindo classification
Classification of adverse events using a novel instrumentThrough study completion, an average of 3 yearsAccording to the Clavien-Madadi classification

Countries

Germany

Contacts

Primary ContactOmid Madadi-Sanjani, Dr
madadi-sanjani.omid@mh-hannover.de+49-176-15329053
Backup ContactJoachim Kuebler, Dr
kuebler.joachim@mh-hannover.de+49-176-15329261

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026