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

H

Hannover Medical School (MHH)

Status

Unknown

Conditions

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

Treatments

Diagnostic Test: Novel severity grading system of unexpected events in pediatric surgery

Study type

Observational

Funder types

Other

Identifiers

NCT05277441
9557_BO_K_2021

Details and patient eligibility

About

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.

Enrollment

10,000 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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;

Trial contacts and locations

1

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Central trial contact

Joachim Kuebler, Dr; Omid Madadi-Sanjani, Dr

Data sourced from clinicaltrials.gov

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