A Novel Classification for the Assessment and Grading of Unexpected Events in Pediatric Surgery: The Clavien-Madadi Classification
Overview
- Phase
- Not Applicable
- Sponsor
- Hannover Medical School
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 0 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: Through study completion, an average of 3 years
Secondary Outcomes
- Classification of adverse events(Through study completion, an average of 3 years)
- Classification of adverse events using a novel instrument(Through study completion, an average of 3 years)
- Categorization of adverse events(Through study completion, an average of 3 years)
Investigators
Omid Madadi-Sanjani, Dr.
Principal investigator, Consultant Pediatric Surgery
Hannover Medical School