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

• Conditions: Complication,Postoperative; Complication of Medical Care; Complication of Surgical Procedure; Complication of Anesthesia

• Registration Number: NCT05277441
• Lead Sponsor: Hannover Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2022-02-23
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-03
• Last Update Submitted: 2022-03-03
• Study First Posted: 2022-03-14
• Last Update Posted: 2022-03-14
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Through study completion, an average of 3 years

Secondary Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Lower Saxony, Germany