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

Complication of Surgical Procedure Clinical Trial

— ComPedS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05277441
• Other study ID #: 9557_BO_K_2021
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: January 1, 2023

Study information

• Verified date: March 2022
• Source: Hannover Medical School
• Contact: Omid Madadi-Sanjani, Dr
• Phone: +49-176-15329053
• Email: madadi-sanjani.omid[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 1, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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;

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Madadi-Sanjani O, Zoeller C, Kuebler JF, Hofmann AD, Dingemann J, Wiesner S, Brendel J, Ure BM. Severity grading of unexpected events in paediatric surgery: evaluation of five classification systems and the Comprehensive Complication Index (CCI®). BJS Open. 2021 Nov 9;5(6). pii: zrab138. doi: 10.1093/bjsopen/zrab138. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Through study completion, an average of 3 years
Secondary	Categorization of adverse events	Events associated with surgical/non-surgical interventions and events not associated with interventions such as organizational problems, management problems or underlying disease were differentiated.	Through study completion, an average of 3 years
Secondary	Classification of adverse events	According to the Clavien-Dindo classification	Through study completion, an average of 3 years
Secondary	Classification of adverse events using a novel instrument	According to the Clavien-Madadi classification	Through study completion, an average of 3 years