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

NCT05277441 | Unknown DMC

• 1 other identifier: 9557_BO_K_2021
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Through study completion, an average of 3 years

Secondary Outcomes (3)

• Categorization of adverse events

  Through study completion, an average of 3 years

• 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

Interventions

Novel severity grading system of unexpected events in pediatric surgery DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Data on all patients (preterm infants to 18 years of age) who experienced unexpected events at the Department of Pediatric Surgery Hannover Medical School from 1st January 2017 to 31st December 2021 were documented prospectively.

You may qualify if:

• All patients with unexpected events within the study period, treated at the department of pediatric surgery (preterms - 17 years of age), Hannover Medical School

You may not qualify if:

• None;

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Related 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(R)). BJS Open. 2021 Nov 9;5(6):zrab138. doi: 10.1093/bjsopen/zrab138.

  PMID: 35022674 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Omid Madadi-Sanjani, Dr

CONTACT

+49-176-15329053; madadi-sanjani.omid@mh-hannover.de

Joachim Kuebler, Dr

CONTACT

+49-176-15329261; kuebler.joachim@mh-hannover.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Consultant Pediatric Surgery

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 14, 2022
• Study Start: January 1, 2017
• Primary Completion: December 31, 2022
• Study Completion: January 1, 2023
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)