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

Sponsor
Hannover Medical School (Other)
Overall Status
Recruiting
CT.gov ID
NCT05277441
Collaborator
(none)
10,000
1
72
138.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Novel severity grading system of unexpected events in pediatric surgery

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Novel Classification for the Assessment and Grading of Unexpected Events in Pediatric Surgery: The Clavien-Madadi Classification
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events [Through study completion, an average of 3 years]

Secondary Outcome Measures

  1. 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.

  2. Classification of adverse events [Through study completion, an average of 3 years]

    According to the Clavien-Dindo classification

  3. Classification of adverse events using a novel instrument [Through study completion, an average of 3 years]

    According to the Clavien-Madadi classification

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 18 Years
Sexes Eligible for Study:
All
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hannover Medical School Hannover Lower Saxony Germany 30625

Sponsors and Collaborators

  • Hannover Medical School

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Omid Madadi-Sanjani, Dr., Principal investigator, Consultant Pediatric Surgery, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT05277441
Other Study ID Numbers:
  • 9557_BO_K_2021
First Posted:
Mar 14, 2022
Last Update Posted:
Mar 14, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2022