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

NCT05778019 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2023-03-21

No results posted yet for this study

Summary

Despite appraisal of the Clavien-Dindo classification in the pediatric surgical literature, some criticize the transfer of the grading systems for adults in a pediatric cohort without modifications. In a recent study it has been shown that few items of the classification do not offer additional information in pediatric cohorts and organizational and management errors have been integrated, not being part of the initial proposal by Dindo et al.

In a group of pediatric and general surgeons, methodologists and statisticians of the ERNICA network the Clavien-Dindo classification has been modified for the application in pediatric surgery. The aim is to test and validate the novel Clavien-Madadi classification in a pediatric surgical cohort.

Conditions

  • Complication of Surgical Procedure

Interventions

OTHER

Case Scenarios of complications to be ranked / classified according to classifications (for the severity grading of events)

Test the feasibility, applicability and logic of a novel instrument for the grading of unexpected events in pediatric surgery (Clavien-Madadi classification) compared to the Clavien-Dindo classification for the grading of postoperative complications in general surgery

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Helsinki University Central Hospital

    collaborator OTHER

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER

  • Ospedale dei Bambini Milano

    collaborator UNKNOWN

  • University of Leipzig

    collaborator OTHER

  • Namik Kemal University School of Medicine, Tekirdag

    collaborator OTHER

  • Hannover Medical School

    lead OTHER

Eligibility

Min Age
1 Day
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-05-31
Completion
2023-07-31

Countries

  • Germany

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05778019 on ClinicalTrials.gov