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

March 3, 2022 updated by: Omid Madadi-Sanjani, Dr., Hannover Medical School

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Diagnostic test: Novel severity grading system of unexpected events in pediatric surgery

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Omid Madadi-Sanjani, Dr
Phone Number: +49-176-15329053
Email: madadi-sanjani.omid@mh-hannover.de

Study Contact Backup

Name: Joachim Kuebler, Dr
Phone Number: +49-176-15329261
Email: kuebler.joachim@mh-hannover.de

Study Locations

Germany
- Lower Saxony
  - Hannover, Lower Saxony, Germany, 30625
    - Recruiting
    - Hannover Medical School
    - Contact:
      
      Omid Madadi-Sanjani
      
      Phone Number: +4917615329053
      
      Email: madadi-sanjani.omid@mh-hannover.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events Time Frame: Through study completion, an average of 3 years	Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Categorization of adverse events Time Frame: 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.	Through study completion, an average of 3 years
Classification of adverse events Time Frame: Through study completion, an average of 3 years	According to the Clavien-Dindo classification	Through study completion, an average of 3 years
Classification of adverse events using a novel instrument Time Frame: Through study completion, an average of 3 years	According to the Clavien-Madadi classification	Through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

March 3, 2022

First Posted (ACTUAL)

March 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)