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

March 8, 2023 updated by: Hannover Medical School

Validation of Clavien-Madadi Classification for the Grading of Unexpected Events in Pediatric Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Based on the protocol by Dindo et al. for the assessment of the international acceptability and reproducibility of the Clavien-Dindo classification, the aim is to circulate case scenarios (of complications/ unexpected events) within the ERNICA (European Reference Network for Rare Inherited Congenital Anomalies) network. Those case scenarios (15-20) should be graded by the respondents according to the Clavien-Dindo and Clavien-Madadi classification and preferences for future practice should be reported.

Milestones

  1. All members of the working group send the PI´s 1-2 case scenarios with unexpected events in the management and treatment of neonates (preferably congenital diseases) and children for each grade of the Clavien-Madadi classification
  2. All case scenarios will be circulated within the working group and will be ranked with a Likert scale (1 not accurate - 5 accurate) regarding the plausibility for an international survey
  3. A final proposal of 15-20 case scenarios will be circulated within the working group
  4. Circulating the case scenarios and the additional questionnaire via the ERNICA email distribution system and newsletter

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

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

Study Locations

  • Germany
    • Lower Saxony
      • Hannover, Lower Saxony, Germany, 30655
        • Recruiting
        • Hannover Medical School
        • Contact:

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 day to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The constructed case scenarios will especially focus on congenital diseases, however, the spectrum of pediatric surgery (age: preterm infants to 17 years of age) will be included in the scenarios (if necessary)

Description

Inclusion Criteria:

  • Case scenarios of unexpected events
  • Case scenarios on neonatal surgery
  • Case scenarios on congenital malformations
  • Case scenarios with (re-)interventions
  • Case scenarios with organ impairment
  • Case scenarios with fatal result

Exclusion Criteria:

  • Complex constructed case scenarios
  • Case scenarios with adult patients
  • Case scenarios with multiple events

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case Scenarios
No personal patient information is shared. The circulated case scenarios within the network will be constructed cases from the clinical practice, to serve representatively
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
Other Names:
  • Comparison of the Clavien-Dindo and Clavien-Madadi classification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grading according to the Clavien-Madadi classification
Time Frame: Three months

Grading of constructed case scenarios (by an international working group).

Grading according to the Clavien-Madadi classification:

Grade Ia - organizational and management errors Grade Ib - any deviation from the planned clinical course Grade II - pharmacological treatment Grade IIIa - Re-interventions (minimally-invasive) Grade IIIb - Re-interventions (laparotomy and / or thoracotomy) Grade IV - multiorgan dysfunction Grade V - death
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grading according to the Clavien-Dindo classification
Time Frame: Three months

Grading of constructed case scenarios (by an international working group)

Grading according to the Clavien-Dindo classification:

Grade I - any deviation from the planned postoperative course Grade II - pharmacological treatment Grade IIIa - Re-interventions not under general anesthesia Grade IIIb - Re-interventions under general anesthesia Grade IVa - single-organ dysfunction Grade IVb - multiorgan dysfunction Grade V - death
Three months
Comparison of Clavien-Madadi and Clavien-Dindo classification
Time Frame: Three months
For each case scenario the respondents will have the option to select the superior classification (or specify no difference)
Three months

Collaborators and Investigators

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

Sponsor

Hannover Medical School

Collaborators

Karolinska Institutet
Helsinki University Central Hospital
University of Leipzig
Great Ormond Street Hospital for Children NHS Foundation Trust
Namik Kemal University School of Medicine, Tekirdag
Ospedale dei Bambini Milano

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

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)

December 1, 2022

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9557_BO_K_2021_2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data is necessary in our protocol. We will be focussing on constructed case scnearios, not including any specific patient data at all

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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