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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hannover Medical School

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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