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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Complication of Surgical Procedure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Comparison of the Clavien-Dindo and Clavien-Madadi classification

Eligibility Criteria

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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