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

Recruiting

• Conditions: Complication of Surgical Procedure
• Interventions: Other: Case Scenarios of complications to be ranked / classified according to classifications (for the severity grading of events)

• Registration Number: NCT05778019
• Lead Sponsor: Hannover Medical School

Brief 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.

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 Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-02-27
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-08
• Last Update Submitted: 2023-03-08
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21
• Primary Completion: 2023-05-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case Scenarios	Case Scenarios of complications to be ranked / classified according to classifications (for the severity grading of events)	No personal patient information is shared. The circulated case scenarios within the network will be constructed cases from the clinical practice, to serve representatively

Primary Outcome Measures

Name	Time	Method
Grading according to the Clavien-Madadi classification	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

Secondary Outcome Measures

Name	Time	Method
Grading according to the Clavien-Dindo classification	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
Comparison of Clavien-Madadi and Clavien-Dindo classification	Three months	For each case scenario the respondents will have the option to select the superior classification (or specify no difference)

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Lower Saxony, Germany