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

• Sponsor: Hannover Medical School (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05778019
• Collaborator: Karolinska Institutet (Other), Helsinki University Central Hospital (Other), Great Ormond Street Hospital for Children NHS Foundation Trust (Other), Ospedale dei Bambini Milano (Other), University of Leipzig (Other), Namik Kemal University School of Medicine, Tekirdag (Other)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complication of Surgical Procedure	Other: Case Scenarios of complications to be ranked / classified according to classifications (for the severity grading of events)

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 Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Validation of Clavien-Madadi Classification for the Grading of Unexpected Events in Pediatric Surgery
• Actual Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

Arm

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hannover Medical School	Hannover	Lower Saxony	Germany	30655

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hannover Medical School
• ClinicalTrials.gov Identifier: NCT05778019
• Other Study ID Numbers: 9557_BO_K_2021_2
• First Posted: Mar 21, 2023
• Last Update Posted: Mar 21, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hannover Medical School: Complications; Unexpected events; Severity Grading Systems; Classifications; Clavien-Madadi; Clavien-Dindo

Study Results

No Results Posted as of Mar 21, 2023