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

Complication of Surgical Procedure Clinical Trial

— ComPedS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778019
• Other study ID #: 9557_BO_K_2021_2
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2023
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication of Surgical Procedure

Intervention

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

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover	Lower Saxony

Sponsors (7)

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

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. — View Citation

Madadi-Sanjani O, Brendel J, Kuebler JF, Ure BM. Definition, Documentation, and Classification of Complications in Pediatric Surgical Literature-A Plea for Standardization. Eur J Pediatr Surg. 2023 Jan 31. doi: 10.1055/s-0043-1760835. Online ahead of prin — View Citation

Madadi-Sanjani O, Brendel J, Uecker M, Pfister ED, Baumann U, Ohlendorf J, Kuebler JF. Accumulation of Postoperative Unexpected Events Assessed by the Comprehensive Complication Index(R) as Prognostic Outcome Parameters for Kasai Procedure. Children (Base — View Citation

Madadi-Sanjani O, Zoeller C, Kuebler JF, Hofmann AD, Dingemann J, Wiesner S, Brendel J, Ure BM. Severity grading of unexpected events in paediatric surgery: evaluation of five classification systems and the Comprehensive Complication Index (CCI(R)). BJS O — View Citation

Sethi MV, Zimmer J, Ure B, Lacher M. Prospective assessment of complications on a daily basis is essential to determine morbidity and mortality in routine pediatric surgery. J Pediatr Surg. 2016 Apr;51(4):630-3. doi: 10.1016/j.jpedsurg.2015.10.052. Epub 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grading according to the Clavien-Madadi classification	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	Grading according to the Clavien-Dindo classification	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
Secondary	Comparison of Clavien-Madadi and Clavien-Dindo classification	For each case scenario the respondents will have the option to select the superior classification (or specify no difference)	Three months