Clinical trial NCT05778019: Validating the Novel Classification for the Assessment and Grading of Unexpected Events in Pediatric Surgery: The Clavien-Madadi Classification
Official title: Validation of Clavien-Madadi Classification for the Grading of Unexpected Events in Pediatric Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complication of Surgical Procedure
Keywords: Complications
Unexpected events
Severity Grading Systems
Classifications
Clavien-Madadi
Clavien-Dindo
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Helsinki University Central Hospital
name: Great Ormond Street Hospital for Children NHS Foundation Trust
name: Ospedale dei Bambini Milano
name: University of Leipzig
name: Namik Kemal University School of Medicine, Tekirdag
First posted: 2023-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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)

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

Eligibility criteria: 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

Primary outcomes:
measure: Grading according to the Clavien-Madadi classification
timeFrame: Three months
Secondary outcomes:
measure: Grading according to the Clavien-Dindo classification
timeFrame: Three months
measure: Comparison of Clavien-Madadi and Clavien-Dindo classification
timeFrame: Three months
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Lower Saxony
Study officials:
References:
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 2015 Oct 27.
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 Open. 2021 Nov 9;5(6):zrab138. doi: 10.1093/bjsopen/zrab138.
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 (Basel). 2022 Oct 20;9(10):1590. doi: 10.3390/children9101590.
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 Apr;33(2):105-113. doi: 10.1055/s-0043-1760835. Epub 2023 Jan 31.
citation: 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.