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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Helsinki University Central Hospital | OTHER |
| Great Ormond Street Hospital for Children NHS Foundation Trust | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Case Scenarios of complications to be ranked / classified according to classifications (for the severity grading of events) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Recruiting | Hanover | Lower Saxony | 30655 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26628204 | Result | 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. | |
| 35022674 | Result | 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. |
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No individual participant data is necessary in our protocol. We will be focussing on constructed case scnearios, not including any specific patient data at all
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| Ospedale dei Bambini Milano |
| UNKNOWN |
| University of Leipzig | OTHER |
| Namik Kemal University School of Medicine, Tekirdag | OTHER |
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| Three months |
| 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 |
| 36291526 | Result | 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. |
| 36720251 | Result | 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. |
| 15273542 | Result | 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. |