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Postoperative adverse events may be associated with substantial morbidity and mortality. However, inconsistent definitions of complications and unexpected events have limited accurate analysis of surgical outcomes. In 2004, the Clavien-Dindo classification for postoperative complications has been introduced and has since then been validated in numerous studies, with more than 20.000 citations.
Despite the appraisal of the Clavien-Dindo classification in the pediatric surgical literature, some criticize the transfer of grading systems for adults into a pediatric cohort without modification or validation. In a recent study we have shown that few items of the classification do not offer relevant information in pediatric cohorts and we have added organizational and management errors, not integrated in the initial proposal by Dindo et al. Especially, the variety of options for the management of complications based on institutional protocols and logistics is emphasized and a more focused and detailed assessment of the invasiveness of procedures in children is introduced.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel severity grading system of unexpected events in pediatric surgery | Diagnostic Test | Classification of unexpected events according to the Clavien-Madadi classification for pediatric surgical patients and simultaneously the non-modified Clavien-Dindo classification in more than 10.000 patients who have been treated at a single center from 2017 to 2022. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Categorization of adverse events | Events associated with surgical/non-surgical interventions and events not associated with interventions such as organizational problems, management problems or underlying disease were differentiated. | Through study completion, an average of 3 years |
| Classification of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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Data on all patients (preterm infants to 18 years of age) who experienced unexpected events at the Department of Pediatric Surgery Hannover Medical School from 1st January 2017 to 31st December 2021 were documented prospectively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omid Madadi-Sanjani, Dr | Contact | +49-176-15329053 | madadi-sanjani.omid@mh-hannover.de | |
| Joachim Kuebler, Dr | Contact | +49-176-15329261 | kuebler.joachim@mh-hannover.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Recruiting | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35022674 | Background | 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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According to the Clavien-Dindo classification |
| Through study completion, an average of 3 years |
| Classification of adverse events using a novel instrument | According to the Clavien-Madadi classification | Through study completion, an average of 3 years |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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