Severity Grading of Unexpected Events in Pediatric Surgery

Study Overview
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Brief Summary
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Data on all patients who experienced unexpected events at the Department of Pediatric Surgery Hannover Medical School from 1st January 2017 to 30th November 2020 were documented prospectively. The department represents the only tertiary academic institution of the german province of Lower-Saxony (8 million inhabitants). The clinical spectrum of the department includes surgery of the neonate, gastrointestinal, hepatobiliary, thoracic and oncological surgery and pediatric urology.

Official Title
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Severity Grading of Unexpected Events in Pediatric Surgery - Evaluation of Five Classification Systems and the Comprehensive Complication Index (CCI®)

Conditions
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Complication of Surgical Procedure

Intervention / Treatment
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* Other: Severity Grading assessment in children with perioperative unexpected events


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with unexpected events during the in-hospital stay, in outpatient clinics and in the pediatric emergency department Informed consent was obtained from the legal guardian´s at admission Exclusion Criteria: If no informed consent was obtained from the legal guardian´s at admission

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Severity Grading assessment in children with perioperative unexpected events|Systematic documentation of all unexpected events was carried out by designated team members during daily routine team conferences. Briefly, on-call team members and all other staff reported on any unexpected event that had occurred within the previous 24 hours, after weekends during the past 72 hours. Events included those that had occurred in inpatients, outpatients and in the pediatric emergency department. Data concerning each event included patient demographics, diagnoses, treatments/operations and types of events.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | All adverse events were prospectively documented | Through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | According to the Clavien-Dindo-, T92-, contracted Accordion-, Extended Accordion- and MSKCC-Classification | Through study completion, an average of 3 years | 
| Calculation of the Comprehensive Complication Index (CCI®) | Using an online tool based on the protocol by Staiger et al.(http://www.cci.assessurgery.com). | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complications, unexpected events, severity grading systems