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Severity Grading of Unexpected Events in Pediatric Surgery

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04827641
Enrollment
670
Registered
2021-04-01
Start date
2017-01-01
Completion date
2023-07-01
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Surgical Procedure

Keywords

complications, unexpected events, severity grading systems

Brief summary

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.

Interventions

OTHERSeverity 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.

Sponsors

Hannover Medical School
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of adverse eventsThrough study completion, an average of 3 yearsAll adverse events were prospectively documented

Secondary

MeasureTime frameDescription
Categorization of adverse eventsThrough study completion, an average of 3 yearsEvents associated with surgical/non-surgical interventions and events not associated with interventions such as organizational problems, management problems or underlying disease were differentiated.
Classification of adverse eventsThrough study completion, an average of 3 yearsAccording to the Clavien-Dindo-, T92-, contracted Accordion-, Extended Accordion- and MSKCC-Classification
Calculation of the Comprehensive Complication Index (CCI®)3 monthsUsing an online tool based on the protocol by Staiger et al.(http://www.cci.assessurgery.com).

Countries

Germany

Contacts

Primary ContactOmid Madadi-Sanjani, Dr
madadi-sanjani.omid@mh-hannover.de+49-511-5329053

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026