NCT04827641
Unknown
Not Applicable
Severity Grading of Unexpected Events in Pediatric Surgery - Evaluation of Five Classification Systems and the Comprehensive Complication Index (CCI®)
Hannover Medical School1 site in 1 country670 target enrollmentStarted: January 1, 2017Last updated:
ConditionsComplication of Surgical Procedure
Overview
- Phase
- Not Applicable
- Sponsor
- Hannover Medical School
- Enrollment
- 670
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 0 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: Through study completion, an average of 3 years
All adverse events were prospectively documented
Secondary Outcomes
- Classification of adverse events(Through study completion, an average of 3 years)
- Calculation of the Comprehensive Complication Index (CCI®)(3 months)
- Categorization of adverse events(Through study completion, an average of 3 years)
Investigators
Omid Madadi-Sanjani, Dr.
Consultant, Center of Pediatric Surgery
Hannover Medical School
Study Sites (1)
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