Severity Grading of Unexpected Events in Pediatric Surgery

• Conditions: Complication of Surgical Procedure

• Registration Number: NCT04827641
• Lead Sponsor: Hannover Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-30
• Last Update Submitted: 2021-03-30
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 670

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Through study completion, an average of 3 years	All adverse events were prospectively documented

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Lower Saxony, Germany