Severity Grading of Unexpected Events in Pediatric Surgery

Hannover Medical School670 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

670

Conditions

Complication of Surgical Procedure

Interventions

Severity Grading assessment in children with perioperative unexpected eventsOTHER

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.

Eligibility

Sex: ALLMin age: 0 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hannover Medical School

Hanover, Lower Saxony, Germany

RECRUITING

Outcomes

Primary Outcomes

Incidence of adverse events

All adverse events were prospectively documented

Time frame: Through study completion, an average of 3 years

Secondary Outcomes

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.

Time frame: 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

Time frame: 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).

Time frame: 3 months

Central Contacts

Omid Madadi-Sanjani, Dr

CONTACT

+49-511-5329053 madadi-sanjani.omid@mh-hannover.de

Data from ClinicalTrials.gov

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