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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Severity Grading assessment in children with perioperative unexpected events | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | All adverse events were prospectively documented | Through study completion, an average of 3 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Data on all patients (preterm infants to 18 years of age) who experienced unexpected events at the Department of Pediatric Surgery Hannover Medical School from 1st January 2017 to 30th November 2020 were documented prospectively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omid Madadi-Sanjani, Dr | Contact | +49-511-5329053 | madadi-sanjani.omid@mh-hannover.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Recruiting | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26628204 | Background | Sethi MV, Zimmer J, Ure B, Lacher M. Prospective assessment of complications on a daily basis is essential to determine morbidity and mortality in routine pediatric surgery. J Pediatr Surg. 2016 Apr;51(4):630-3. doi: 10.1016/j.jpedsurg.2015.10.052. Epub 2015 Oct 27. | |
| 30272585 | Background | Staiger RD, Cimino M, Javed A, Biondo S, Fondevila C, Perinel J, Aragao AC, Torzilli G, Wolfgang C, Adham M, Pinto-Marques H, Dutkowski P, Puhan MA, Clavien PA. The Comprehensive Complication Index (CCI(R)) is a Novel Cost Assessment Tool for Surgical Procedures. Ann Surg. 2018 Nov;268(5):784-791. doi: 10.1097/SLA.0000000000002902. |
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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 |
| 32925252 | Background | Staiger RD, Gerns E, Castrejon Subira M, Domenghino A, Puhan MA, Clavien PA. Can Early Postoperative Complications Predict High Morbidity and Decrease Failure to Rescue Following Major Abdominal Surgery? Ann Surg. 2020 Nov;272(5):834-839. doi: 10.1097/SLA.0000000000004254. |
| 15273542 | Background | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |
| 19638919 | Background | Strasberg SM, Linehan DC, Hawkins WG. The accordion severity grading system of surgical complications. Ann Surg. 2009 Aug;250(2):177-86. doi: 10.1097/SLA.0b013e3181afde41. |
| 33353740 | Result | Zoeller C, Kuebler JF, Ure BM, Brendel J. Incidence of complications, organizational problems, and errors: Unexpected events in 1605 patients. J Pediatr Surg. 2021 Oct;56(10):1723-1727. doi: 10.1016/j.jpedsurg.2020.12.004. Epub 2020 Dec 13. |