Severity Grading of Unexpected Events in Pediatric Surgery

Complication of Surgical Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04827641
• Other study ID #: 2739-2015
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2021
• Source: Hannover Medical School
• Contact: Omid Madadi-Sanjani, Dr
• Phone: +49-511-5329053
• Email: madadi-sanjani.omid[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 670
• Est. completion date: July 1, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication of Surgical Procedure

Intervention

Other:
• Severity 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.

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View Citation

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. — View Citation

Staiger RD, Cimino M, Javed A, Biondo S, Fondevila C, Périnel J, Aragão AC, Torzilli G, Wolfgang C, Adham M, Pinto-Marques H, Dutkowski P, Puhan MA, Clavien PA. The Comprehensive Complication Index (CCI®) is a Novel Cost Assessment Tool for Surgical Procedures. Ann Surg. 2018 Nov;268(5):784-791. doi: 10.1097/SLA.0000000000002902. — View Citation

Staiger RD, Gerns E, Castrejón Subirà 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. — View Citation

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. Review. — View Citation

Zoeller C, Kuebler JF, Ure BM, Brendel J. Incidence of complications, organizational problems, and errors: Unexpected events in 1605 patients. J Pediatr Surg. 2020 Dec 13. pii: S0022-3468(20)30899-X. doi: 10.1016/j.jpedsurg.2020.12.004. [Epub ahead of pri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	All adverse events were prospectively documented	Through study completion, an average of 3 years
Secondary	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
Secondary	Classification of adverse events	According to the Clavien-Dindo-, T92-, contracted Accordion-, Extended Accordion- and MSKCC-Classification	Through study completion, an average of 3 years
Secondary	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