Severity Grading of Unexpected Events in Pediatric Surgery

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

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 Overview

• Status: Recruiting
• Conditions: Complication of Surgical Procedure
• Intervention / Treatment: Other: Severity Grading assessment in children with perioperative unexpected events

• Study Type: Observational
• Enrollment (Anticipated): 670

Contacts and Locations

• Study Contact: Name: Omid Madadi-Sanjani, Dr; Phone Number: +49-511-5329053; Email: madadi-sanjani.omid@mh-hannover.de

Study Locations

• Germany
  • Lower Saxony
    • Hannover, Lower Saxony, Germany, 30625
      • Recruiting
      • Hannover Medical School
      • Contact: Omid Madadi-Sanjani, Dr; Phone Number: +49-511-5329053; Email: madadi-sanjani.omid@mh-hannover.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	All adverse events were prospectively documented	Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hannover Medical School

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: complications; unexpected events; severity grading systems
• Other Study ID Numbers: 2739-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No