Severity Grading of Unexpected Events in Pediatric Surgery

NCT04827641 | Unknown

• 1 other identifier: 2739-2015
• Study Type: observational
• Target: 670
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication of Surgical Procedure

Keywords

complications; unexpected events; severity grading systems

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  All adverse events were prospectively documented

  Through study completion, an average of 3 years

Secondary Outcomes (3)

• Categorization of adverse events

  Through study completion, an average of 3 years

• Classification of adverse events

  Through study completion, an average of 3 years

• Calculation of the Comprehensive Complication Index (CCI®)

  3 months

Interventions

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.

Also known as: According to Clavien-Dindo Classification, According to T92 Classification, According to contracted Accordion Classification, According to extended Accordion Classification, According to MSKCC Classification, According to Comprehensive Complication Index (CCI®)

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• If no informed consent was obtained from the legal guardian´s at admission

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Related Publications (6)

• 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.

  PMID: 26628204 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.

  PMID: 30272585 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.

  PMID: 32925252 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.

  PMID: 15273542 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.

  PMID: 19638919 BACKGROUND

• 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.

  PMID: 33353740 RESULT

Central Study Contacts

Omid Madadi-Sanjani, Dr

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Center of Pediatric Surgery

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: January 1, 2017
• Primary Completion: December 31, 2022
• Study Completion: July 1, 2023
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)