How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?

NCT05546983 | Completed

• 1 other identifier: 8717
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

Congenital heart disease is a common abnormality in newborns. The marked improvement in the surgical management of congenital heart disease has led to a reduction in postoperative mortality, historically a quality criterion for surgical and resuscitation management. With the improvement of medical knowledge and surgical techniques, mortality is no longer a single quality criterion for a center and the search for other quality criteria is essential.

Conditions

Congenital Heart Disease in Children

Keywords

Congenital Heart Disease; Abnormality in newborns

Outcome Measures

Primary Outcomes (1)

• Retrospective analysis of the quality criteria described in the literature after pediatric cardiac surgery by studying their behavior within a local cohort within the University Hospitals of Strasbourg

  Files analysed retrospectively from January 01, 2010 to March 31, 2022 will be examined

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Minor patients, under the age of 18 operated at the HUS between 01/01/2010 and 03/31/2022 for transposition surgery of the great vessels (arterial switch) with or without CIV; or isolated ventricular septal closure

You may qualify if:

• Minor patients, under the age of 18
• operated at the HUS between 01/01/2010 and 03/31/2022 for transposition surgery of the great vessels (arterial switch) with or without CIV; or isolated ventricular septal closure
• Child or holders of parental authority who do not object to the reuse of their data for scientific research purposes.

You may not qualify if:

• Transposition surgery of the great vessels associated with coarctation of the aorta, pulmonary stenosis or any other complex malformation
• Surgical technique different from the arterial switch for the transpositions of the great vessels
• Closure of interventricular communication associated with another complex heart malformation (tetralogy of Fallot, atrioventricular canal, right ventricle with double outlet, etc.)
• Child or holders of parental authority who have expressed their opposition to the reuse of their data for scientific research purposes.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Pédiatrie 1 - CHU de Strasbourg - France

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: September 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

FR (1)