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NCT05546983 Clinical Trial

How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?

Congenital Heart Disease in Children Clinical Trial

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Official title:
How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05546983
Other study ID # 8717
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date September 1, 2023

Study information
Verified date December 2023
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 189
Est. completion date September 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers
Gender All
Age group 1 Year to 17 Years
Eligibility Inclusion criteria: - 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. Exclusion criteria: - 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service de Pédiatrie 1 - CHU de Strasbourg - France Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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