How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?

NCT ID: NCT05546983

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Disease in Children

Keywords

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Congenital Heart Disease Abnormality in newborns

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Pédiatrie 1 - CHU de Strasbourg - France

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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8717

Identifier Type: -

Identifier Source: org_study_id