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Optimal Timing for Repair of Right-to-Left Shunt Lesions

C

Children's Healthcare of Atlanta

Status

Terminated

Conditions

Congenital Disorders

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

The primary aim of this study is to determine the optimal timing for repair of right-to-left shunt lesions such as Tetralogy of Fallot defects.

The secondary aim being define the criteria for failing medical therapy.

Full description

In the past, children with right-to-left shunt lesions such as Tetralogy of Fallot defects were palliated with a systemic to pulmonary artery shunt. This prevented cyanosis while the child grew to a size where complete repair could be undertaken. With the improvements in surgical technique and critical care, there is a push to do a primary complete repair for these defects at younger and younger ages. These operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary cyanosis and hypoxemia.

Study Design and Methodology:

Retrospective chart review - approximately 75 patients

Preoperative data:

Diagnosis

Operative data:

Age and weight at surgery Type of surgical procedure Whether pulmonary valve is spared

Postoperative data:

Length of time on ventilator Length of time on inotropes Length of ICU stay Length of hospital stay Complications

Enrollment

75 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients in the congenital surgery database who have undergone repair of a Tetralogy of Fallot defect

Exclusion criteria

  • those who do not meet inclusion criteria

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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