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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00268099
Enrollment
75
Registered
2005-12-22
Start date
2005-05-31
Completion date
2006-11-30
Last updated
2012-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Disorders

Keywords

pediatric, cardiac, repair of right to left shunt lesions, Tetralogy of Fallot defects

Brief summary

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.

Detailed 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

Interventions

None listed

Sponsors

Children's Healthcare of Atlanta
Lead SponsorOTHER

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026