Intervention timing and outcome for TOF
Research type
Research Study
Full title
A study comparing the outcomes of treatment of Tetralogy of Fallot in patients aged under 3 months and over 3 months matched by the type of intervention.
IRAS ID
185623
Contact name
Nicola Viola
Contact email
Duration of Study in the UK
0 years, 5 months, 8 days
Research summary
Tetralogy of Fallot is a congenital cyanotic heart defect. It is classically described as a collection of four coexisting heart abnormalities:
1. A VSD, which is a hole in the heart between the ventricles.
2. Obstruction to blood flow exiting the right ventricle.
3. Thickening of the wall of the right ventricle.
4. An aorta which overrides the VSD.The symptoms of Tetralogy of Fallot worsen with age and surgical intervention is required.
Timing of the surgical treatment of Tetralogy of Fallot depends upon the severity of the defect, presence of co-morbidities and institutional preference. Treatment of severe Tetralogy of Fallot at an early age has contrasting opinion: either initial palliation, allowing the child to grow before performing a complete repair later, or carry out a complete repair almost immediately.
This study will test the hypothesis that very early (under 3 months) complete repair may improve survival and future rates of re-intervention when compared with repair performed later in life. Twenty-five patients aged over 3months at time of surgery and twenty-five patients under 3 months of age will be selected and matched by type of intervention and the short-midterm outcomes will be compared. The study will take place at the cardiothoracic surgery department UHS using internal, user code-protected databases (heartsuite, edocs). It may involve a review of paper case notes when electronic data are incomplete.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/1469
Date of REC Opinion
17 Aug 2015
REC opinion
Favourable Opinion