Comparison of Mid-term Results of Total Correction of TOF Between Preservation of PV and Trans-annular Patch.

Assiut University

Status: Unknown

Conditions: Tetrology of Fallot

Treatments: Procedure: TOF repair with trans-annular patch VS preservation of PV

Study type: Interventional

Funder types: Other

Identifiers

NCT03732742

TOF repair

Details and patient eligibility

About

To compare of mid-term results of total correction of tetralogy of fallot between preservation of pulmonary valve and trans-annular patching , thus avoiding PV regurgitation during TOF repair , this will determine the value of this procedure over trans-annular patching regarding to right ventricular performance.

Full description

Surgical repair of congenital lesions associated with right ventricular outflow tract obstruction frequently requires the destruction of pulmonary valve (PV) competents including the pulmonary annulas. The resulatnt pulmonary insufficiency may lead to late functional deterioration of right ventricular performance. Acute right ventricular dysfunction has been associated with poor pulmonary runoff, tricuspid valve regurgitaion and pulmonary hypertension. Preservation of PV comptence may prevent both early and late right ventricular failure. Total repair of tetralogy of fallot is a corrective surgical procedure that involves closure of the ventricular septal defect (VSD) and relief of right ventricular outflow tract (RVOT) obstruction. The surgeon must decide whether the right ventricular outflow tract size will be sufficient to allow for the entire cardiac output to traverse it without causing extreme elevation in right ventricular pressure or will go for trans-annular patch. Recently interest has shifted to preserving the integrity of the pulmonary valve annulus thus avoiding pulmonary valve regurgitation.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients undergoing elective total correction of tetralogy of Fallot.
2. Any age group.
3. Normal pulmonay branches

Exclusion criteria

1. Patients associated with other congenital anomalies.
2. Regarding PV morphology, patients with pulmonary atresia , absence of PV.
3. Patients with anomalous coronary artery anatomy obstructs access to the RV
4. Extra-cardiac illness that is expected to limit survival to less than 5 years.e.g active hepatitis or significant hepatic or renal disorders.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

TOF repair with preservation of PV

Experimental group

Description:

Surgical intervention by repair of Tetralogy of Fallot with preservation of pulmonary valve, recently interested has shifted to preserving the integrity of the pulmonary valve.

Treatment:

Procedure: TOF repair with trans-annular patch VS preservation of PV

TOF repair with trans-annular patch

Experimental group

Description:

Surgical intervention by repair of Tetralogy of Fallot with trans-annular patch, right ventricular hypertrophy, right ventricular dilatation and pulmonary vavle regurgitation has been recognized as one of the most important risk factors for both right and left ventricular performance after the repair of Tetralogy of Fallot.

Treatment:

Procedure: TOF repair with trans-annular patch VS preservation of PV