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

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tetrology of Fallot

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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TOF repair with preservation of PV

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.

Group Type EXPERIMENTAL

TOF repair with trans-annular patch VS preservation of PV

Intervention Type PROCEDURE

One group study

TOF repair with trans-annular patch

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.

Group Type EXPERIMENTAL

TOF repair with trans-annular patch VS preservation of PV

Intervention Type PROCEDURE

One group study

Interventions

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TOF repair with trans-annular patch VS preservation of PV

One group study

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No