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

Study Overview
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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.

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.

Official Title
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Comparison of Mid-term Results of Total Correction of Tetralogy of Fallot Between Preservation of Pulmonary Valve and Trans-annular Patching

Conditions
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Tetrology of Fallot

Intervention / Treatment
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* Procedure: TOF repair with trans-annular patch VS preservation of PV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective total correction of tetralogy of Fallot. Any age group. Normal pulmonay branches Exclusion Criteria: Patients associated with other congenital anomalies. Regarding PV morphology, patients with pulmonary atresia , absence of PV. Patients with anomalous coronary artery anatomy obstructs access to the RV Extra-cardiac illness that is expected to limit survival to less than 5 years.e.g active hepatitis or significant hepatic or renal disorders.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOF repair with preservation of PV<br>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. | Procedure: TOF repair with trans-annular patch VS preservation of PV<br>* One group study<br>|
| Experimental: TOF repair with trans-annular patch<br>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. | Procedure: TOF repair with trans-annular patch VS preservation of PV<br>* One group study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gender | Parameters will be measured include gender preoperatively | One week for preoperative assessment. | 
| Body weight | Parameters will be measured include body weight in kilograms preoperatively | One week for preoperative assessment. | 
| Height | Parameters will be measured include height in meters preoperatively | One week for preoperative assessment. | 
| Oxygen saturation , RV function | Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % preoperatively | One week for preoperative assessment. | 
| include median RVOT gradient and degree of PV stenosis | Parameters will be measured include median RVOT gradient in mmhg , degree of PV stenosis by peak gradient across the PV in mmhg preoperatively | One week for preoperative assessment. | 
| PV annulus and PV z-score | Parameters will be measured include median PV annulus diameter in mm , median PV Z-score diameter in mm preoperatively | One week for preoperative assessment. | 
| degree of PV regurge, degree of TR and RV size | Parameters will be measured include degree of PV regurge jet size by color doppler,degree of TR by jet area -central jets in cm^2 , RV size (RV diastolic area in cm^ , RV systolic area in cm^ ) preoperatively | One week for preoperative assessment. | 
| Age | Parameters will be measured include age in months preoperatively | One week for preoperative assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gender | Parameters will be measured include gender pre-discharge postoperative assessment. | Pre-discharge postoperative assessment within one month | 
| Body weight | Parameters will be measured include body weight in kilograms pre-discharge postoperative assessment. | Pre-discharge postoperative assessment within one month | 
| Height | Parameters will be measured include height in meters pre-discharge postoperative assessment. | Pre-discharge postoperative assessment within one month | 
| Oxygen saturation , RV function | Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % Pre-discharge postoperative assessment. | Pre-discharge postoperative assessment within one month | 
| Median RVOT gradient and degree of PV stenosis | Parameters will be measured include median RVOT gradient in mmhg , degree of PV stenosis by peak gradient across the PV in mmhg pre-discharge postoperative assessment. | Pre-discharge postoperative assessment within one month | 
| PV annulus and PV z-score | Parameters will be measured include median PV annulus diameter in mm , median PV Z-score diameter in mm pre-discharge postoperative assessment. | Pre-discharge postoperative assessment within one month | 
| degree of PV regurge, degree of TR and RV size | Parameters will be measured include degree of PV regurge jet size by color doppler,degree of TR by jet area -central jets in cm^2 , RV size (RV diastolic area in cm^ , RV systolic area in cm^ ) pre-discharge postoperative assessment. | Pre-discharge postoperative assessment within one month | 
| Median cross clamp time and CPB time | Parameters will be measured include Median cross clamp time in minutes and CPB time in minutes pre-discharge postoperative assessment. | Pre-discharge postoperative assessment within one month | 
| ICU stay | Parameters will be measured include ICU stay days pre-discharge postoperative assessment. | Pre-discharge postoperative assessment within one month | 
| Time till weaning from mechanical ventilator | Parameters will be measured include Time till weaning from mechanical ventilator in hours pre-discharge postoperative assessment. | Pre-discharge postoperative assessment within one month | 
| Age | Parameters will be measured include age in months pre-discharge postoperative assessment. | Pre-discharge postoperative assessment within one month |