An interventional study of TOF repair with trans-annular patch VS preservation of PV in Tetrology of Fallot, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2018-11-07.
Sponsored by Assiut University · Not applicable, Interventional, and Prevention
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.
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.
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Exclusion Criteria:
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
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
One group study
Gender
Parameters will be measured include gender preoperatively
Time frame: One week for preoperative assessment.
Body weight
Parameters will be measured include body weight in kilograms preoperatively
Time frame: One week for preoperative assessment.
Height
Parameters will be measured include height in meters preoperatively
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: One week for preoperative assessment.
Age
Parameters will be measured include age in months preoperatively
Time frame: One week for preoperative assessment
Gender
Parameters will be measured include gender pre-discharge postoperative assessment.
Time frame: Pre-discharge postoperative assessment within one month
Body weight
Parameters will be measured include body weight in kilograms pre-discharge postoperative assessment.
Time frame: Pre-discharge postoperative assessment within one month
Height
Parameters will be measured include height in meters pre-discharge postoperative assessment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-discharge postoperative assessment within one month
ICU stay
Parameters will be measured include ICU stay days pre-discharge postoperative assessment.
Time frame: 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.
Time frame: Pre-discharge postoperative assessment within one month
Age
Parameters will be measured include age in months pre-discharge postoperative assessment.
Time frame: Pre-discharge postoperative assessment within one month
Gender
Parameters will be measured include gender in follow up after 6 months.
Time frame: Reassessment after 6 months.
Body weight
Parameters will be measured include body weight in kilograms in follow up after 6 months.
Time frame: Reassessment after 6 months.
Height
Parameters will be measured include body height in meters in follow up after 6 months.
Time frame: Reassessment after 6 months.
Oxygen saturation , RV function
Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % in follow up after 6 months.
Time frame: Reassessment after 6 months.
include median RVOT gradient and degree of PV stenosis
Parameters will be measured include include median RVOT gradient in mmhg and degree of PV stenosis by peak gradient across the PV in mmhg in follow up after 6 months.
Time frame: Reassessment after 6 months.
PV annulus and PV z-score
Parameters will be measured include median PV annulus diameter in mm , median PV Z-score diameter in mm in follow up after 6 months.
Time frame: Reassessment after 6 months.
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\^ ) in follow up after 6 months.
Time frame: Reassessment after 6 months.
Age
Parameters will be measured include age in months in follow up after 6 months.
Time frame: Reassessment after 6 months.
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Assiut University