Comparison of Mid-term Results of Total Correction of Tetralogy of Fallot Between Preservation of Pulmonary Valve and Trans-annular Patching
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- PV annulus and PV z-score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective total correction of tetralogy of Fallot.
- •Any age group.
- •Normal pulmonay branches
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: TOF repair with trans-annular patch VS preservation of PV (Procedure)
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.
干预措施: TOF repair with trans-annular patch VS preservation of PV (Procedure)
结局指标
主要结局
PV annulus and PV z-score
时间窗: One week for preoperative assessment.
Parameters will be measured include median PV annulus diameter in mm , median PV Z-score diameter in mm preoperatively
degree of PV regurge, degree of TR and RV size
时间窗: One week for preoperative assessment.
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
Age
时间窗: One week for preoperative assessment
Parameters will be measured include age in months preoperatively
Body weight
时间窗: One week for preoperative assessment.
Parameters will be measured include body weight in kilograms preoperatively
Height
时间窗: One week for preoperative assessment.
Parameters will be measured include height in meters preoperatively
Oxygen saturation , RV function
时间窗: One week for preoperative assessment.
Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % preoperatively
Gender
时间窗: One week for preoperative assessment.
Parameters will be measured include gender preoperatively
include median RVOT gradient and degree of PV stenosis
时间窗: One week for preoperative assessment.
Parameters will be measured include median RVOT gradient in mmhg , degree of PV stenosis by peak gradient across the PV in mmhg preoperatively
次要结局
- Time till weaning from mechanical ventilator(Pre-discharge postoperative assessment within one month)
- Gender(Pre-discharge postoperative assessment within one month)
- Height(Pre-discharge postoperative assessment within one month)
- Body weight(Pre-discharge postoperative assessment within one month)
- Median cross clamp time and CPB time(Pre-discharge postoperative assessment within one month)
- Oxygen saturation , RV function(Pre-discharge postoperative assessment within one month)
- degree of PV regurge, degree of TR and RV size(Pre-discharge postoperative assessment within one month)
- ICU stay(Pre-discharge postoperative assessment within one month)
- Median RVOT gradient and degree of PV stenosis(Pre-discharge postoperative assessment within one month)
- Age(Pre-discharge postoperative assessment within one month)
- PV annulus and PV z-score(Pre-discharge postoperative assessment within one month)
研究者
Shareef aldesoky shareef
Professor
Assiut University