Tetrology of Fallot
Conditions
Brief summary
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
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.
Interventions
PROCEDURETOF repair with trans-annular patch VS preservation of PV
One group study
Sponsors
Assiut University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| include median RVOT gradient and degree of PV stenosis | 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 |
| Oxygen saturation , RV function | One week for preoperative assessment. | Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % preoperatively |
| Gender | One week for preoperative assessment. | Parameters will be measured include gender preoperatively |
| Height | One week for preoperative assessment. | Parameters will be measured include height in meters preoperatively |
| Body weight | One week for preoperative assessment. | Parameters will be measured include body weight in kilograms preoperatively |
| Age | One week for preoperative assessment | Parameters will be measured include age in months preoperatively |
| degree of PV regurge, degree of TR and RV size | 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 |
| PV annulus and PV z-score | One week for preoperative assessment. | Parameters will be measured include median PV annulus diameter in mm , median PV Z-score diameter in mm preoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU stay | Pre-discharge postoperative assessment within one month | Parameters will be measured include ICU stay days pre-discharge postoperative assessment. |
| Time till weaning from mechanical ventilator | Pre-discharge postoperative assessment within one month | Parameters will be measured include Time till weaning from mechanical ventilator in hours pre-discharge postoperative assessment. |
| Age | Pre-discharge postoperative assessment within one month | Parameters will be measured include age in months pre-discharge postoperative assessment. |
| Median RVOT gradient and degree of PV stenosis | Pre-discharge postoperative assessment within one month | 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. |
| PV annulus and PV z-score | Pre-discharge postoperative assessment within one month | Parameters will be measured include median PV annulus diameter in mm , median PV Z-score diameter in mm pre-discharge postoperative assessment. |
| Gender | Pre-discharge postoperative assessment within one month | Parameters will be measured include gender pre-discharge postoperative assessment. |
| Body weight | Pre-discharge postoperative assessment within one month | Parameters will be measured include body weight in kilograms pre-discharge postoperative assessment. |
| Height | Pre-discharge postoperative assessment within one month | Parameters will be measured include height in meters pre-discharge postoperative assessment. |
| Oxygen saturation , RV function | Pre-discharge postoperative assessment within one month | Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % Pre-discharge postoperative assessment. |
| degree of PV regurge, degree of TR and RV size | Pre-discharge postoperative assessment within one month | 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. |
| Median cross clamp time and CPB time | Pre-discharge postoperative assessment within one month | Parameters will be measured include Median cross clamp time in minutes and CPB time in minutes pre-discharge postoperative assessment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gender | Reassessment after 6 months. | Parameters will be measured include gender in follow up after 6 months. |
| Age | Reassessment after 6 months. | Parameters will be measured include age in months in follow up after 6 months. |
| degree of PV regurge, degree of TR and RV size | Reassessment after 6 months. | 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. |
| PV annulus and PV z-score | Reassessment after 6 months. | Parameters will be measured include median PV annulus diameter in mm , median PV Z-score diameter in mm in follow up after 6 months. |
| include median RVOT gradient and degree of PV stenosis | Reassessment after 6 months. | 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. |
| Oxygen saturation , RV function | Reassessment after 6 months. | Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % in follow up after 6 months. |
| Height | Reassessment after 6 months. | Parameters will be measured include body height in meters in follow up after 6 months. |
| Body weight | Reassessment after 6 months. | Parameters will be measured include body weight in kilograms in follow up after 6 months. |
Contacts
Primary ContactShareef Al Shareef, Master
Backup ContactHussein K El khayat, Lecturer
Outcome results
None listed