Clinical trial NCT03732742: Comparison of Mid-term Results of Total Correction of TOF Between Preservation of PV and Trans-annular Patch.
Official title: Comparison of Mid-term Results of Total Correction of Tetralogy of Fallot Between Preservation of Pulmonary Valve and Trans-annular Patching
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tetrology of Fallot
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gender
timeFrame: One week for preoperative assessment.
measure: Body weight
timeFrame: One week for preoperative assessment.
measure: Height
timeFrame: One week for preoperative assessment.
measure: Oxygen saturation , RV function
timeFrame: One week for preoperative assessment.
measure: include median RVOT gradient and degree of PV stenosis
timeFrame: One week for preoperative assessment.
measure: PV annulus and PV z-score
timeFrame: One week for preoperative assessment.
measure: degree of PV regurge, degree of TR and RV size
timeFrame: One week for preoperative assessment.
measure: Age
timeFrame: One week for preoperative assessment
Secondary outcomes:
measure: Gender
timeFrame: Pre-discharge postoperative assessment within one month
measure: Body weight
timeFrame: Pre-discharge postoperative assessment within one month
measure: Height
timeFrame: Pre-discharge postoperative assessment within one month
measure: Oxygen saturation , RV function
timeFrame: Pre-discharge postoperative assessment within one month
measure: Median RVOT gradient and degree of PV stenosis
timeFrame: Pre-discharge postoperative assessment within one month
measure: PV annulus and PV z-score
timeFrame: Pre-discharge postoperative assessment within one month
measure: degree of PV regurge, degree of TR and RV size
timeFrame: Pre-discharge postoperative assessment within one month
measure: Median cross clamp time and CPB time
timeFrame: Pre-discharge postoperative assessment within one month
measure: ICU stay
timeFrame: Pre-discharge postoperative assessment within one month
measure: Time till weaning from mechanical ventilator
timeFrame: Pre-discharge postoperative assessment within one month
measure: Age
timeFrame: Pre-discharge postoperative assessment within one month
Other outcomes:
measure: Gender
timeFrame: Reassessment after 6 months.
measure: Body weight
timeFrame: Reassessment after 6 months.
measure: Height
timeFrame: Reassessment after 6 months.
measure: Oxygen saturation , RV function
timeFrame: Reassessment after 6 months.
measure: include median RVOT gradient and degree of PV stenosis
timeFrame: Reassessment after 6 months.
measure: PV annulus and PV z-score
timeFrame: Reassessment after 6 months.
measure: degree of PV regurge, degree of TR and RV size
timeFrame: Reassessment after 6 months.
measure: Age
timeFrame: Reassessment after 6 months.
Locations:
Study officials:
affiliation: Assiut University
name: Ahmed M. El-Minshawy, Prof
role: STUDY_CHAIR
affiliation: Assiut University
name: Mahmoud Kh Abdelatif, Ass.lecturer
role: STUDY_DIRECTOR
References:
citation: Kwak JG, Kim WH, Kim ER, Lim JH, Min J. One-Year Follow-up After Tetralogy of Fallot Total Repair Preserving Pulmonary Valve and Avoiding Right Ventriculotomy. Circ J. 2018 Nov 24;82(12):3064-3068. doi: 10.1253/circj.CJ-18-0690. Epub 2018 Oct 5.
citation: Vida VL, Angelini A, Guariento A, Frescura C, Fedrigo M, Padalino M, Sanders SP, Thiene G, Stellin G. Preserving the pulmonary valve during early repair of tetralogy of Fallot: Anatomic substrates and surgical strategies. J Thorac Cardiovasc Surg. 2015 May;149(5):1358-63.e1. doi: 10.1016/j.jtcvs.2015.01.030. Epub 2015 Jan 21.