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

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

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.

Study Overview

• Status: Unknown
• Conditions: Tetrology of Fallot
• Intervention / Treatment: Procedure: TOF repair with trans-annular patch VS preservation of PV

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender	Parameters will be measured include gender in follow up after 6 months.	Reassessment after 6 months.
Body weight	Parameters will be measured include body weight in kilograms in follow up after 6 months.	Reassessment after 6 months.
Height	Parameters will be measured include body height in meters in follow up after 6 months.	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.	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.	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.	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.	Reassessment after 6 months.
Age	Parameters will be measured include age in months in follow up after 6 months.	Reassessment after 6 months.

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Ahmed M. El-Minshawy, Prof, Assiut University; Study Director: Mahmoud Kh Abdelatif, Ass.lecturer, Assiut University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Tetralogy of Fallot
• Other Study ID Numbers: TOF repair

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No