Comparison of Mid-term Results of Total Correction of TOF Between Preservation of PV and Trans-annular Patch.
Primary Purpose
Tetrology of Fallot
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TOF repair with trans-annular patch VS preservation of PV
Sponsored by
About this trial
This is an interventional prevention trial for Tetrology of Fallot
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing elective total correction of tetralogy of Fallot.
- Any age group.
- Normal pulmonay branches
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TOF repair with preservation of PV
TOF repair with trans-annular patch
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Gender
Parameters will be measured include gender preoperatively
Body weight
Parameters will be measured include body weight in kilograms preoperatively
Height
Parameters will be measured include height in meters preoperatively
Oxygen saturation , RV function
Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % preoperatively
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
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
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
Age
Parameters will be measured include age in months preoperatively
Secondary Outcome Measures
Gender
Parameters will be measured include gender pre-discharge postoperative assessment.
Body weight
Parameters will be measured include body weight in kilograms pre-discharge postoperative assessment.
Height
Parameters will be measured include height in meters pre-discharge postoperative assessment.
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.
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.
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.
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.
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.
ICU stay
Parameters will be measured include ICU stay days pre-discharge postoperative assessment.
Time till weaning from mechanical ventilator
Parameters will be measured include Time till weaning from mechanical ventilator in hours pre-discharge postoperative assessment.
Age
Parameters will be measured include age in months pre-discharge postoperative assessment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03732742
Brief Title
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
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetrology of Fallot
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TOF repair with preservation of PV
Arm Type
Experimental
Arm Description
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.
Arm Title
TOF repair with trans-annular patch
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
TOF repair with trans-annular patch VS preservation of PV
Intervention Description
One group study
Primary Outcome Measure Information:
Title
Gender
Description
Parameters will be measured include gender preoperatively
Time Frame
One week for preoperative assessment.
Title
Body weight
Description
Parameters will be measured include body weight in kilograms preoperatively
Time Frame
One week for preoperative assessment.
Title
Height
Description
Parameters will be measured include height in meters preoperatively
Time Frame
One week for preoperative assessment.
Title
Oxygen saturation , RV function
Description
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.
Title
include median RVOT gradient and degree of PV stenosis
Description
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.
Title
PV annulus and PV z-score
Description
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.
Title
degree of PV regurge, degree of TR and RV size
Description
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.
Title
Age
Description
Parameters will be measured include age in months preoperatively
Time Frame
One week for preoperative assessment
Secondary Outcome Measure Information:
Title
Gender
Description
Parameters will be measured include gender pre-discharge postoperative assessment.
Time Frame
Pre-discharge postoperative assessment within one month
Title
Body weight
Description
Parameters will be measured include body weight in kilograms pre-discharge postoperative assessment.
Time Frame
Pre-discharge postoperative assessment within one month
Title
Height
Description
Parameters will be measured include height in meters pre-discharge postoperative assessment.
Time Frame
Pre-discharge postoperative assessment within one month
Title
Oxygen saturation , RV function
Description
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
Title
Median RVOT gradient and degree of PV stenosis
Description
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
Title
PV annulus and PV z-score
Description
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
Title
degree of PV regurge, degree of TR and RV size
Description
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
Title
Median cross clamp time and CPB time
Description
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
Title
ICU stay
Description
Parameters will be measured include ICU stay days pre-discharge postoperative assessment.
Time Frame
Pre-discharge postoperative assessment within one month
Title
Time till weaning from mechanical ventilator
Description
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
Title
Age
Description
Parameters will be measured include age in months pre-discharge postoperative assessment.
Time Frame
Pre-discharge postoperative assessment within one month
Other Pre-specified Outcome Measures:
Title
Gender
Description
Parameters will be measured include gender in follow up after 6 months.
Time Frame
Reassessment after 6 months.
Title
Body weight
Description
Parameters will be measured include body weight in kilograms in follow up after 6 months.
Time Frame
Reassessment after 6 months.
Title
Height
Description
Parameters will be measured include body height in meters in follow up after 6 months.
Time Frame
Reassessment after 6 months.
Title
Oxygen saturation , RV function
Description
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.
Title
include median RVOT gradient and degree of PV stenosis
Description
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.
Title
PV annulus and PV z-score
Description
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.
Title
degree of PV regurge, degree of TR and RV size
Description
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.
Title
Age
Description
Parameters will be measured include age in months in follow up after 6 months.
Time Frame
Reassessment after 6 months.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing elective total correction of tetralogy of Fallot.
Any age group.
Normal pulmonay branches
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shareef Al Shareef, Master
Phone
+966533505988
Email
shareefaldesoky12@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hussein K El khayat, Lecturer
Phone
+201005549653
Email
dr_khayat@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M. El-Minshawy, Prof
Organizational Affiliation
Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mahmoud Kh Abdelatif, Ass.lecturer
Organizational Affiliation
Assiut University
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
30298850
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.
Results Reference
background
PubMed Identifier
25983249
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.
Results Reference
background
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Comparison of Mid-term Results of Total Correction of TOF Between Preservation of PV and Trans-annular Patch.
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