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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tetrology of Fallot

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    October 22, 2018
    Last Updated
    November 5, 2018
    Sponsor
    Assiut University
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    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

    Learn more about this trial

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

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