Comparison of Mid-term Results of Total Correction of TOF Between Preservation of PV and Trans-annular Patch.
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedFirst Posted
Study publicly available on registry
November 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedNovember 7, 2018
November 1, 2018
9 months
October 22, 2018
November 5, 2018
Conditions
Outcome Measures
Primary Outcomes (8)
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 Outcomes (11)
Gender
Pre-discharge postoperative assessment within one month
Body weight
Pre-discharge postoperative assessment within one month
Height
Pre-discharge postoperative assessment within one month
Oxygen saturation , RV function
Pre-discharge postoperative assessment within one month
Median RVOT gradient and degree of PV stenosis
Pre-discharge postoperative assessment within one month
- +6 more secondary outcomes
Other Outcomes (8)
Gender
Reassessment after 6 months.
Body weight
Reassessment after 6 months.
Height
Reassessment after 6 months.
- +5 more other outcomes
Study Arms (2)
TOF repair with preservation of PV
EXPERIMENTALSurgical intervention by repair of Tetralogy of Fallot with preservation of pulmonary valve, recently interested has shifted to preserving the integrity of the pulmonary valve.
TOF repair with trans-annular patch
EXPERIMENTALSurgical 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.
Interventions
One group study
Eligibility Criteria
You may qualify if:
- Patients undergoing elective total correction of tetralogy of Fallot.
- Any age group.
- Normal pulmonay branches
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 30298850BACKGROUNDVida 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.
PMID: 25983249BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ahmed M. El-Minshawy, Prof
Assiut University
- STUDY DIRECTOR
Mahmoud Kh Abdelatif, Ass.lecturer
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 22, 2018
First Posted
November 7, 2018
Study Start
November 1, 2018
Primary Completion
August 1, 2019
Study Completion
September 1, 2019
Last Updated
November 7, 2018
Record last verified: 2018-11