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

November 5, 2018 updated by: Shareef aldesoky shareef, Assiut University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gender
Time Frame: One week for preoperative assessment.
Parameters will be measured include gender preoperatively
One week for preoperative assessment.
Body weight
Time Frame: One week for preoperative assessment.
Parameters will be measured include body weight in kilograms preoperatively
One week for preoperative assessment.
Height
Time Frame: One week for preoperative assessment.
Parameters will be measured include height in meters preoperatively
One week for preoperative assessment.
Oxygen saturation , RV function
Time Frame: One week for preoperative assessment.
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
Time Frame: One week for preoperative assessment.
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
Time Frame: One week for preoperative assessment.
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
Time Frame: One week for preoperative assessment.
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
Time Frame: One week for preoperative assessment
Parameters will be measured include age in months preoperatively
One week for preoperative assessment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gender
Time Frame: Pre-discharge postoperative assessment within one month
Parameters will be measured include gender pre-discharge postoperative assessment.
Pre-discharge postoperative assessment within one month
Body weight
Time Frame: Pre-discharge postoperative assessment within one month
Parameters will be measured include body weight in kilograms pre-discharge postoperative assessment.
Pre-discharge postoperative assessment within one month
Height
Time Frame: Pre-discharge postoperative assessment within one month
Parameters will be measured include height in meters pre-discharge postoperative assessment.
Pre-discharge postoperative assessment within one month
Oxygen saturation , RV function
Time Frame: Pre-discharge postoperative assessment within one month
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
Time Frame: Pre-discharge postoperative assessment within one month
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
Time Frame: Pre-discharge postoperative assessment within one month
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
Time Frame: Pre-discharge postoperative assessment within one month
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
Time Frame: Pre-discharge postoperative assessment within one month
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
Time Frame: Pre-discharge postoperative assessment within one month
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
Time Frame: Pre-discharge postoperative assessment within one month
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
Time Frame: Pre-discharge postoperative assessment within one month
Parameters will be measured include age in months pre-discharge postoperative assessment.
Pre-discharge postoperative assessment within one month

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gender
Time Frame: Reassessment after 6 months.
Parameters will be measured include gender in follow up after 6 months.
Reassessment after 6 months.
Body weight
Time Frame: Reassessment after 6 months.
Parameters will be measured include body weight in kilograms in follow up after 6 months.
Reassessment after 6 months.
Height
Time Frame: Reassessment after 6 months.
Parameters will be measured include body height in meters in follow up after 6 months.
Reassessment after 6 months.
Oxygen saturation , RV function
Time Frame: Reassessment after 6 months.
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
Time Frame: Reassessment after 6 months.
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
Time Frame: Reassessment after 6 months.
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
Time Frame: Reassessment after 6 months.
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
Time Frame: Reassessment after 6 months.
Parameters will be measured include age in months in follow up after 6 months.
Reassessment after 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ahmed M. El-Minshawy, Prof, Assiut University
  • Study Director: Mahmoud Kh Abdelatif, Ass.lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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