| CTRI Number |
CTRI/2017/08/009355 [Registered on: 11/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
10/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare two methods of performing heart surgery in blue babies. |
|
Scientific Title of Study
|
Comparison of right ventricular function between trans right atrial versus trans right right atrial/right ventricular approach for Tetralogy of Fallot repair |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sachin Talwar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept of CTVS, CN Center, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9212435564 |
| Fax |
011-26588641 |
| Email |
sachintalwar@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sachin Talwar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept of CTVS, CN Center, AIIMS, New Delhi
DELHI
110029
India |
| Phone |
9212435564 |
| Fax |
011-26588641 |
| Email |
sachintalwar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Anand |
| Designation |
Senior Resident |
| Affiliation |
AIIMS |
| Address |
Dept of CTVS, CN Center, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9868204407 |
| Fax |
|
| Email |
dranandabhishek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Director, All India Institute of Medical Science, New Delhi-110029, India |
|
|
Primary Sponsor
|
| Name |
The Director of AIIMS |
| Address |
Administartive Block, Director Office, All India Institute of Medical Sciences, New Delhi, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SACHIN TALWAR |
AIIMS NEW DELHI |
CTVS OT, First Floor Department of CTVS, AIIMS, New Delhi-110029, India
New Delhi
DELHI |
9868398136
sachintalwar@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients who undergo surgery for Tetralogy of Fallot, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIl |
Nil |
| Intervention |
Trans Right Atrial and Right Ventricular Approach |
Those Tetralogy of Fallot patients who underwent repair by combined trans right atrial and right ventricular approach |
| Intervention |
Trans Right Atrial Approach |
Those tetralogy of Fallot patients who underwent repair by trans right atrial approach |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Those eligible for intracardiac repair of Tetralogy of Fallot |
|
| ExclusionCriteria |
| Details |
Children undergoing trans annular patch or concomitant pulmonary artery procedures, emergency surgery or parents who do not consent for participation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Right Ventricular Function using TAPSE
|
Before operation
Every one day
After 30 days post op
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Death
ICU stay
Post op rythm
Ionotropic score
Duration of Mechanical ventilation
Need for diurectics
Post op Effusion/Chest tube drainage
Hepatomegaly |
Day 1
Days 3, 5, 7, 30
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2015 |
| Date of Study Completion (India) |
30/06/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/06/2016 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Comparison
of right ventricular function between trans right atrial versus trans right
atrial/right ventricular approach for Tetralogy of Fallot repair The approach for surgery for Tetralogy of Fallot has evolved from purely
trans right ventricular approach to purely trans right atrial approach. Trans right atrial/right ventricular approach
had been the choice for majority of cardiothoracic surgeons wherein the right
atrial was used to close to the ventricular septal defect and right
ventriculotomy was used for resection of infundibulum. The trans RA/RV approach
is said to be inferior to the Trans RA approach with respect to incidence of
post-operative arrhythmias, right ventricular dysfunction and sudden death. The
right atrial approach has a long learning curve and has been known to leave
behind residual right ventricular tract obstruction. This study aims to compare
outcome of the trans-right atrial versus trans right atrial/right ventricular
approaches vis-Ã -vis their effect on right ventricular function. |