Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202212468447073 Date of Approval: 21/12/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Early and mid-term results of surgical treatment of Atrio-Ventricular Septal Defect; Analysis of risk factors for adverse outcomes
Official scientific title Early and mid-term results of surgical treatment of Atrio-Ventricular Septal Defect; Analysis of risk factors for adverse outcomes
Brief summary describing the background and objectives of the trial The spectrum of atrioventricular septal defects (AVSD) accounts for about 7–17% of congenital heart disease and 25% of them are partial atrioventricular septal defects. VSD represents a congenital malformation in which there is a common junction with a deficiency in the atrioventricular septum, extending various degrees into the atrial and ventricular septum. Due to left-to-right shunting, symptoms of congestive heart failure, and the risk of irreversible changes to the pulmonary vascular endothelium, thus repair of the complete AVSD is necessary and frequently employed in infancy. Alterations in surgical techniques, increased knowledge of the anatomy of the conduction system and improved perioperative care led to improved outcomes after AVSD repair. The aim of this study is to analyze the risk factors predisposing the adverse outcomes in the early and mid-term post-operative follow up after surgical treatment of AVSD.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 20/07/2020
Actual trial start date 23/07/2020
Anticipated date of last follow up 20/12/2022
Actual Last follow-up date 07/01/2023
Anticipated target sample size (number of participants) 77
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group double patch closure of atrioventricular septal defect intraoperative depending on the surgeon's opinion tailored for the patient. Surgical technique was chosen by the surgeon's opinion tailored for the patient. 39 Uncontrolled
Experimental Group modified single patch technique intraoperative decision of surgeon of surgical technique was chosen by the surgeon 38
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 All atrioventricular septal defect patients that have underwent primary surgical biventricular repair.  Post pulmonary artery banding.  PDA -other ASD or PFO.  Down syndrome patients  Associated other conotruncal abnormalities  Syndromes other than Down syndrome.  Preoperative renal affection  Preoperative liver affection  Unbalanced ventricles. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 3 Month(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/08/2020 Research Ethics committee at the faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
38 Abbassia, Next to the Al-Nour Mosque Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Early mortality 30 days post operative
Primary Outcome late mortality beyond 30 days post operative.
Secondary Outcome Left atrioventricular valve regurgitation last follow up echocardiography
Secondary Outcome Residual shunting through ventricular or atrial septum last follow up echocardiography
Secondary Outcome left ventricular outflow obstruction. last follow up echocardiography
Secondary Outcome Reoperation for any reason from the secondary endpoints last follow up visit
Secondary Outcome complete heart block last follow up visit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospital 38 Abbassia Square, Next to Al-Nour Mosque, Cairo, Egypt Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The principal investigator 6A Salah El-Din St Cairo 11659 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain shams university 38 Abbassia, Next to the Al-Nour Mosque Cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mina Ata Gobrran 6A Salah El-Din St Cairo 11659 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mina Ata Gobran Ayoub mina.gobran@med.asu.edu.eg +201273728119 6A Salah El-Din St
City Postal code Country Position/Affiliation
Cairo 11659 Egypt Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Ashraf Abd El Hamid El Midany Ashraf_abdlhamid@med.asu.edu.eg +201006448285 Omarat Al Moltaka, Abbasia squar.
City Postal code Country Position/Affiliation
Cairo 11517 Egypt Professor of cardiothoracic surgery Ain Shams University
Role Name Email Phone Street address
Public Enquiries Mohamed Adel Abd El Fattah mo7amd3adel@yahoo.com +201003642199 Saudia buildings, Hadaek El Koba.
City Postal code Country Position/Affiliation
Cairo 11646 Egypt Lecturer of Cardiothoracic surgery Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data collected during the trial, after deidentification Study Protocol Following publication Any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information