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.: PACTR202001791914614 Date of Approval: 06/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The use of an Autologous Platelet-rich Fibrin membrane in Urethroplasty for cases of Distal Hypospadias: A Randomized Controlled Trial
Official scientific title The use of an Autologous Platelet-rich Fibrin membrane in Urethroplasty for cases of Distal Hypospadias: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial A prospective randomized control study is to evaluate the use of this autologous membrane in improving the healing power and minimizing the incidence of fistula in de novo cases of distal hypospadias
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Hypospadias
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/04/2017
Actual trial start date 01/06/2017
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 01/03/2020
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Platelet rich fibrin During Surgery To evaluate the effect of adding PRF as an additional layer in repair of the cases of distal hypospadias in reducing the incidence of urethrocutaneous fistula after TIP repair. 40
Control Group No PRP During Surgery Control group 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Distal hypospadias Other types of Hypospadias Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 1 Year(s) 10 Year(s) Male
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 01/01/2017 Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy Faculty of Medicine Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Urethrocutaneous fistula after TIP repair 6 months after repair
Secondary Outcome Other complications post repair 6 months after repair
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Pediatric Hospital 1 Ali Ibrahim Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Cairo University Kasr Al Ainy Faculty of Medicine Cairo University Cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Cairo University 1 Ali Ibrahim Street Cairo 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hesham El Saket helsaket@gmail.com 201003204457 1 Ali Ibrahim Street
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Pediatric Surgery
Role Name Email Phone Street address
Public Enquiries Mahmoud Elfiky mfiky@kasralainy.edu.eg 201001557755 1 Ali Ibrahim Street
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Associate Professor of Pediatric Surgery
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Elfiky mfiky@kasralainy.edu.eg 201001557755 1 Ali Ibrahim Street
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Associate Professor of Pediatric Surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes This will be shared via URL to the published study results within 12 months of finishing the data analysis and the study Clinical Study Report,Statistical Analysis Plan,Study Protocol within 12 months of finishing the data analysis and the study URL sharing
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