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.: PACTR202201653970562 Date of Approval: 11/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative Study Between Closure of small and medium sized urethrocutaneous fistula after hypospadias repair with and without autologous PRP graft
Official scientific title Comparative Study Between Closure of small and medium sized urethrocutaneous fistula after hypospadias repair with and without autologous PRP graft
Brief summary describing the background and objectives of the trial This is a RCT on patients suffering from urethrocutaneous fistula (UCF)post hypospadis repair in which the total 40 participants will divided in two groups one of them will be treated with PRP gaft and the othe without PRP graft at Alazhar university hospitals .UCF is the most common complication after hypospadias surgeries and PRP by having groth factors and clotting factors will help in wound healing and better outcomes of hypospadis surgeries
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2022
Actual trial start date 08/01/2022
Anticipated date of last follow up 04/02/2023
Actual Last follow-up date 30/04/2023
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Closed to recruitment,follow-up continuing
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Prp graft applicatiin over repair Once Permenet Prp application after repair of post hypospadias repair distula 20
Control Group repair of fistula primary repair of fistula 60 mins repair of fistula with vicryl 6/0 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Fresh fistula Small fistula Medium sized fistula Recurrent fistula Crippled hypospadias Blood disease Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 1 Year(s) 12 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
No 31/01/2022 Alazhar faculty of medicine assuit
Ethics Committee Address
Street address City Postal code Country
Faisal Assuit 71524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Recurrence of fistula within 6 months
Secondary Outcome other complications within 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alazhar university hospitals Bab alsheeria ,alhussin Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alazhar Faculty of medicine assuit Faisal Assuit 1775 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor alazhar university hospitals assuit assuit Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Moussa Drmed5057@yahoo.com 01012122105 cairo,egypt
City Postal code Country Position/Affiliation
cairo Egypt Lecturer of Pediatric Surgery
Role Name Email Phone Street address
Public Enquiries Ahmed Abdelfatah Elshamy Drahmedelshamy@gmail.com 01012122105 cairo,egypt
City Postal code Country Position/Affiliation
cairo Egypt Associate Professor of Pediatric Surgery
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Moussa Drmed5057@yahoo.com 01012122105 bab alsharia st
City Postal code Country Position/Affiliation
cairo Egypt MD Lecturer of Pediatric Surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available the primary outcome is recurrent fistula formation noticed by drippling of urine through defect and other results and complications will be reported Clinical Study Report,Informed Consent Form,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