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.: PACTR202211757905870 Date of Registration: 29/11/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Modified meatal advancement and glanuloplasty
Official scientific title Modified meatal advancement and glanuloplasty versus tubularized incised plate urethroplasty for distal hypospadias repair: A prospective randomized study
Brief summary describing the background and objectives of the trial About one in every 300 male births has hypospadias, and the meatus is located distally in approximately 65% of cases. Hypospadias is defined as a maldevelopment of the urethral fold and ventral foreskin, with or without the penile curvature. Any recent classification must include the urethral meatus site, prepuce (complete or incomplete), urethral plate width, glans (flat, cleft, or incomplete cleft), and other associated anomalies if present. This prospective study aims to compare TIP and modified MAGPI techniques for distal hypospadias repair in terms of feasibility, duration of operation, efficacy, and complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 20/04/2022
Actual trial start date 20/04/2022
Anticipated date of last follow up 31/10/2022
Actual Last follow-up date 31/10/2022
Anticipated target sample size (number of participants) 57
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
1323 the local ethics committee of the Quality Education Assurance Unit, Al-Azhar Faculty of Medicine, Nasr City, Cairo, Egypt
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Modified meatal advancement and glanuloplasty all patients done at al azhar univeristy hospitals follow up for at least 2 months In the modified MAGPI technique, we performed a meticulous periurethral dissection down to the corpora cavernosa in both sides using a magnifying Loupe (3.5×) and fine instruments (about 1–1.5 cm). The urethra was then separated from the corpora cavernosa until an appropriate length of the urethra was achieved to reach the tip of the glans without tension. Then, glans wings were developed, and urethral advancement was done. The urethra was fixated in the new site using 6/0 polydioxanone suture (PDS) suture (Fig. 2). The glans was closed using interrupted mattress sutures with 6/0 Vicryl. Then, the tourniquet was released. After skin closure, excess foreskin was removed, and circumcision was performed. A tight dressing was placed for 24 h postoperatively, and a traction suture was used to fix the catheter to the dorsal surface away from the suture line. 25
Control Group tubularized incised plate urethroplasty done all cases was followed for at least 2 months after operation TIP urethroplasty was performed using the classic technique described by Snodgrass [9]. A 1- to 2-mm incision was made proximal to the meatus, and two parallel longitudinal incisions along the urethral plate were made. Then, glandular wings were developed, and a midline incision of the plate was made down to the underlying corpora from the meatus up to the tip of the glans. Then, tubularization was done using 6/0 PDS suture around the catheter. A loose vascularized dartos flap from the prepuce and/or the shaft was used as a second layer to cover the neourethra. Then, closure of the glans and skin and dressing were performed as described previously 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with primary distal hypospadias. 1-Presence of chordee. 2-Proximal hypospadias. 3-Recurrent cases of hypospadias Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 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
Yes 20/04/2022 FMG IRB
Ethics Committee Address
Street address City Postal code Country
Nasr City cairo 11765 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Our modification is feasible and effective and will decrease the incidence of complications after follow up of all cases for at least 2 months
Secondary Outcome modified MAGPI and TIP urethroplasty have comparable short-term outcomes; however, TIP urethroplasty has a lower incidence of postoperative complications. Modified MAGPI is preferred in certain conditions, especially in circumcised child or those with a narrow urethral plate. Further studies with a larger sample size are needed to confirm our findings and identify the preferable technique in those cases. 2 months post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Zahraa University Hospital The Greek Hospital street, Sarayat, Abbasiya, cairo 11535 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
principal investigator The Greek Hospital street, Sarayat, Abbasiya cairo 11535 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Basem abdallah fathy mohammed Alferdoos buildings, Nasr City, Building 7 Cairo 11765 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed El Gammal aelgammal36@gmail.com +201000906335 nasr city
City Postal code Country Position/Affiliation
cairo 11765 Egypt lectrurer of urology faculty of medicine al azhar univeristy
Role Name Email Phone Street address
Public Enquiries ahmed alrefaey a7medrefa3y.ash@gmail.com +201149394121 nasr city
City Postal code Country Position/Affiliation
cairo 11765 Egypt lectrurer of urology al azhar univeristy
Role Name Email Phone Street address
Scientific Enquiries basem fathi dr.basemhara@hotmail.com +201004868961 nasr city
City Postal code Country Position/Affiliation
cairo 11765 Egypt lectrurer of urology al azhar univeristy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The dataset of the current study is available from the corresponding author upon reasonable request. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months available from the corresponding author upon reasonable request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
sending email 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