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Trial registered on ANZCTR


Registration number
ACTRN12625000177459
Ethics application status
Approved
Date submitted
22/11/2024
Date registered
14/02/2025
Date last updated
14/02/2025
Date data sharing statement initially provided
14/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of transverse mattress vs continuous suture urethroplasty in tubularized incised plate hypospadias repair: a prospective study
Scientific title
Comparison of transverse mattress vs continuous suture urethroplasty in tubularized incised plate hypospadias repair in males aged 1 to 13 years: a prospective study
Secondary ID [1] 313448 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypospadias repair 335846 0
Condition category
Condition code
Surgery 332424 332424 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The operative steps of hypospadias surgery involved penile degloving, correction of chordee and reconstruction of the urethra (urethroplasty).
The technique involved taking sutures from 1 cm on one edge of the urethral plate passing through the soft tissue beneath both urethral edges, and emerging 1cm from the other urethral edge. The suture was then returned to create a transverse mattress suture. Multiple sutures were used to reconstruct the neourethra.
Approximate duration of procedure is 60 to 120 minutes.
Surgeon will be administrating the intervention.
Operation report is used to monitor adherence to the intervention.
Intervention code [1] 330025 0
Treatment: Surgery
Comparator / control treatment
The technique involved reconstructing the neourethra with 5-0 polyglactin(Vicryl) suture in continuous manner (subcuticular ) in single layer over an 8 to 10 F catheter.
Approximate duration of the procedure is 60 to 120 minutes.
Surgeon will be administrating the control.
Operation report is used to monitor adherence to the control.
Control group
Active

Outcomes
Primary outcome [1] 339977 0
urethral fistula
Timepoint [1] 339977 0
1 week after operation
Primary outcome [2] 340231 0
Wound infection and wound dehiscence
Timepoint [2] 340231 0
7 days after operation (after removal of stent)
Secondary outcome [1] 442148 0
adequacy of urinary stream
Timepoint [1] 442148 0
after 1 weeks of procedure
Secondary outcome [2] 443429 0
cosmetic appearance
Timepoint [2] 443429 0
2 weeks after operation

Eligibility
Key inclusion criteria
Only primary cases with sub coronal, distal , mid penile and proximal hypospadias suitable for Snodgrass TIP urethroplasty are included in the study
Minimum age
1 Years
Maximum age
13 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Proximal hypospadias, recurrent hypospadias , moderate to severe chordee are excluded from the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization using a randomization table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Group A : continuous suture technique was used
Group B: transverse mattress suture technique was used
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data will be analyzed using SPSS 26. And a p value of less than 0.05 will be considered statistically significant. Simple frequencies and proportions will be used to describe the demographic and other variables

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/07/2024
Date of last participant enrolment
Anticipated
Actual
1/11/2024
Date of last data collection
Anticipated
Actual
15/11/2024
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 26754 0
Pakistan
State/province [1] 26754 0
Punjab

Funding & Sponsors
Funding source category [1] 317888 0
Self funded/Unfunded
Name [1] 317888 0
Country [1] 317888 0
Primary sponsor type
Individual
Name
Dr Mahwish Noor ul haq, Mayo hospital Lahore
Address
Country
Pakistan
Secondary sponsor category [1] 320229 0
None
Name [1] 320229 0
Address [1] 320229 0
Country [1] 320229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316572 0
Institutional review board king Edward medical university nila gumbad new anar Kali Lahore Pakistan
Ethics committee address [1] 316572 0
Ethics committee country [1] 316572 0
Pakistan
Date submitted for ethics approval [1] 316572 0
31/05/2024
Approval date [1] 316572 0
13/07/2024
Ethics approval number [1] 316572 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138290 0
Ms Dr Mahwish Noor ul haq
Address 138290 0
Mayo hospital , Anarkali bazaar Lahore, Punjab 54000
Country 138290 0
Pakistan
Phone 138290 0
+923045334860
Fax 138290 0
Email 138290 0
mahwishnoor80@gmail.com
Contact person for public queries
Name 138291 0
Dr Mahwish Noor ul haq
Address 138291 0
Mayo hospital, Anarkali bazaar Lahore, Punjab 54000
Country 138291 0
Pakistan
Phone 138291 0
+923045334860
Fax 138291 0
Email 138291 0
mahwishnoor80@gmail.com
Contact person for scientific queries
Name 138292 0
Dr Mahwish Noor ul haq
Address 138292 0
Mayo hospital, Anarkali bazaar Lahore, Punjab 54000
Country 138292 0
Pakistan
Phone 138292 0
+923045334860
Fax 138292 0
Email 138292 0
mahwishnoor80@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24364Study protocol    388808-(Uploaded-22-11-2024-22-34-01)-urethroplasty mattress suture (2).docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.