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Trial registered on ANZCTR


Registration number
ACTRN12625000915459
Ethics application status
Approved
Date submitted
15/05/2025
Date registered
22/08/2025
Date last updated
22/08/2025
Date data sharing statement initially provided
22/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of complications of distal hypospadias repair with and without the use of postoperative prophylactic intravenous antibiotics: A randomized controlled trial
Scientific title
Comparison of complications of distal hypospadias repair with and without the use of postoperative prophylactic intravenous antibiotics: A randomized controlled trial
Secondary ID [1] 314452 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distal Hypospadias 337490 0
Condition category
Condition code
Surgery 333855 333855 0 0
Other surgery
Renal and Urogenital 334559 334559 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this group, postoperative intravenous prophylactic antibiotics will NOT be given. Only 1 dose of preoperative intravenous antibiotics is given before the incision is made; that is, an injection of ceftriaxone, given according to the weight of the patient (50 mg/kg) by the anaesthesia team.
Intervention code [1] 331073 0
Treatment: Drugs
Comparator / control treatment
In this group, postoperative prophylactic intravenous antibiotics will be given as per routine. That is, ceftriaxone (50 mg/kg once daily) and amikacin (7.5 mg/kg twice daily) by the staff nurse on duty.
Control group
Active

Outcomes
Primary outcome [1] 341474 0
Wound infection
Timepoint [1] 341474 0
baseline, day 15, and day 30 post surgery
Secondary outcome [1] 447692 0
Complications, e.g., UTI, wound infection, fistula formation, etc.
Timepoint [1] 447692 0
baseline, day 15, and day 30 post surgery

Eligibility
Key inclusion criteria
Patients of male gender.
Patients age up to 12 years.
Patients with distal hypospadias
Minimum age
1 Years
Maximum age
12 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with comorbidities (Malnutrition, Tuberculosis (TB), Liver diseases)
Patients undergoing redo urethroplasty.
Patients lost to follow-up.

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)
central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2024
Date of last participant enrolment
Anticipated
Actual
31/03/2025
Date of last data collection
Anticipated
Actual
30/04/2025
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 27066 0
Pakistan
State/province [1] 27066 0
Punjab

Funding & Sponsors
Funding source category [1] 318990 0
Hospital
Name [1] 318990 0
Mayo Hospital Lahore
Country [1] 318990 0
Pakistan
Primary sponsor type
Hospital
Name
Mayo Hospital Lahore
Address
Country
Pakistan
Secondary sponsor category [1] 321455 0
None
Name [1] 321455 0
Address [1] 321455 0
Country [1] 321455 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317594 0
Institutional Review Board, KEMU
Ethics committee address [1] 317594 0
Ethics committee country [1] 317594 0
Pakistan
Date submitted for ethics approval [1] 317594 0
16/08/2024
Approval date [1] 317594 0
19/09/2024
Ethics approval number [1] 317594 0
581/RC/KEMU

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

Contacts
Principal investigator
Name 141526 0
Dr Muhammad Rehman Waheed
Address 141526 0
Department of Pediatric Surgery, King Edward Medical University, Nelagumbad, Anarkali, Lahore, Pakistan. 54000
Country 141526 0
Pakistan
Phone 141526 0
+923227648950
Fax 141526 0
Email 141526 0
[email protected]
Contact person for public queries
Name 141527 0
Muhammad Rehman Waheed
Address 141527 0
Department of Pediatric Surgery, King Edward Medical University, Nelagumbad, Anarkali, Lahore, Pakistan. 54000
Country 141527 0
Pakistan
Phone 141527 0
+923227648950
Fax 141527 0
Email 141527 0
[email protected]
Contact person for scientific queries
Name 141528 0
Muhammad Rehman Waheed
Address 141528 0
Department of Pediatric Surgery, King Edward Medical University, Nelagumbad, Anarkali, Lahore, Pakistan. 54000
Country 141528 0
Pakistan
Phone 141528 0
+923227648950
Fax 141528 0
Email 141528 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Ethical (Hypospadias).pdf


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.