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Randomized Trial Of Urethroplasty With Stent Versus Without Stent For Hypospadias

NCT07243457 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-11-21

No results posted yet for this study

Summary

Hypospadias is a birth condition in which the urine opening is on the underside of the penis. Surgery (urethroplasty) is the standard treatment. Surgeons sometimes leave a small tube ("stent") inside the new urine passage after surgery, but it is unclear whether using a stent affects the risk of a common complication called a urethrocutaneous fistula (a small leak from the new urethra to the skin).

This study will compare two routine surgical approaches for boys 1-12 years old with distal or mid-penile hypospadias who need urethroplasty: (1) surgery with a temporary stent and (2) surgery without a stent. Children will be randomly assigned to one of the two groups. All surgeries will be performed by a consultant pediatric surgeon using a standardized technique, and all children will receive usual postoperative care.

Families will return for follow-up at 2, 6, and 12 weeks after surgery. At these visits, the team will check for fistula using a simple saline test and record any other concerns. We aim to learn which approach leads to fewer complications, less discomfort, and fewer additional procedures for children undergoing hypospadias repair.

Conditions

  • Hypospadias

Interventions

PROCEDURE

Stent urethroplasty

Urethroplasty with temporary urethral stent (6-8 Fr nasogastric tube) placed intraoperatively and removed on postoperative day 7. Standardized technique: incision after infiltration with 0.5% lignocaine + adrenaline (1:200,000; 5-7 mg/kg), 3-layer repair (PDS 6/0 for first and second layers-interrupted then continuous; Polyglactin 5/0 interrupted for skin). Routine postoperative antibiotics and analgesia. Applies to Arm(s): Stent Urethroplasty (Group A).

PROCEDURE

Stentless urethroplasty

Urethroplasty without urethral stent using the same standardized operative technique and peri-operative care; planned discharge on postoperative day 2. Applies to Arm(s): Stentless Urethroplasty (Group B).

Sponsors & Collaborators

  • Children's Hospital and Institute of Child Health, Multan

    lead OTHER_GOV

Principal Investigators

  • Saira Shafee, MBBS · Children's Hospital and Institute of Child Health, Multan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-25
Primary Completion
2025-09-20
Completion
2025-09-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07243457 on ClinicalTrials.gov