New study tests better way to fix a common birth defect in boys
NCT ID NCT07525570
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compared two surgical methods for repairing distal hypospadias, a birth defect where the urinary opening is on the underside of the penis. 120 boys aged 2-12 received either a standard double dartos flap or that plus a Byar's flap. The goal was to see which technique leads to fewer complications like fistulas (abnormal openings). Results were assessed over 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- surgical procedure (double dartos flap with or without Byar's flap)
- What this could lead to
- If successful, this could identify a better surgical method to reduce complications like fistulas in children with hypospadias.
- What could go wrong
- This is a small, completed trial with 120 children. Results may not apply to all cases, and surgical risks like infection or scarring remain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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120 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 12 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Male children aged 2-12 years Diagnosis of primary distal penile hypospadias (glanular, coronal, or subcoronal) No previous surgical repair for hypospadias Fit for general anesthesia as determined by preoperative assessment Written informed consent provided by parents or legal guardians - Exclusion Criteria: Midshaft or proximal hypospadias Severe chordee requiring staged repair Previous penile or hypospadias surgery Associated major genital anomalies Micropenis Bleeding disorders or systemic coagulopathies Unfit for general anesthesia \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Mardan Medical Complex, Department of Pediatric Surgery
Mardan, KPK, 22000, Pakistan
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Other studies related to the condition(s) this trial covers.
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