Can surgery within 72 hours of birth improve bladder closure in girls?
NCT ID NCT07794540
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This trial tests whether performing surgery within 72 hours of birth improves outcomes for female newborns with bladder exstrophy, a rare birth defect where the bladder develops outside the body. Half the participants receive surgery within 72 hours, while the other half wait until 6 to 12 weeks of age. Both groups undergo the same repair procedure. The main goal is to see which timing leads to successful bladder and abdominal wall closure 30 days after surgery, while also tracking complications like infection, wound breakdown, and the need for repeat operations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Early primary single-stage closure (surgery within 72 hours of birth) versus delayed primary single-stage closure (surgery at 6-12 weeks of age)
- What this could lead to
- If early surgery works better, it could set a new standard for treating bladder exstrophy in female newborns, improving long-term bladder function and quality of life.
- What could go wrong
- This is a single-center trial, and results may not apply everywhere. Surgery in newborns carries risks like infection, wound breakdown, or need for repeat surgery.
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
-
124 people
The number who actually took part.
- Started
-
Jan 2021
- Finished
-
Mar 2026
- Lead sponsor
-
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
-
0 to 2 days
- Sex
-
Female participants only
- Healthy volunteers
-
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: * Phenotypic female neonates presenting with classic bladder exstrophy within the first 48 hours of life * Met the protocol-defined minimum birth-weight requirement * Gestational age of at least 34 weeks * Clinically stable and fit for general anaesthesia * Written informed consent provided by a parent or legal guardian Exclusion Criteria: * Cloacal exstrophy, an exstrophy variant, or isolated epispadias * Previous bladder or abdominal-wall surgery * Life-threatening congenital anomaly * Uncontrolled sepsis * Coagulopathy * Cardiorespiratory instability precluding surgery within the assigned window * Parent or legal guardian unable or unwilling to comply with follow-up
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bladder exstrophy are added.
By submitting, you agree to our Terms of use
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
-
Khyber Teaching Hospital
Peshawar, Khyber Pakhtunkhwa, Pakistan
More trials for these conditions
Other studies related to the condition(s) this trial covers.