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Early Versus Delayed Closure of Bladder Exstrophy in Female Patients
Sponsor: Khyber Teaching Hospital
Summary
This study compared two timings for primary single-stage surgery in female newborns with classic bladder exstrophy. Participants were randomly assigned to surgery within 72 hours of birth or at 6 to 12 weeks of age. Both groups received the same surgical repair and standardized perioperative care. The main outcome was successful closure of the bladder and abdominal wall 30 days after surgery. The study also evaluated wound dehiscence, surgical-site infection, urinary fistula, blood transfusion, reoperation, readmission, hospital stay, and adverse events.
Official title: Primary Single-Stage Early Versus Delayed Closure of Bladder Exstrophy in Female Patients: A Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
0 Days - 2 Days
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2021-01-28
Completion Date
2026-03-15
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
Early Primary Single-Stage Closure
Primary single-stage closure performed within 72 hours of birth. The procedure included closure of the bladder and posterior urethra and reconstruction of the lower abdominal wall, pelvic floor, and female external genitalia during one anaesthetic. Pelvic osteotomy was reserved for predefined anatomical findings or excessive closure tension.
Delayed Primary Single-Stage Closure
Primary single-stage closure performed at 6 to 12 weeks of age using the same operative checklist and repair. Before surgery, the exposed bladder plate was cleaned with sterile saline and covered with a clear non-adherent pad, with monitoring of hydration and weight gain. Pelvic osteotomy was reserved for predefined anatomical findings or excessive closure tension.
Locations (1)
Khyber Teaching Hospital
Peshawar, Khyber Pakhtunkhwa, Pakistan