Early Versus Delayed Closure of Bladder Exstrophy in Female Patients

Eligible phenotypic female neonates who presented with classic bladder exstrophy within the first 48 hours of life and met the prespecified clinical and anaesthetic criteria were enrolled through consecutive sampling. After written consent and baseline assessment, participants were randomized in a 1:1 ratio using a computer-generated sequence with randomly varying block sizes and stratification by centre. Allocation was implemented through sequentially numbered sealed envelopes prepared independently of recruitment.

Participants assigned to early closure underwent primary single-stage repair within 72 hours of birth. Participants assigned to delayed closure underwent the same repair at 6 to 12 weeks of age. Before delayed surgery, the exposed bladder plate was cleaned with sterile saline and covered with a clear non-adherent pad, while hydration and weight gain were monitored. The operation included closure of the bladder and posterior urethra and reconstruction of the lower abdominal wall, pelvic floor, and female external genitalia. Pelvic osteotomy was reserved for predefined anatomical findings or excessive closure tension. Perioperative care was standardized in both groups.

Participants were assessed on postoperative days 7, 14, and 30. Successful bladder closure on postoperative day 30 required an intact deep bladder and abdominal-wall closure without full-thickness wound dehiscence, urinary fistula, or urinary leakage requiring repeat closure or urinary diversion. Secondary outcomes were wound dehiscence, surgical-site infection, urinary fistula, blood transfusion, reoperation, readmission, hospital stay, and adverse events. The primary analysis followed the intention-to-treat principle.

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