Early Versus Delayed Closure of Bladder Exstrophy in Female Patients

Eligible phenotypic female neonates who presented with classic bladder exstrophy withinthe first 48 hours of life and met the prespecified clinical and anaesthetic criteriawere enrolled through consecutive sampling. After written consent and baselineassessment, participants were randomized in a 1:1 ratio using a computer‐generatedsequence with randomly varying block sizes and stratification by centre. Allocation wasimplemented through sequentially numbered sealed envelopes prepared independently ofrecruitment.Participants assigned to early closure underwent primary single‐stage repair within 72hours of birth. Participants assigned to delayed closure underwent the same repair at 6to 12 weeks of age. Before delayed surgery, the exposed bladder plate was cleaned withsterile saline and covered with a clear non‐adherent pad, while hydration and weight gainwere monitored. The operation included closure of the bladder and posterior urethra andreconstruction of the lower abdominal wall, pelvic floor, and female external genitalia.Pelvic osteotomy was reserved for predefined anatomical findings or excessive closuretension. Perioperative care was standardized in both groups.Participants were assessed on postoperative days 7, 14, and 30. Successful bladderclosure on postoperative day 30 required an intact deep bladder and abdominal‐wallclosure without full‐thickness wound dehiscence, urinary fistula, or urinary leakagerequiring 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‐treatprinciple.