An interventional study of Early Primary Single-Stage Closure and Delayed Primary Single-Stage Closure in Bladder Exstrophy, sponsored by Khyber Teaching Hospital. Completed at 1 site in Pakistan. Open to female participants aged 0 Days to 2 Days. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Khyber Teaching Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Participants underwent primary single-stage closure within 72 hours of birth.
Procedure: Early Primary Single-Stage Closure
Participants underwent primary single-stage closure at 6 to 12 weeks of age.
Procedure: Delayed 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.
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.
Successful Bladder Closure at Postoperative Day 30
Number and percentage of participants with an intact deep bladder and abdominal-wall closure without full-thickness abdominal wound dehiscence, urinary fistula, or urinary leakage requiring repeat closure or urinary diversion on or before postoperative day 30.
Time frame: Postoperative day 30
Wound Dehiscence Within 30 Days
Number and percentage of participants with partial or complete, superficial or deep disruption of the operative wound within 30 days after surgery.
Time frame: From surgery through postoperative day 30
Surgical-Site Infection Within 30 Days
Number and percentage of participants with inflammatory signs at the operative site, with or without purulent discharge or positive culture, requiring antibiotic or surgical treatment within 30 days after surgery.
Time frame: From surgery through postoperative day 30
Urinary Fistula Within 30 Days
Number and percentage of participants with continuous urinary leakage from the wound or another site after surgery, confirmed clinically or by imaging and requiring continued drainage or intervention.
Time frame: From surgery through postoperative day 30
Blood Transfusion
Number and percentage of participants who received a blood transfusion during the operative or perioperative period.
Time frame: From the start of surgery through hospital discharge, up to 30 days after surgery
Reoperation Within 30 Days
Number and percentage of participants who underwent a repeat surgical procedure related to the primary closure within 30 days after surgery.
Time frame: From surgery through postoperative day 30
Readmission Within 30 Days
Number and percentage of participants readmitted to hospital within 30 days after surgery.
Time frame: From discharge through postoperative day 30
Hospital Stay
Duration of the index postoperative hospital stay, measured in days from surgery to discharge.
Time frame: From surgery to hospital discharge, up to 30 days after surgery
Any Adverse Event Within 30 Days
Number and percentage of participants with at least one recorded adverse event within 30 days after surgery.
Time frame: From surgery through postoperative day 30
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Bladder Exstrophy
Khyber Teaching Hospital