Bladder Exstrophy
Conditions
Keywords
Classic Bladder Exstrophy, Primary Bladder Closure, Single-Stage Repair, Early Closure, Delayed Closure, Female Neonates, Wound Dehiscence
Brief 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.
Detailed description
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.
Interventions
PROCEDUREEarly 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.
PROCEDUREDelayed 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.
Sponsors
Khyber Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were assigned in a 1:1 ratio to primary single-stage closure within 72 hours of birth or at 6 to 12 weeks of age.
Eligibility
Sex/Gender
FEMALE
Age
0 Days to 2 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Bladder Closure at Postoperative Day 30 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Dehiscence Within 30 Days | From surgery through postoperative day 30 | Number and percentage of participants with partial or complete, superficial or deep disruption of the operative wound within 30 days after surgery. |
| Surgical-Site Infection Within 30 Days | From surgery through postoperative day 30 | 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. |
| Urinary Fistula Within 30 Days | From surgery through postoperative day 30 | 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. |
| Blood Transfusion | From the start of surgery through hospital discharge, up to 30 days after surgery | Number and percentage of participants who received a blood transfusion during the operative or perioperative period. |
| Reoperation Within 30 Days | From surgery through postoperative day 30 | Number and percentage of participants who underwent a repeat surgical procedure related to the primary closure within 30 days after surgery. |
| Readmission Within 30 Days | From discharge through postoperative day 30 | Number and percentage of participants readmitted to hospital within 30 days after surgery. |
| Hospital Stay | From surgery to hospital discharge, up to 30 days after surgery | Duration of the index postoperative hospital stay, measured in days from surgery to discharge. |
| Any Adverse Event Within 30 Days | From surgery through postoperative day 30 | Number and percentage of participants with at least one recorded adverse event within 30 days after surgery. |
Countries
Pakistan
Outcome results
None listed