Early Versus Delayed Closure of Bladder Exstrophy in Female Patients

NCT07794540 | Completed

• 1 other identifier: KTH-BE-RCT-2021-2026
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Exstrophy

Keywords

Classic Bladder Exstrophy; Primary Bladder Closure; Single-Stage Repair; Early Closure; Delayed Closure; Female Neonates; Wound Dehiscence

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative day 30

Secondary Outcomes (8)

• Wound Dehiscence Within 30 Days

  From surgery through postoperative day 30

• Surgical-Site Infection Within 30 Days

  From surgery through postoperative day 30

• Urinary Fistula Within 30 Days

  From surgery through postoperative day 30

• Blood Transfusion

  From the start of surgery through hospital discharge, up to 30 days after surgery

• Reoperation Within 30 Days

  From surgery through postoperative day 30

Study Arms (2)

Early Closure

EXPERIMENTAL

Participants underwent primary single-stage closure within 72 hours of birth.

Procedure: Early Primary Single-Stage Closure

Delayed Closure

ACTIVE COMPARATOR

Participants underwent primary single-stage closure at 6 to 12 weeks of age.

Procedure: Delayed Primary Single-Stage Closure

Interventions

Early Primary Single-Stage Closure PROCEDURE

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.

Early Closure

Delayed Primary Single-Stage Closure PROCEDURE

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.

Delayed Closure

Eligibility Criteria

• Age: 0 Days - 2 Days
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khyber Teaching Hospital: lead

Study Sites (1)

Khyber Teaching Hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Conditions

Bladder Exstrophy

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 31, 2026
• Study Start: January 28, 2021
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: August 31, 2026

Record last verified: 2026-08

Locations

PA (1)