Early Versus Delayed Closure of Bladder Exstrophy in Female Patients

August 28, 2026 updated by: Sajjad Ali, Khyber Teaching Hospital

Primary Single-Stage Early Versus Delayed Closure of Bladder Exstrophy in Female Patients: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Peshawar, Khyber Pakhtunkhwa, Pakistan
        • Khyber Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Closure
Participants underwent primary single-stage closure within 72 hours of birth.
Procedure: Early 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.
Active Comparator: Delayed 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Bladder Closure at Postoperative Day 30
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Dehiscence Within 30 Days
Time Frame: 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.
From surgery through postoperative day 30
Surgical-Site Infection Within 30 Days
Time Frame: 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.
From surgery through postoperative day 30
Urinary Fistula Within 30 Days
Time Frame: 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.
From surgery through postoperative day 30
Blood Transfusion
Time Frame: 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.
From the start of surgery through hospital discharge, up to 30 days after surgery
Reoperation Within 30 Days
Time Frame: 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.
From surgery through postoperative day 30
Readmission Within 30 Days
Time Frame: From discharge through postoperative day 30
Number and percentage of participants readmitted to hospital within 30 days after surgery.
From discharge through postoperative day 30
Hospital Stay
Time Frame: 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.
From surgery to hospital discharge, up to 30 days after surgery
Any Adverse Event Within 30 Days
Time Frame: From surgery through postoperative day 30
Number and percentage of participants with at least one recorded adverse event within 30 days after surgery.
From surgery through postoperative day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khyber Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2021

Primary Completion (Actual)

March 15, 2026

Study Completion (Actual)

March 15, 2026

Study Registration Dates

First Submitted

August 24, 2026

First Submitted That Met QC Criteria

August 28, 2026

First Posted (Actual)

August 31, 2026

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTH-BE-RCT-2021-2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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