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Early Versus Delayed Closure of Bladder Exstrophy in Female Patients

28 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

124

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Actieve vergelijker: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Successful Bladder Closure at Postoperative Day 30
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Wound Dehiscence Within 30 Days
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Khyber Teaching Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 januari 2021

Primaire voltooiing (Werkelijk)

15 maart 2026

Studie voltooiing (Werkelijk)

15 maart 2026

Studieregistratiedata

Eerst ingediend

24 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 augustus 2026

Eerst geplaatst (Werkelijk)

31 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

28 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KTH-BE-RCT-2021-2026

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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