Early Versus Delayed Closure of Bladder Exstrophy in Female Patients
2026년 8월 28일 업데이트: 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.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (실제)
등록
124
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Khyber Pakhtunkhwa
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Peshawar, Khyber Pakhtunkhwa, 파키스탄
- Khyber Teaching Hospital
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Early Closure
Participants underwent primary single-stage closure within 72 hours of birth.
|
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.
|
|
활성 비교기: Delayed Closure
Participants underwent primary single-stage closure at 6 to 12 weeks of age.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Successful Bladder Closure at Postoperative Day 30
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Wound Dehiscence Within 30 Days
기간: 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
기간: 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
기간: 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.
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From surgery through postoperative day 30
|
|
Blood Transfusion
기간: 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.
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From the start of surgery through hospital discharge, up to 30 days after surgery
|
|
Reoperation Within 30 Days
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2021년 1월 28일
기본 완료 (실제)
기본 완료
2026년 3월 15일
연구 완료 (실제)
연구 완료
2026년 3월 15일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 24일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 28일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 31일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 28일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- KTH-BE-RCT-2021-2026
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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