Vacuum-Assisted Mini-Percutaneous Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones (VAMPCL-Ped)
Vacuum-Assisted Mini-Percutaneous Cystolithotomy Versus Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Study
연구 개요
상태
상세 설명
Bladder stones in children remain a relevant urological condition, particularly in settings where nutritional, metabolic, infectious, or hydration-related factors may contribute to stone formation. Minimally invasive endoscopic management has largely replaced open cystolithotomy in many centers. Transurethral cystolithotripsy is commonly used, but in young children the small urethral caliber may make repeated instrumentation and fragment extraction technically challenging and may raise concern about urethral mucosal trauma. Percutaneous cystolithotripsy provides an alternative route that may reduce repeated transurethral fragment extraction.
Vacuum-assisted mini-percutaneous cystolithotripsy uses a suprapubic percutaneous access tract and a suction-assisted sheath to maintain visibility and facilitate evacuation of stone dust and fragments during laser lithotripsy. However, pediatric comparative evidence remains limited.
This study is designed as a prospective randomized controlled pilot study including 40 children with bladder stone(s) measuring 10-30 mm. Eligible patients will be randomized in a 1:1 ratio to vacuum-assisted mini-percutaneous cystolithotripsy or transurethral cystolithotripsy. Both procedures will be performed under general anesthesia using Ho:YAG laser lithotripsy. Patients will be followed postoperatively to assess operative, perioperative, and follow-up outcomes. The study aims to generate preliminary comparative data on operative time, safety, stone clearance, postoperative recovery, and follow-up urinary outcomes to inform future adequately powered trials.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Beni Suweif Governorate
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Banī Suwayf, Beni Suweif Governorate, 이집트
- 모병
- Urology Department - Beni-Suef University Hospitals
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연락하다:
- Hany Fathy Badawy, MD
- 전화번호: +201149525028
- 이메일: Hanyfathy86@gmail.com
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연락하다:
- Mahmoud Abdallah, Md
- 전화번호: +20 11 55361979
- 이메일: Drhanyfathy86@gmail.com
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수석 연구원:
- Hany Fathy Badawy, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Children aged 2 to 14 years.
- Diagnosis of bladder stone or stones measuring 10-30 mm in maximum cumulative diameter, confirmed by ultrasound.
- Normal upper urinary tract.
- Fit for general anesthesia.
- Written informed consent obtained from parents or legal guardians.
Exclusion Criteria:
- Known urethral stricture or posterior urethral valves.
- Active urinary tract infection at the time of surgery.
- Coagulopathy or uncorrected bleeding disorder.
- Previous open bladder surgery.
- Any anatomical or clinical condition that, in the investigator's judgment, precludes safe endoscopic or percutaneous cystolithotripsy.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Vacuum-Assisted Mini-Percutaneous Cystolithotripsy
Participants randomized to this arm will undergo vacuum-assisted mini-percutaneous cystolithotripsy under general anesthesia using suprapubic percutaneous bladder access and a suction-assisted mini sheath.
Ho:YAG laser lithotripsy will be used for stone fragmentation, with suction-assisted evacuation of stone dust and fragments.
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Surgical treatment of pediatric bladder stones using suprapubic mini-percutaneous bladder access, a suction-assisted mini sheath, and Ho:YAG laser lithotripsy for stone fragmentation and evacuation
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활성 비교기: Transurethral Cystolithotripsy
Participants randomized to this arm will undergo standard transurethral cystolithotripsy under general anesthesia using the smallest appropriate pediatric semi-rigid ureteroscope.
Ho:YAG laser lithotripsy will be used for stone fragmentation, with fragment evacuation through the transurethral route
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Standard transurethral endoscopic treatment of pediatric bladder stones using an appropriate pediatric semi-rigid ureteroscope with Ho:YAG laser lithotripsy and transurethral fragment evacuation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Total Operative Time
기간: Intraoperative
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Total operative time will be defined as the time from insertion of the first endoscopic instrument to completion of stone clearance and urethral catheter placement, measured in minutes.
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Intraoperative
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Stone-Free Rate
기간: 4 weeks postoperatively
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Stone-free rate will be defined as the proportion of patients with no residual bladder stone fragments on postoperative pelvi abdominl ultrasound. Low-dose non-contrast CT urinary tract will be reserved for equivocal ultrasound findings. Time Frame: 4 weeks postoperatively |
4 weeks postoperatively
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Urethral Mucosal Injury
기간: Intraoperatively
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Occurrence of visible urethral mucosal injury detected intraoperatively.
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Intraoperatively
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Lithotripsy and Fragment Clearance Time
기간: Intraoperative
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Time from initiation of laser lithotripsy to endoscopic confirmation of complete stone clearance, measured in minutes.
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Intraoperative
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Recurrence or Urethral Stricture-Related Symptoms
기간: 6 months postoperatively
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Occurrence of recurrent bladder stone symptoms, abnormal urinary stream, suspected urethral stricture symptoms, or need for further diagnostic evaluation
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6 months postoperatively
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- FMBSUREC03032026Ahmed
- FMBSUREC/03032026/Ahmed (기타 식별자: FM-BSU REC)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Vacuum-Assisted Mini-Percutaneous Cystolithotripsy에 대한 임상 시험
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St. Joseph's Healthcare HamiltonUnity Health Toronto; Ontario Ministry of Health and Long Term Care; Women's College Hospital 그리고 다른 협력자들종료됨