Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones (DUST-FRAG-PED)
Dusting Versus Fragmentation With Holmium:YAG Laser During Transurethral Cystolithotripsy in Pediatric Bladder Stones: A Prospective Randomized Trial
Bladder stones are a clinically relevant pediatric urological condition that may require endoscopic treatment. Transurethral Holmium:YAG laser cystolithotripsy is a minimally invasive option for selected children with bladder stones.
This prospective randomized trial will compare two Holmium:YAG laser strategies during transurethral cystolithotripsy in children with a single bladder stone less than 3 cm: dusting and fragmentation. Children will be randomized to undergo laser dusting or laser fragmentation during transurethral cystolithotripsy.
The primary outcome is total operative time. Secondary outcomes include laser time, need for active fragment extraction, endoscopic stone-free status at the end of the procedure, ultrasound-assessed stone-free status during follow-up, intraoperative complications, postoperative urinary symptoms, urinary tract infection, need for postoperative catheterization, and hospital stay.
연구 개요
상태
상세 설명
This is a prospective randomized controlled trial conducted at the Department of Urology, Faculty of Medicine, Beni-Suef University Hospital.
The study will include children with radiologically confirmed single bladder stones less than 3 cm who are planned for transurethral Holmium:YAG laser cystolithotripsy and are suitable for transurethral endoscopic management under general anesthesia. Written informed consent will be obtained from parents or legal guardians before enrollment.
Eligible children will be randomized in a 1:1 ratio into two groups. Participants in the dusting group will undergo transurethral Holmium:YAG laser cystolithotripsy using low pulse energy and higher pulse frequency settings, with the aim of reducing the stone into fine particulate debris and tiny fragments with minimal need for active extraction. Participants in the fragmentation group will undergo transurethral Holmium:YAG laser cystolithotripsy using higher pulse energy and lower pulse frequency settings, with the aim of producing visible extractable fragments that can be actively removed when needed.
All procedures will be performed under general anesthesia in the lithotomy position using a pediatric semi-rigid ureteroscope. A Holmium:YAG laser will be used in both groups. The planned settings are 0.5-0.8 J and 10-15 Hz in the dusting group, and 1.0 J and 6-10 Hz in the fragmentation group. A 550-micron end-firing laser fiber will be preferred when compatible with the available endoscope.
The primary outcome is total operative time, defined as the time in minutes from insertion of the endoscope into the urethra until completion of stone clearance and termination of the procedure, including fragment retrieval when required. Secondary outcomes include laser time, need for active fragment extraction, endoscopic stone-free status at the end of the procedure, ultrasound-assessed stone-free status at follow-up, intraoperative mucosal injury or bleeding, need for postoperative catheterization, postoperative hematuria, dysuria, urinary tract infection, and hospital stay. Follow-up will be scheduled at 1 week, 1 month, and 3 months with clinical assessment and ultrasonography.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hany F Badawy, MD
- 전화번호: +201149525028
- 이메일: Hanyfathy86@gmail.com
연구 연락처 백업
- 이름: Ghada S Etman, MD
- 전화번호: +2010 07913852
- 이메일: DrhanYFATHY86@GMAIL.COM
연구 장소
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Beni Suweif Governorate
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Banī Suwayf, Beni Suweif Governorate, 이집트
- 모병
- Department of Urology- Beni-Suef University Hospitals
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연락하다:
- Hany F Badawy, MD
- 전화번호: +201149525028
- 이메일: Hanyfathy86@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Children aged less than 18 years.
- Radiologically confirmed single bladder stone less than 3 cm.
- Suitable for transurethral cystolithotripsy.
- Fit for general anesthesia.
- Written informed consent from parents or legal guardians.
Exclusion Criteria:
- Giant bladder stones more than 3 cm.
- Urethral pathology preventing safe transurethral access.
- Major lower urinary tract anomaly or neurogenic bladder.
- Active untreated urinary tract infection.
- Coagulation disorder or contraindication to endoscopic surgery.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Dusting
Participants will undergo transurethral Holmium:YAG laser cystolithotripsy using a dusting strategy with low pulse energy .
The planned settings are 0.5-0.8
J and 10-15 Hz, aiming to reduce the bladder stone into fine particulate debris and tiny fragments with minimal need for active fragment extraction.
|
Transurethral Holmium:YAG laser cystolithotripsy using a dusting strategy with planned laser settings of 0.5-0.8
J and 10-15 Hz, aiming to reduce the bladder stone into fine particulate debris and tiny fragments with minimal need for active fragment extraction.
|
|
활성 비교기: Fragmentation
Participants will undergo transurethral Holmium:YAG laser cystolithotripsy using a fragmentation strategy with higher pulse energy.
The planned settings are 1.0 J and 6-10 Hz, aiming to produce visible extractable stone fragments, approximately 2-5 mm, with active fragment removal when needed.
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Transurethral Holmium:YAG laser cystolithotripsy using a fragmentation strategy with planned laser settings of 1.0 J and 6-10 Hz, aiming to produce visible extractable stone fragments of approximately 2-5 mm, with active fragment removal when needed.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total Operative Time
기간: During the index transurethral cystolithotripsy procedure
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Total operative time will be measured in minutes from insertion of the endoscope into the urethra until completion of bladder stone clearance and termination of the procedure, including active fragment retrieval when required.
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During the index transurethral cystolithotripsy procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Laser Time
기간: During the index transurethral cystolithotripsy procedure
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Laser time will be measured in minutes as the cumulative duration of active Holmium:YAG laser firing during the index transurethral cystolithotripsy procedure.
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During the index transurethral cystolithotripsy procedure
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Need for Active Fragment Extraction
기간: During the index transurethral cystolithotripsy procedure
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The need for active fragment extraction will be recorded as whether stone fragments required active removal using endoscopic retrieval maneuvers during the index transurethral cystolithotripsy procedure. |
During the index transurethral cystolithotripsy procedure
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Endoscopic Stone-Free Status at the End of the Procedure
기간: At the end of the index transurethral cystolithotripsy proced
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Endoscopic stone-free status will be assessed at the end of the procedure and defined as no visible residual bladder stone fragments on final endoscopic inspection.
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At the end of the index transurethral cystolithotripsy proced
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Postoperative Hematuria
기간: From the end of the procedure to 1 month postoperatively
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Postoperative hematuria will be recorded based on clinical observation or patient/guardian report during postoperativ follow-up.
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From the end of the procedure to 1 month postoperatively
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hany F Badawy, MD, Faculty of Medicine, Beni-Suef University hospital
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- FMBSUREC05052026BadawyDF
- FMBSUREC/05052026/Badawy (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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