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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Hany F Badawy, MD
- 電話番号：+201149525028
- メール：HANYFATHY86@GMAIL.COM
研究連絡先のバックアップ
- 名前：Ghada S Etman, MD
- 電話番号：+2010 07913852
- メール：DrhanYFATHY86@GMAIL.COM
研究場所
-
-
Beni Suweif Governorate
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Banī Suwayf、Beni Suweif Governorate、エジプト
- 募集
- Department of Urology- Beni-Suef University Hospitals
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コンタクト：
- Hany F Badawy, MD
- 電話番号：+201149525028
- メール：HANYFATHY86@GMAIL.COM
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
アクティブコンパレータ：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Operative Time
時間枠：During the index transurethral cystolithotripsy procedure
|
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.
|
During the index transurethral cystolithotripsy procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Laser Time
時間枠：During the index transurethral cystolithotripsy procedure
|
Laser time will be measured in minutes as the cumulative duration of active Holmium:YAG laser firing during the index transurethral cystolithotripsy procedure.
|
During the index transurethral cystolithotripsy procedure
|
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Need for Active Fragment Extraction
時間枠：During the index transurethral cystolithotripsy procedure
|
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
|
|
Endoscopic Stone-Free Status at the End of the Procedure
時間枠：At the end of the index transurethral cystolithotripsy proced
|
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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Hany F Badawy, MD、Faculty of Medicine, Beni-Suef University hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- FMBSUREC05052026BadawyDF
- FMBSUREC/05052026/Badawy (その他の識別子：FM-BSU REC)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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