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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Beni Suweif Governorate
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Banī Suwayf、Beni Suweif Governorate、エジプト
- 募集
- Urology Department - Beni-Suef University Hospitals
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コンタクト：
- Hany Fathy Badawy, MD
- 電話番号：+201149525028
- メール：Hanyfathy86@gmail.com
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コンタクト：
- Mahmoud Abdallah, Md
- 電話番号：+20 11 55361979
- メール：Drhanyfathy86@gmail.com
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主任研究者：
- Hany Fathy Badawy, MD
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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.
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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アクティブコンパレータ：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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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 |
|---|---|---|
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Total Operative Time
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Stone-Free Rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- FMBSUREC03032026Ahmed
- FMBSUREC/03032026/Ahmed (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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