Retrograde Intrarenal Surgery Versus Mini Percutaneous Nephrolithotomy
Retrograde Intrarenal Surgery Versus Mini Percutaneous Nephrolithotomy In Management Of Pediatric Renal Stone Less Than 2 Cm: A Prospective Randomized Study
調査の概要
詳細な説明
Pediatric nephrolithiasis accounts for approximately 2-3% of all stone disease cases, with recent reports indicating a rising prevalence of up to 10.6%.Multiple treatment modalities are currently available, ranging from non-invasive pharmacologic options to minimally invasive techniques such as extracorporeal shockwave lithotripsy (ESWL), retrograde intrarenal surgery (RIRS), and percutaneous nephrolithotomy (PCNL).
Treatment selection is primarily guided by stone size, location, and complexity. Importantly, the chosen intervention should aim to achieve a high stone-free rate (SFR) with the lowest possible complication rate.
Minimally invasive technique is considered the first-line of treatment for renal stones in children due to its favorable safety profile and minimally invasive nature. In such cases, endourological options like RIRS and mini-PCNL serve as favourable line of treatments.
RIRS is a minimally invasive procedure that offers advantages such as reduced perioperative morbidity, lower bleeding risk, and quicker recovery compared to mini PCNL. Nonetheless, its stone clearance rate may be inferior to mini PCNL, particularly for larger stones. RIRS often requires DJ stenting and may lead to repeated interventions, which can result in lower urinary tract symptoms (LUTS) and negative impact on quality of life.
Mini-PCNL, although highly effective, carries a higher risk of complications, including bleeding and adjucnt oragan injury particularly due to tract dilation.To reduce these risks, modified PCNL techniques have been introduced, such as ultramini-PCNL, and micro-PCNL. These smaller-caliber systems have demonstrated greater safety profiles in children and higher efficacy than ESWL, making them promising in pediatric stone management.
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:Mostafa Mahmoud Rashed Ali, M.D
- 電話番号:+20111049435
- メール:Mostafarashed2222@gmail.com
研究連絡先のバックアップ
- 名前:Atef Fathi Ali, professor
- 電話番号:+201099051714
- メール:Ateffathi2010@yahoo.com
研究場所
-
-
South Valley
-
Qina、South Valley、エジプト
- 募集
- South Valley University Hospital
-
コンタクト:
- Gamal Abdelhamid Alsagheer, Professor
- 電話番号:+201062487020
- メール:alsagheer@med.svu.edu.eg
-
コンタクト:
- Omar Mohamed El-Saghir, Assist.Prof
- 電話番号:+201095421734
- メール:Omarelsoqier1983@med.svu.edu.eg
-
-
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 1 to 18 years .
- Presence of a renal stone ≤2 cm in maximum diameter (single or multiple).
- Stone located in the renal pelvis and/or calyces.
- Normal renal function (based on age-adjusted serum creatinine and/or eGFR).
- No prior surgical intervention for the current stone episode.
Exclusion Criteria:
- Anatomical abnormalities of the urinary tract (e.g., ureteropelvic junction obstruction, horseshoe kidney).
- Bleeding disorders or uncorrected coagulopathy.
- Active urinary tract infection at the time of surgery.
- Patients with contraindications to general anesthesia.
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:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ:Percutaneous Nephrolithotomy Group
About 30 child suffering from renal stone will undergo mini percutaneous nephrolithotomy
|
to compare the efficacy and safety of retrograde intrarenal surgery (RIRS) versus mini-percutaneous nephrolithotomy (mini-PCNL) in the management of renal stones ≤2 cm in pediatric patients.
他の名前:
|
|
アクティブコンパレータ:Retrograde Intrarenal Surgery Group
About 30 child suffering from renal stone will undergo retrograde intrarenal surgery
|
to compare the efficacy and safety of retrograde intrarenal surgery (RIRS) versus mini-percutaneous nephrolithotomy (mini-PCNL) in the management of renal stones ≤2 cm in pediatric patients.
他の名前:
|
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 |
|---|---|---|
|
Measure Stone-Free Rate:
時間枠:6 months
|
Defined as the absence of residual stones or the presence of clinically insignificant residual fragments (CIRF) <4 mm or absent and this will be better results, but if Clinical significant residual fragments > or Equal 4 mm may need Auxillary procedure Evaluation the patients after the operation by Stone-Free Rate as an indicator of surgical success.
|
6 months
|
協力者と研究者
スポンサー
捜査官
- スタディチェア:Gamal Abdelhamid Alsagheer, Professor、Urology Department, Faculty of Medicine, South Valley University.
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
その他の研究ID番号
- Pediatric Renal Stone
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?
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。