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
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Mostafa Mahmoud Rashed Ali, M.D
- 电话号码:+20111049435
- 邮箱:Mostafarashed2222@gmail.com
研究联系人备份
- 姓名:Atef Fathi Ali, professor
- 电话号码:+201099051714
- 邮箱:Ateffathi2010@yahoo.com
学习地点
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South Valley
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Qina、South Valley、埃及
- 招聘中
- South Valley University Hospital
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接触:
- Gamal Abdelhamid Alsagheer, Professor
- 电话号码:+201062487020
- 邮箱:alsagheer@med.svu.edu.eg
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接触:
- Omar Mohamed El-Saghir, Assist.Prof
- 电话号码:+201095421734
- 邮箱:Omarelsoqier1983@med.svu.edu.eg
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Percutaneous Nephrolithotomy Group
About 30 child suffering from renal stone will undergo mini percutaneous nephrolithotomy
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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.
其他名称:
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有源比较器:Retrograde Intrarenal Surgery Group
About 30 child suffering from renal stone will undergo retrograde intrarenal surgery
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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.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Measure Stone-Free Rate:
大体时间:6 months
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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.
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6 months
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合作者和调查者
调查人员
- 学习椅:Gamal Abdelhamid Alsagheer, Professor、Urology Department, Faculty of Medicine, South Valley University.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Pediatric Renal Stone
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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