Efficacy and Safety of Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy in Management of Staghorn Stones: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Stone free rate
研究概览
简要总结
Percutaneous nephrolithotomy (PCNL) is considered the treatment of choice for management of large renal calculi larger than 2 cm based on the yearly updated European Association of Urology (EAU) guidelines. However, PCNL is a challenging procedure which may be associated with several complications ranging from mild complications, such as urinary extravasation, leakage, infection and bleeding requiring transfusion to sever complications, such as sepsis, injury to surrounding organs, persistent hematuria and renal function impairment. The overall complication rate varies based on patient factors and surgical expertise.
Not only serious complications that defer some endourologists from performing PCNL but also such procedure is contraindicated and avoided by surgeons in cases of retrorenal colon, morbidly obese patients, spinal abnormalities and bleeding diathesis. Therefore, retrograde intrarenal surgery (RIRS) or flexible ureteroscopy (FURS) is increasingly recognized as an effective alternative, particularly for patients seeking a minimally invasive approach with a lower risk of complications.
The best practice in dealing with renal stones using FURS can be achieved via preoperative stenting for 2-4 weeks, negative urine culture, ureteral access sheath (UAS) usage and optimizing laser settings. Compared to PCNL, FURS is a less challenging procedure with low learning curve, less invasive and less bleeding. However, the high cost, including laser usage cost, presenting costs and multisession costs, in addition to the high risk of postoperative infection are considered as major drawbacks of FURS.
RIRS is emerging as an effective, safe, minimally invasive alternative to PCNL. Yet, the success of RIRS in comparison to PCNL, especially in a single session, is still questionable and there is no consensus about it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years.
- •Diagnosis of complete staghorn renal stones confirmed by non-contrast CT.
- •Negative urine culture.
排除标准
- •Congenital renal anomalies (e.g., horseshoe kidney, malrotation).
- •Coagulopathy or uncorrected bleeding disorder.
- •Pregnancy.
- •Previous ipsilateral renal surgery.
研究组 & 干预措施
PCNL group
patients of this group will undergo percutanous nephrolithotomy
干预措施: Percutaneous nephrolithotomy (Procedure)
FURS group
Patients of this group will undergo flexible ureteroscopy
干预措施: Flexible ureteroscopy (Procedure)
结局指标
主要结局
Stone free rate
时间窗: 1 Month
Stone-free rate (SFR), defined as no clinically significant residual stones on non-contrast 3-mm-cuts CT, measured as yes or no.
次要结局
- Operative time(During the surgery)
- Complications(1 month)
- Radiation time(During the surgery)
研究者
Ammar Fathi Mohamed AlOrabi
Principle investigator
Menoufia University
