Mini-PNL, RIRS, and ESWL for Treatment of Medium-Sized, High-Density, Non-Lower Pole, Renal Stones: A Prospective, Randomized, Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 2
- 主要终点
- Stone-free rate
研究概览
简要总结
The optimal management of medium-sized renal stones remains quite challenging and continues to be contested. In the present study, the investigators will compare mini-PNL, RIRS and SWL in the treatment of non- lower pole, medium size, high dense renal stones regarding the stone-free rate, the safety of the procedures, cost, and patients' and surgeon's satisfaction. Eligible patients will be randomly allocated into three equal groups (mini-PNL, RIRS, and SWL). Postoperative, patients will be followed-up by regularly for 3 months. The study parameters will be compared between groups.
详细描述
The treatment options for renal stones 10-20 mm include either extracorporeal shock wave lithotripsy (SWL) or endourology (retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL).
SWL is an attractive treatment option for renal stones because it is non-invasive and more acceptable for the patient and can be done under analgesia, sedation, or minimal anaesthesia. However, the limitation of SWL includes a relatively lower stone-free rate (SFR) and the need for repeated sessions and auxiliary procedures. The SFR after SWL is affected by several factors, including body mass index (BMI), stone size, intrarenal stone location, skin-to-stone distance (SSD), and stone density.
The EAU guidelines put endourology and SWL as two equal options in medium-sized non-lower pole renal stones and did not give special attention to the stone density, which is an important predictor for SWL outcome. Several studies reported that the number of SWL sessions increased with increased stone attenuation value (SAV) and SFR decreased significantly in high-density renal stone.
PNL and RIRS have good SFR compared to SWL but might entail a significant risk of morbidity. The improved fURS instrumentation and lithotripsy technology, and development of the miniaturized PNL technique, may lower the procedure-related complications and mPNL and RIRS an alternative and excellent option for medium-sized and even large renal stones The investigators hypothesize that addressing the stone density factor may give a clear recommendation for medium-sized, high-density renal stones. They expected the superiority for either mPNL or RIRS, regarding SFR, without increased morbidity.
The study aims to compare the outcome of mPNL, RIRS, and SWL for treatment of non-lower pole, high-density renal stones of 10 to 20 mm size.
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
- •Adult patients (both genders)
- •Single non-lower pole renal stone.
- •Stone size: 10-20 mm.
- •Stone density: > 1000 HU.
排除标准
- •Pregnant women.
- •Morbid obesity.
- •Severe orthopaedic deformities.
- •Co-morbidities precluding general anaesthesia or prone positioning.
- •Uncorrectable coagulation disorders.
- •Active urinary tract infection (UTI).
- •Stone in a calyceal diverticulum.
- •Abnormal renal anatomy.
- •Urinary tract obstruction distal to the stone.
- •Concomitant pathology that needs intervention in the same setting.
- •Advanced hydronephrosis.
研究组 & 干预措施
mini-PNL group
In which PCNL will be performed using miniature nephroscope
干预措施: mini-PNL (Procedure)
RIRS group
In which RIRS will be performed using a flexible ureteroscope
干预措施: RIRS (Procedure)
SWL group
In which extracorporeal shock wave lithotripsy will be performed using Dornier lithotripter SII
干预措施: SWL (Procedure)
结局指标
主要结局
Stone-free rate
时间窗: as detected by non-contrasted computed tomography 3 months after the intervention procedures.
Stone free status is defined as no residual renal stone or residual fragment(s) less than 4 mm size.
Complication rate
时间窗: up to 3 months.
intra- and post-operative complications
次要结局
- Patients satisfaction(throughout the study procedure, up to 3 months post-operative)
- Cost of treatment(throughout the study procedure, up to 3 months post-operative.)
- Surgeon's satisfaction.(throughout the study procedure, up to 3 months post-operative)
研究者
Abul-fotouh Ahmed
Professor of Urology and Andrology
Al-Azhar University