Study of the Benefits of a Short Spa Treatment on the Elimination of Residual Lithic Fragments After Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Rate of SF patients (without fragment / stone free) in each arm, on the scanner and on the ASP.
研究概览
简要总结
Current urological therapeutic modalities are represented by extracorporeal lithotripsy (ECL), rigid (URS) or flexible (URSsple) uretero-renoscopy and percutaneous nephrolithotomy (PCNL).
They make it possible to extract the vast majority of stones by minimally invasive techniques but leave behind small residual lithic fragments (FR) that can always cause pain, infection, or promote the development of a larger stone.
A non-invasive technique that can help eliminate them would be of great benefit to many patients by avoiding painful recurrences and limiting reprocessing; combined with appropriate medical management, it would limit the rate of remote recurrences and long-term complications.
The treatment called "hydro-posturotherapy" has been developed in some spas that are approved for kidney diseases such as Vittel or Capvern. It includes several modalities: posturotherapy, lumbar percussion and hyperdiuresis.
The main objective is to compare at 3 months, on the unprepared abdomen (ASP) and the low-dose scanner without injection, the elimination of kidney stone fragments under the effect of a short spa treatment with posturotherapy, lumbar percussion and controlled hyperdiuresis compared to the recommended standard treatment. The result will be assessed in 3 categories: complete elimination (SF: "without fragments" or "stone-free"), elimination of more than 50% of the fragments; elimination of less than 50% of the fragments.
详细描述
Randomized multicenter controlled clinical trial comparing hydroposturotherapy in short thermal cure with standard hyperdiuresis in patients with residual stones, especially lower caliciels after urological treatment.
5 inclusion centres
- Central Hospital, Nancy
- Nancy Urology Center
- Clinique de la Croix du Sud in Toulouse
- Edouard Herriot Hospital in Lyon
The radiological images will be reviewed by the radiology department of the Central Hospital, Nancy.
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
- •Major patients with urinary stones who have received minimally invasive urological treatment: extracorporeal lithotripsy (ECL), flexible uretero-renoscopy (URSsple) and percutaneous nephrolithotomy (NLPC).
- •Patients with kidney stones less than 4 mm in size who are not receiving minimally invasive therapy.
- •Evaluation of the number, size / volume and location of calculations by ASP & TDM low-dose, without post-operative injection.
- •Information and signature of informed consent.
排除标准
- •Patients refusing a spa treatment
- •Contraindications to PTH: morbid obesity, unbalanced hypertension, pregnancy, respiratory failure, dizziness, vascular and/or ocular disorders, poly-mediated unbalanced cardiovascular pathology, orthostatic hypotension, general condition of the patient incompatible with the treatment
- •Patients with Cacchi Ricci disease
- •Person under the protection of justice, guardianship or curatorship
结局指标
主要结局
Rate of SF patients (without fragment / stone free) in each arm, on the scanner and on the ASP.
时间窗: 3 months after the patient's urological management
Estimate of the rate of patients for whom all fragments have been eliminated
次要结局
- Number of participants with complications related to residual stones or their evacuation(At inclusion, 1 month after inclusion, 3 months after inclusion)
- Medico-economic study of the benefit of the thermal cure(3 months after inclusion of patients in the cure group)
- Size of residual fragments in the cavities of the treated kidney at 3 months.(3 months after the patient's urological management)
- Quality of life questionnaire SF 36 : The Short Form (36) Health Survey(At inclusion, 1 month after inclusion, 3 months after inclusion)
- Number of intercurrent events(At inclusion, 1 month after inclusion, 3 months after inclusion)
研究者
GUILLEMIN Francis, MD
Professor
Central Hospital, Nancy, France