Retrospective and Prospective Study of Patients Suffering From Nephrolithiasis Undergoing Surgery Using a Minimally Invasive Endoscopic Approach.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Eating habits
研究概览
简要总结
Retrospective and prospective study on patients suffering from nephrolithiasis who undergo minimally invasive surgery of the upper excretory system; correlation between the phenotypic and genotypic aspects of the patients and the stone pathology treated with an endoscopic surgical approach.
详细描述
Clinical data will be collected from patients suffering from kidney stones before and after surgery, in order to demonstrate how the endoscopic approach can not only be effective in treating kidney stones but also reduce operative complications.
These data will be collected in a database in order to be able to perform statistical analyzes useful for demonstrating our theory.
Furthermore, data from the surgery will be collected regarding the endoscopic instruments used and the intraoperative findings (site, size, appearance of the stone), degree of calcification of the renal papillae.
All this in order to improve the therapeutic approach to patients suffering from stones and reduce the risk of recurrence over time through the identification of genetic expression patterns that predispose to the expression of the stone phenotype.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •subjects suffering from kidney stones or tumors of the upper excretory tract >= 18 years
- •signature of informed consent
排除标准
- •subjects < 18 years
- •presence of mental or physical disability that may prevent the patient from answering the questionnaires.
结局指标
主要结局
Eating habits
时间窗: Baseline and after 6 months
Eating habits through an ad-hoc eating habits questionnaire
Prostatic Function
时间窗: Baseline and after 6 months
Prostatic Function through the International Prostatic Symptoms Score questionnaire, IPSS, Scoring 0 -7, 0-7 mild symptoms, 8-19 moderate symptoms, 20-35 severe symptoms.
Clinical data
时间窗: Baseline and after 6 months
Medical history: patient's medical history, past surgical history, family medical history, social history, allergies, and medications; physical examination: vital signs, temperature examination, blood pressure, pulse, and respiratory rate blood chemistry and instrumental test reports: Serum PSA levels, conventional imaging
次要结局
未报告次要终点
研究者
Andrea Salonia
Professor
IRCCS San Raffaele