Registry of Minimally Invasive Urology Society for Urolithiasis Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Rate of postoperative complication
研究概览
简要总结
The purpose of this registry is to collect data on patients who have undergone minimally invasive treatments for urinary system stone disease, including percutaneous nephrolithotomy (PCNL), shock wave lithotripsy (SWL), semi-rigid ureterorenoscopy (URS), and flexible ureterorenoscopy (F-URS).
详细描述
In this project, the Minimally Invasive Urology Association urolithiasis study group aimed to collect the data of adult and pediatric urinary system stone patients treated with PCNL, SWL, URS, and F-URS in a non-randomized, observational, and prospective manner. The registry was to be conducted multi-center in Turkey.
In this project, Excel files were created and shared via Google Drive with the responsible physicians at the centers to be included in the study. Each parameter was prepared in an explanatory manner and can be readily filled out by physicians familiar with these methods. The ability to examine and modify existing data will be restricted to the worker and the database administrator. Patients' identities will not be revealed in the registry.
The collected data are summarized in three sections under the major headings below;
- Demographics and preoperative information; Patient, disease, and treatment method demographic data, such as age, gender, height, weight, previous diseases, medications used, location, size, and hardness of urinary tract stones, the side of the stone, and the methods used for diagnosis, will be prospectively recorded for patients whose consent was obtained.
- Data during the operation; The duration of the operation as well as the devices and methods utilized will be recorded.
- In the postoperative period, post-treatment findings, such as stone-free status and post-treatment complications, will be documented.
A separate application to the ethics committee will be submitted for each study on the subject that will be created in the future from the multi-center, prospectively recorded data pool and on the subject that will be investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To have a medical indication for urolithiasis
- •Complete data of treatment and follow-up course
- •Patients with consent
- •Patients > 18 years-old
- •Patients < 18 years-old
排除标准
- •Missing data
- •Patients without consent
- •Not to have a medical indication for urolithiasis treatment
- •To have a contraindication for urolithiasis treatment
结局指标
主要结局
Rate of postoperative complication
时间窗: up to 3 months, postoperatively
Abnormal clinical and laboratory findings that may be seen after surgery and require additional intervention, treatment, or follow-up
Operative radiation dosage of each treatment technique (PCNL, SWL, URS, F-URS)
时间窗: Operation/procedure day
X-ray dosage
Operative durations of each treatment technique (PCNL, SWL, URS, F-URS)
时间窗: Operation/procedure day
The duration of the operation time
Operative results of each treatment technique (PCNL, SWL, URS, F-URS)
时间窗: Operation/procedure day
The duration of the laser time
Postoperative results
时间窗: immediately after procedure
Postoperative estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)
Follow-up
时间窗: up to 10 years
Follow-up results of patients for recurrence of disease of residual stones, if any reoperation records.
次要结局
未报告次要终点
研究者
Yiloren Tanidir
Associate professor
Marmara University
