Registry of MIUS for Urolithiasis (ReMIUS-U)
- Conditions
- UrolithiasisStone, KidneyComplication of Surgical ProcedureStone Ureter
- Registration Number
- NCT06394908
- Lead Sponsor
- Marmara University
- Brief Summary
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).
- Detailed Description
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;
1. 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.
2. Data during the operation; The duration of the operation as well as the devices and methods utilized will be recorded.
3. 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 10000
- 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
- Missing data
- Patients without consent
- Not to have a medical indication for urolithiasis treatment
- To have a contraindication for urolithiasis treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Operative radiation dosage of each treatment technique (PCNL, SWL, URS, F-URS) Operation/procedure day X-ray dosage
Rate of postoperative complication 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 durations of each treatment technique (PCNL, SWL, URS, F-URS) Operation/procedure day The duration of the operation time
Operative results of each treatment technique (PCNL, SWL, URS, F-URS) Operation/procedure day The duration of the laser time
Postoperative results immediately after procedure Postoperative estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)
Follow-up up to 10 years Follow-up results of patients for recurrence of disease of residual stones, if any reoperation records.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Marmara University Hospital
🇹🇷Istanbul, Turkey