Clinical trial NCT06394908: Registry of MIUS for Urolithiasis (ReMIUS-U)
Official title: Registry of Minimally Invasive Urology Society for Urolithiasis Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Urolithiasis
Stone, Kidney
Stone Ureter
Complication of Surgical Procedure
Keywords: Prospective studies
Registries
Urolithiasis
Lead sponsor: Marmara University
Sponsor class: OTHER
Collaborators: name: Samsun Education and Research Hospital
name: Gazi University
name: Koç University
name: Baskent University
name: Cukurova University
name: Ondokuz Mayıs University
name: Muğla Sıtkı Koçman University
name: Necmettin Erbakan University
name: Alanya Alaaddin Keykubat University
name: Dokuz Eylul University
name: Hitit University
First posted: 2024-05-01
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive urolithiasis treatment without contraindication

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Missing data
* Patients without consent
* Not to have a medical indication for urolithiasis treatment
* To have a contraindication for urolithiasis treatment

Primary outcomes:
measure: Operative durations of each treatment technique (PCNL, SWL, URS, F-URS)
timeFrame: Operation/procedure day
measure: Operative radiation dosage of each treatment technique (PCNL, SWL, URS, F-URS)
timeFrame: Operation/procedure day
measure: Operative results of each treatment technique (PCNL, SWL, URS, F-URS)
timeFrame: Operation/procedure day
measure: Postoperative results
timeFrame: immediately after procedure
measure: Rate of postoperative complication
timeFrame: up to 3 months, postoperatively
measure: Follow-up
timeFrame: up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Hospital
Study officials:
affiliation: Marmara University
name: yiloren tanidir, Assoc.Prof
role: STUDY_CHAIR
References: