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Enrolling by invitation NCT06394908

Registry of MIUS for Urolithiasis (ReMIUS-U)

Observational Urolithiasis Stone, Kidney Stone Ureter Complication of Surgical Procedure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Urolithiasis, Stone, Kidney, Stone Ureter, Complication of Surgical Procedure. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Registry of Minimally Invasive Urology Society for Urolithiasis Patients

Overview

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.

Primary outcome measures

  • Operative durations of each treatment technique (PCNL, SWL, URS, F-URS) [Time frame: Operation/procedure day]
  • Operative radiation dosage of each treatment technique (PCNL, SWL, URS, F-URS) [Time frame: Operation/procedure day]
  • Operative results of each treatment technique (PCNL, SWL, URS, F-URS) [Time frame: Operation/procedure day]
  • Postoperative results [Time frame: immediately after procedure]
  • Rate of postoperative complication [Time frame: up to 3 months, postoperatively]
  • Follow-up [Time frame: up to 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Marmara University Hospital — Istanbul

Identifiers

NCT: NCT06394908 · MIUS.2022.001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗