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临床试验/NCT06394908
NCT06394908Enrolling By Invitation不适用

Registry of Minimally Invasive Urology Society for Urolithiasis Patients

Marmara University1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2023年5月10日最近更新:
适应症

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;

  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.

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yiloren Tanidir

Associate professor

Marmara University

研究点 (1)

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