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Набор по приглашению NCT06394908

Registry of MIUS for Urolithiasis (ReMIUS-U)

Наблюдательное Urolithiasis Stone, Kidney Stone Ureter Complication of Surgical Procedure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Urolithiasis, Stone, Kidney, Stone Ureter, Complication of Surgical Procedure. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Registry of Minimally Invasive Urology Society for Urolithiasis Patients

Обзор

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).

Подробное описание

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.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

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

Идентификаторы

NCT: NCT06394908 · MIUS.2022.001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗