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Идёт набор NCT07076589

A Comparative Study Between the Usage of Flexible and Navigable Suction Ureteral Access Sheath Versus Traditional Access Sheath in Retrograde Intrarenal Surgeries

Без фазы С лечением Stones, Kidney Ureter Stones

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
В протоколе указаны: FURS.
Кому может быть актуально
Состояния в реестре: Stones, Kidney, Ureter Stones. Базовые параметры: от 14 лет · 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
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Comparative Study Between the Usage of Flexible and Navigable Suction Ureteral Access Sheath (FANS) Versus Traditional Access Sheath in RIRS : Randomized Controlled Trial

Обзор

A comparative study between the Usage of Flexible and Navigable Suction Ureteral Access Sheath (FANS) versus Traditional Access sheath in RIRS : Randomized controlled trial .

Подробное описание

Urinary calculus is a worldwide urological disease, with a prevalence ranging from 1% to 13% in different regions . Currently, the main therapeutic methods beyond conservative treatment for renal calculi include extracorporeal shock wave lithotripsy (ESWL) and minimally invasive endoscopic surgical methods, including percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS). Treatment plans depend on the characteristics of calculi, patient factors, surgeon experience and the condition of medical centers .

Technological advancements in RIRS have been numerous in recent years, with the introduction of single-use flexible ureteroscopes and higher-power lasers being the most notable. High intrarenal pressure (IRP) can lead to pyelovenous backflow and infection from transient bacteraemia, particularly during laser lithotripsy. Another major concern is the retention of residual fragments (RFs), which are pieces that are hidden from view because of the snow-globe effect .

Therefore, in order to facilitate the clearance of RF and enhance the overall performance of RIRS, a variety of adjuncts have been developed, including pressure sensors to regulate IRP, a direct in-scope vacuum technique to aspirate dust, and stone retrieval devices that utilize suction technologies .

These objectives are all designed to achieve the triumvirate of successful RIRS: a high stone-free rate (SFR), minimal ancillary interventions, and minimal complications-the ultimate goal of all RIRS surgeons .

The ureteral access sheath (UAS) has been used in RIRS to reduce IRP and hence infectious complications, as well as to improve drainage, stone clearance, and intraoperative vision, thus shortening operative time. However, there still remains some debate over the ideal UAS size - too large risks injuring the ureteral mucosa and causing ischaemia, while too small defeats its purpose of improving drainage .

The addition of suction to a traditional UAS resulted in the conception of suction ureteral access sheath (SUAS). As demonstrated in clinical studies, the SUAS has the potential to reduce intrarenal temperature and pressure, thus reducing infectious complications and improving SFR .

Nevertheless, the SUAS continues to exhibit certain constraints . If it is positioned below the uretero-pelvic junction (UPJ), as is the case with the traditional UAS, the application of suction results in the collapse of the proximal ureteral mucosa. This reduces the calibre of the narrow UPJ and impedes the aspiration of RF by acting as a functional valve to block the opening of the UAS. Despite being positioned across the UPJ, it is incapable of overcoming acute angles or reaching distant calyces to facilitate the complete aspiration of particulate that has settled in dependent calyces .

A flexible-tip SUAS, also known as the flexible and navigable suction UAS (FANS), was developed as a natural evolution. This SUAS could be navigated using the flexible scope. FANS can be securely maneuvered into individual calyces under fluoroscopic guidance to remove fragments and dust more thoroughly and targeted through suctioning .

Вмешательства

  • Процедура FURS
    FURS using traditional UAS \& FANS

Первичные конечные точки

  • • Stone-free rate (SFR). [Срок оценки: 12 weeks postoperatively]

Критерии участия

Критерии включения

  • Age ≥14 years old in patients not known to have stone forming medical conditions.
  • Renal stones diameter of ≤2 cm confirmed by CT with all types of configurations (branching \& non-branching).
  • Non - recurrent cases with no history of previous open renal surgeries or PCNL with normal renal anatomy.
  • Patients with non - infected urine analysis.

Критерии исключения

  • Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit).
  • Patients with medical conditions promoting stone formation (hyperparathyroidism - gout).
  • Patients with history of stones on the same side with previous open surgical intervention or PCNL .
  • Patients with e-GFR < 60 ml / min.
  • Patients with uncontrolled urinary tract infection.
  • Patients with health or other factors that are absolute contraindications to RIRS.
  • Patients who are unable to understand or complete trial documentation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Cairo university hospitals — Cairo

Идентификаторы

NCT: NCT07076589 · MS-210-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗