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Набор скоро начнётся NCT07516535

DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones

Без фазы С лечением Kidney Stones Nephrolithiasis Renal Calculi

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: Direct In-Scope Suction, Flexible and Navigable Suction Ureteric Access Sheath.
Кому может быть актуально
Состояния в реестре: Kidney Stones, Nephrolithiasis, Renal Calculi. Базовые параметры: 18 лет — 60 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
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Официальное название

The Impact of Suction-Assisted RIRS (DISS Versus FANS) on Postoperative Infection Rate and Stone-Free Rate After Treatment of Medium Sized Renal Stones

Обзор

Kidney stones are a common health problem and may recur frequently, which can affect quality of life and kidney function. Retrograde intrarenal surgery (RIRS) is a minimally invasive treatment used for renal stones, but treatment of medium-sized stones may be associated with longer operative time, impaired visibility during surgery, residual stone fragments, and postoperative infectious complications caused by increased intrarenal pressure. Suction-assisted retrograde intrarenal surgery (RIRS) techniques have been developed to improve surgical efficiency and safety by facilitating continuous removal of stone fragments and helping control intrarenal pressure. Two commonly used suction-assisted approaches are direct in-scope suction (DISS) and flexible and navigable suction ureteric access sheath (FANS). However, there is limited prospective randomized evidence directly comparing these two techniques. This randomized prospective clinical study aims to compare direct in-scope suction (DISS) versus flexible and navigable suction ureteric access sheath (FANS) in adult patients with medium-sized renal stones measuring 2 to 3 cm who are undergoing retrograde intrarenal surgery (RIRS). Participants will be randomly assigned to one of the two suction-assisted techniques. The study will evaluate whether flexible and navigable suction ureteric access sheath (FANS) provides better outcomes than direct in-scope suction (DISS) in terms of stone-free rate and postoperative infection rate. The primary outcome is stone-free status assessed by postoperative imaging. Secondary outcomes include operative time, intraoperative visibility, and postoperative complications, particularly infection and urosepsis. The study hypothesis is that suction-assisted retrograde intrarenal surgery (RIRS) using the flexible and navigable suction ureteric access sheath (FANS) technique will result in a higher stone-free rate and a lower postoperative infection rate compared with direct in-scope suction (DISS) in the management of medium-sized renal stones.

Вмешательства

  • Процедура Direct In-Scope Suction
    Direct suction is applied through the working channel of the flexible ureteroscope during retrograde intrarenal surgery to facilitate evacuation of stone fragments and improve intraoperative visibility during laser lithotripsy.
  • Процедура Flexible and Navigable Suction Ureteric Access Sheath
    A flexible and navigable suction ureteric access sheath is used during retrograde intrarenal surgery to provide suction-assisted evacuation of stone fragments, improve visibility, and support intrarenal pressure control during laser lithotripsy.

Первичные конечные точки

  • Stone-Free Rate [Срок оценки: At 1 month after surgery]
Вторичные конечные точки (4)
  • Postoperative Infection Rate [Срок оценки: Within 1 month after surgery]
  • Operative Time [Срок оценки: During surgery (Intraoperatively)]
  • Intraoperative Visibility Score [Срок оценки: During surgery (Intraoperatively)]
  • Postoperative Complication Rate [Срок оценки: Within 1 month after surgery]

Критерии участия

Критерии включения

  • Adults aged 18 to 60 years
  • Radiologically confirmed renal stones measuring 2 to 3 centimeters
  • Eligible for retrograde intrarenal surgery
  • Normal renal function as evidenced by normal serum creatinine
  • Able and willing to provide written informed consent

Критерии исключения

  • Pregnancy or lactation
  • Active urinary tract infection at the time of enrollment
  • Bleeding disorders or coagulopathies that contraindicate surgical intervention
  • Anatomical malformations affecting the urinary tract
  • Solitary kidney
  • Inability or unwillingness to provide informed consent

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
Открытое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Ain Shams University Hospitals — Cairo

Идентификаторы

NCT: NCT07516535 · FMASU MS 142/2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗