Using Retrograde Intrarenal Surgery for Managing Staghorn Renal 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: Retrograde intrarenal surgery.
- Кому может быть актуально
- Состояния в реестре: Renal Calculi. Базовые параметры: 18 лет — 70 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 →
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Официальное название
Using Bendable Tip-suction Ureteral Access Sheath Compared to Conventional Sheath in Managing Renal Staghorn Stones A Randomized Prospective Study
Обзор
This prospective, randomized study is comparing the safety and efficacy of using two types of ureteral access sheaths in managing staghorn renal stones by retrograde intrarenal surgery.
Подробное описание
Staghorn renal calculi is a complex type of renal calculi characterized by their filling of the renal pelvis and branching into all or part of the renal calyces.
Percutaneous nephrolithotomy (PCNL) is currently the recommended primary treatment option for staghorn renal calculi. However, the procedure has significant drawbacks, including invasiveness, postoperative bleeding, infection, prolonged hospitalization, and slow recovery. Retrograde Intrarenal Surgery (RIRS), an effective minimally invasive procedure, has become the first-line treatment for stones smaller than 2cm. With advancements in endoscopic equipment and techniques, RIRS is also being gradually utilized for the treatment of staghorn renal calculi in patients who are not suitable for PCNL.
Ureteral access sheath (UAS) is an important tool for the endourologist. Advantages of using a UAS in ureteroscopy include: ena¬bling repeated passage of the ureteroscope while mini¬mizing damage, improving the flow of irrigation fluid and visualization within the ureter, reducing operative times, reducing the costs of procedures and improving the effectiveness of surgery.
Intending to overcome the shortages of RIRS, a patented ureter access sheath with features of suction and bendable-tip is designed. The tip of the innovated ureteral access sheath can reach the target calyx along with the flexible ureteroscope.
The adjustable continuous negative pressure suction ensures sufficient irrigation speed and maintains a clear surgical field of view, while effectively removing fragmented stones and dust, and reducing the thermal energy generated by laser lithotripsy.
Вмешательства
- Процедура Retrograde intrarenal surgery
Retrograde intrarenal surgery with using laser for management of renal staghorn stones
Первичные конечные точки
- Safety of the surgical technique [Срок оценки: During surgery to one month after surgery]
Вторичные конечные точки (1)
- The efficacy of the surgery [Срок оценки: One month after surgery]
Критерии участия
Критерии включения
- Adult patients of both sexes.
- Patient has a staghorn renal stone (complete or partial staghorn).
- Normal renal function tests.
- Congenital renal anomalies as horseshoe, pelvic or mal-rotated kidneys.
Критерии исключения
- Abnormal coagulation profile.
- Active or untreated urinary tract infection.
- Age under 18 years or above 70 years.
- Patient has a staghorn stone associated with other pathology which requires additional intervention, as ureteral stricture or ureteropelvic junction obstruction (UPJO).
- Pregnancy.
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
- Faculty of medicine, Helwan University — Cairo
Публикации
- Bai Y, Wang X, Yang Y, Han P, Wang J. Percutaneous nephrolithotomy versus retrograde intrarenal surgery for the treatment of kidney stones up to 2 cm in patients with solitary kidney: a single centre experience. BMC Urol. 2017 Jan 18;17(1):9. doi: 10.1186/s12894-017-0200-z. PMID 28100225
- Liang H, Liang L, Lin Y, Yu Y, Xu X, Liang Z, Sheng J, Shen B. Application of tip-bendable ureteral access sheath in flexible ureteroscopic lithotripsy: an initial experience of 224 cases. BMC Urol. 2023 Nov 1;23(1):175. doi: 10.1186/s12894-023-01347-x. PMID 37915008
- Kaplan AG, Lipkin ME, Scales CD Jr, Preminger GM. Use of ureteral access sheaths in ureteroscopy. Nat Rev Urol. 2016 Mar;13(3):135-40. doi: 10.1038/nrurol.2015.271. Epub 2015 Nov 24. PMID 26597613
- Zeng G, Zhao Z, Mazzon G, Pearle M, Choong S, Skolarikos A, Denstedt J, Seitz C, Olvera Pasada D, Fiori C, Bosio A, Papatsoris A, Mendez Probst CE, Perez Fentes D, Ann Git K, Wu Q, Wiseman O, Emiliani E, Farahat Y, Ilker Gokce M, Giannakopoulos S, Goumas Kartalas I, Somani B, Knoll T, de la Rosette J, Zhong J, Vinicius Maroccolo M, Saltirov L, Chew B, Wang K, Lahme S, Giusti G, Ferretti S, Yong Ch PMID 34836838
- Keller EX, De Coninck V, Doizi S, Traxer O. The role of ureteroscopy for treatment of staghorn calculi: A systematic review. Asian J Urol. 2020 Apr;7(2):110-115. doi: 10.1016/j.ajur.2019.10.012. Epub 2019 Dec 5. PMID 32257803
Идентификаторы
NCT: NCT07342361 · 129-2025