Efficacy and Safety of Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy in Management of Staghorn Stones

Официальное название

Efficacy and Safety of Flexible Ureteroscopy Versus Percutaneous Nephrolithotomy in Management of Staghorn Stones: A Randomized Controlled Trial

Обзор

Percutaneous nephrolithotomy (PCNL) is considered the treatment of choice for management of large renal calculi larger than 2 cm based on the yearly updated European Association of Urology (EAU) guidelines. However, PCNL is a challenging procedure which may be associated with several complications ranging from mild complications, such as urinary extravasation, leakage, infection and bleeding requiring transfusion to sever complications, such as sepsis, injury to surrounding organs, persistent hematuria and renal function impairment. The overall complication rate varies based on patient factors and surgical expertise. Not only serious complications that defer some endourologists from performing PCNL but also such procedure is contraindicated and avoided by surgeons in cases of retrorenal colon, morbidly obese patients, spinal abnormalities and bleeding diathesis. Therefore, retrograde intrarenal surgery (RIRS) or flexible ureteroscopy (FURS) is increasingly recognized as an effective alternative, particularly for patients seeking a minimally invasive approach with a lower risk of complications. The best practice in dealing with renal stones using FURS can be achieved via preoperative stenting for 2-4 weeks, negative urine culture, ureteral access sheath (UAS) usage and optimizing laser settings. Compared to PCNL, FURS is a less challenging procedure with low learning curve, less invasive and less bleeding. However, the high cost, including laser usage cost, presenting costs and multisession costs, in addition to the high risk of postoperative infection are considered as major drawbacks of FURS. RIRS is emerging as an effective, safe, minimally invasive alternative to PCNL. Yet, the success of RIRS in comparison to PCNL, especially in a single session, is still questionable and there is no consensus about it.

Вмешательства

• Процедура Percutaneous nephrolithotomy
  This intervention includes percutaneous nephrolithotomy for lithotripsy of staghorn stone
• Процедура Flexible ureteroscopy
  This intervention includes Flexible ureteroscopy for lithotripsy of staghorn stone

Первичные конечные точки

• Stone free rate [Срок оценки: 1 Month]

Вторичные конечные точки (3)

• Operative time [Срок оценки: During the surgery]
• Complications [Срок оценки: 1 month]
• Radiation time [Срок оценки: During the surgery]

Критерии участия

Критерии включения

• Adults aged ≥18 years.
• Diagnosis of complete staghorn renal stones confirmed by non-contrast CT.
• Negative urine culture.

Критерии исключения

• Congenital renal anomalies (e.g., horseshoe kidney, malrotation).
• Coagulopathy or uncorrected bleeding disorder.
• Pregnancy.
• Previous ipsilateral renal surgery.

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

• Menoufia Faculty of Medicine — Shebin El-Kom

Идентификаторы

NCT: NCT07322471 · PCNL vs FURS in staghorn stone

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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