Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

Обзор

The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Подробное описание

In this study we aim to compare two variations of the miniaturized percutaneous nephrolithotomy (Mini-PCNL) procedure which are both used for the surgical treatment of kidney stones. This procedure involves accessing the kidney via a small temporary tract that is placed through the patient's back during surgery. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Two procedure types will be investigated:

1. Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) vacuum-assisted tube with suction capability to assess the kidney and extract the stone. 2. Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) standard tube to assess the kidney and extract the stone.

Approximately 90 people will take part in this study at Cleveland Clinic. The duration of the study will include the day of the surgery and following hospital stay until postoperative follow-up appointment with the surgeon approximately 4-6 weeks after the procedure.

Вмешательства

• Устройство vacuum assisted sheath
  allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval
• Устройство passive suction via conventional sheath
  conventional access sheath for stone retrieval using current technique via passive suction

Первичные конечные точки

• Aim 1: Stone free rate [Срок оценки: 6 weeks]
• Aim 2: Intraoperative variables [Срок оценки: 3-7 days]
• Aim 3: Post-operative Outcomes and Complications [Срок оценки: 1 day]

Критерии участия

Критерии включения

• Patients with planned prone mini-PCNL and a preoperative NCCT
• Primary stone size: 10-25 mm
• Pre-existing indwelling nephrostomy tube or ureteral stent permitted
• Age: ≥ 18 years old
• Gender: all
• Ethnicity: all
• Capable of giving informed consent
• Capable and willing to fulfill requirements of the study

Критерии исключения

• Anticoagulated or history of coagulopathy
• Congenital renal anomalies
• Prior ipsilateral upper urinary tract reconstructive procedures
• Conversion to open procedure
• Multiple access tracts
• Inability to give informed consent or unable to meet requirements of the study for any reason

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Cleveland Clinic — Cleveland

Публикации

• Ho L, Chehroudi C, Sivalingam S. Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths for Treatment of Nephrolithiasis. J Urol. 2024 Sep;212(3):504-506. doi: 10.1097/JU.0000000000004057. Epub 2024 May 31. No abstract available. PMID 38820486

Идентификаторы

NCT: NCT05993546 · 23-104

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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