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

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:

• 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.
• 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.

Inclusion criteria

• 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

Exclusion criteria

• 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