Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: vacuum assisted sheath, passive suction via conventional sheath.
- Who it may be relevant to
- Registry conditions: Kidney Stone. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Device vacuum assisted sheath
allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval - Device passive suction via conventional sheath
conventional access sheath for stone retrieval using current technique via passive suction
Primary outcome measures
- Aim 1: Stone free rate [Time frame: 6 weeks]
- Aim 2: Intraoperative variables [Time frame: 3-7 days]
- Aim 3: Post-operative Outcomes and Complications [Time frame: 1 day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cleveland Clinic — Cleveland
Publications
- 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
Identifiers
NCT: NCT05993546 · 23-104