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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Stone

Intervention / Treatment
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* Device: vacuum assisted sheath
* Device: passive suction via conventional sheath


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vacuum-assisted sheath<br> | Device: vacuum assisted sheath<br>* allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval<br>|
| Active Comparator: passive suction via conventional sheath<br> | Device: passive suction via conventional sheath<br>* conventional access sheath for stone retrieval using current technique via passive suction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aim 1: Stone free rate | The primary outcome of SFR will be measured using conventional follow up of post-operative NCCT at 6 weeks. NCCT provides the most definitive assessment for post-operative stone burden and allows assessment of radiolucent stones when compared to ultrasound or abdominal x-ray | 6 weeks | 
| Aim 2: Intraoperative variables | Patients with positive cultures will be treated with appropriate pre-operative antibiotics between 3 to 7 days depending on symptoms. Antibiotics on day of surgery will be selected according to their last pre-operative urine culture which is our standard of care for patients undergoing PCNL | 3-7 days | 
| Aim 3: Post-operative Outcomes and Complications | Post-operative pain scores will be evaluated using a visual analogue scale (VAS) in the post-anesthesia care unit (PACU) and on postoperative day 1. The questionnaire may be filled out on a paper survey or an electronic REDCap survey sent via email. An electronic VAS has shown to be reliable and interchangeable with a paper VAS | 1 day |