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

ConditionKidney Stone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Anticoagulated or history of coagulopathy

Congenital renal anomalies

Prior ipsilateral upper urinary tract reconstructive procedures

Conversion to open procedure

Trial design

Design model

Sequential

Treatments tested in this trial

  • vacuum assisted sheath

    Device

    allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval

  • passive suction via conventional sheath

    Device

    conventional access sheath for stone retrieval using current technique via passive suction

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: vacuum-assisted sheathActive comparator 1 intervention
Group B: passive suction via conventional sheathActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 weeks
2

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

Time frame
3-7 days
3

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

Time frame
1 day

Secondary outcomes

Other outcomes

Sponsors and contacts

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