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 volunteersQualifiers
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
Sequential
Treatments tested in this trial
vacuum assisted sheath
Deviceallows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval
passive suction via conventional sheath
Deviceconventional access sheath for stone retrieval using current technique via passive suction
Treatment groups
Trial outcomes
Primary outcomes
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
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
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
Sponsors and contacts
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